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as at 1 December 2011
Medicines Regulations 1984
David Beattie, Governor-General Order in Council
At the Government House at Wellington this 5th day of June 1984 His Excellency the Governor-General in Council Pursuant of the Medicines Act 1981, and, in the caseof the regulations, of that Act, His Excellencythe Governor-General, acting on the advice of the Minister of Healthtendered after consultation with the organisations and bodies that ap-peared to the Minister to be representatives of persons likely to besubstantially affected, and by and with the advice and consent of theExecutive Council, hereby makes the following regulations.
Note
Changes authorised by of the Acts and Regulations Publication Act 1989
have been made in this reprint.
A general outline of these changes is set out in the notes at the end of this reprint, together
with other explanatory material about this reprint.
These regulations are administered by the Ministry of Health.
Medicines Regulations 1984
Reprinted as at1 December 2011 Medicines Regulations 1984
Medicines Regulations 1984
Reprinted as at1 December 2011 Medicines Regulations 1984
Title and commencement
These regulations may be cited as the Medicines Regulations1984.
These regulations shall come into force on 1 August 1984.
In these regulations, unless the context otherwise requires,— Act means the
appropriate designation, in relation to a medicine, or an in-
gredient of a medicine, or a related product, or an active ingre-
Medicines Regulations 1984
dient of a related product, has the following meaning in eachof the cases specified:(a) where the medicine, related product, or ingredient isnamed or described in a monograph contained in thecurrent edition of a specified publication, the termmeans the name or one of the synonyms used in thatspecified publication for that medicine, related product,or ingredient: where the medicine, related product, or ingredient—(i) is not named or described in a monograph con-tained in the current edition of any specified pub-lication but was named or described in a mono-graph contained in an earlier edition; and is not sold under any name or description exceptthe name or one of the synonyms used in thatearlier edition for that medicine, related product,or ingredient,— the term means the name or one of the synonyms soused in that earlier edition followed immediately by areference to that earlier edition: where neither paragraph (a) nor paragraph (b) applies,the term means—(i) the international non-proprietary name of themedicine, related product, or ingredient; or if it has no international non-proprietary name,the name appearing in a list published in theUnited Kingdom on the recommendation of theMedicines Commission pursuant to section 100of the Medicines Act 1968 (UK); or if the medicine, related product, or ingredient hasneither an international non-proprietary name nora name appearing in a list referred to in subpara-graph (ii), its accepted scientific name or someother name descriptive of the true nature of themedicine, related product, or ingredient appropriate quantitative particulars, in relation to any ac-
tive ingredients of a medicine or of a related product,—
(a)
where the medicine or related product consists of orcomprises tablets, capsules, or other separate portions, Reprinted as at1 December 2011 Medicines Regulations 1984
means the quantity (expressed by weight or volume) ofeach of the ingredients contained in each portion; or in any other case, means the percentage of each of thoseingredients contained in the medicine or related prod-uct, or the quantity of each of those ingredients con-tained in a stated quantity of the medicine or relatedproduct approved immunisation programme means a vaccination
programme—
(a)
pursuant to the National Immunisation Schedule of theMinistry of Health; or approved by the Director-General or a Medical Officerof Health an antitoxin; and a blood fractionation preparation; and a preparation from a mammalian gland; and any other substance or preparation that is similar in na-ture to any of those specified in paragraphs (a) to (h),— whether natural or synthetic, that is intended for diagnostic,prophylactic, or therapeutic purposes consent to distribute, in relation to any medicine or related
product, means a consent to the distribution of that medicine
or related product given by the Minister under of the
Act; and includes a provisional consent given of the Act
controlled drug has the same meaning as in
described, in relation to any medicine, related product, or
medical device, means represented or held out (whether in
writing or otherwise) by the manufacturer, seller, or supplier
of the medicine, related product, or medical device
Medicines Regulations 1984
dispensary technician means a person who holds a certificate
issued by the Pharmaceutical Society of New Zealand before
18 September 2004 that—
(a)
classifies the holder as a dispensary assistant; or records that the person has completed the requirementsof the Pharmacy Technicians Certificate for external use, in relation to any medicine or related prod-
uct, means for application to the anal canal, ear, eye, mucosa
of the mouth, nose, skin, teeth, throat, or vagina, where local
action only is required and where extensive systemic absorp-
tion will not occur; but nothing in these regulations relating to
medicines or related products intended for external use shall
apply to nasal drops, nasal inhalations, nasal sprays, teething
applications, throat lozenges, throat pastilles, throat sprays, or
throat tablets
general sale medicine has the meaning given to it of the Act
Pharmacy Council means the Pharmacy Council established
of the Health Practitioners Competence As-
surance Act 2003
pharmacy graduate means a person who is not a pharmacist,
but who—
(a)
has 1 or more of the qualifications prescribed by thePharmacy Council under of the HealthPractitioners Competence Assurance Act 2003 forregistration as a pharmacist; and is actively taking steps towards registration as apharmacist pharmacy student means a person who is undertaking, but
has not yet completed, the course and examinations leading to
a qualification of a kind prescribed by the Pharmacy Council
under of the Health Practitioners Competence
Assurance Act 2003
pharmacy technician means any person who has a National
Certificate in Pharmacy (Technician)
pharmacy technician student means a person who is under-
taking, but who has not yet completed, training and examin-
Reprinted as at1 December 2011 Medicines Regulations 1984
ations leading to a National Certificate in Pharmacy (Techni-cian) poison bottle means a container that is made of glass, plastic,
or other like material, and that either—
(a)
has embossed on at least one-third of its outer surfacenarrow flutings, ribs, nettings, or points, or other similarsurface impressions readily recognisable by touch; or has clearly embossed on 2 opposite sides of the shoulderof the container the word "POISON" in capital letters,the height of the letters being not less than half the widthof that shoulder principal display panel means the part of a label that is most
likely to be displayed, presented, shown, or examined under
ordinary or customary conditions of display; and, if such like-
lihood is equal in respect of 2 or more panels, means every
such panel
printed includes written, typewritten, engraved, lithographed,
or otherwise traced or copied
registered midwife means a health practitioner who is, or is
deemed to be, registered with the Midwifery Council estab-
lished by of the Health Practitioners Compe-
tence Assurance Act 2003 as a practitioner of the profession
of midwifery
safety container means a container, whether or not part of a
strip of containers, that—
(a)
encloses a single tablet or other single item of amedicine that is a solid or a class of medicines that aresolids (including a medicine or class of medicines inpowder form); and is made of aluminium foil or laminated plastic, or suchother material as may be approved by the Director-Gen-eral in relation to the packaging of any solid medicineto which applies, either by notice in theGazette or in writing addressed to a particular manufac-turer, packer, importer, or seller of medicines; and is reasonably resistant to attempts by young children toopen it Medicines Regulations 1984
specified publication means a publication named of the Act
student means a pharmacy student or a pharmacy technician
student.
In these regulations, unless the context otherwise requires, allreferences to proportions in a medicine (whether as percent-ages, parts per million, or otherwise) shall be references to—(a) proportions by weight, where the medicine is a solid; or proportions by volume, where the medicine is a liquidat ambient temperatures.
Regulation 2(1) approved immunisation programme: inserted, on 17 April
1992, by regulation 2 of the Medicines Regulations 1984, Amendment No 5
(SR 1992/43).
Regulation 2(1) approved immunisation programme: amended, on 1 July
1993, pursuant of the Health Amendment Act 1993 (1993
No 24).
Regulation 2(1) approved school: revoked, on 1 August 2011, by of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) colouring substance: revoked, on 1 August 2011, by -
of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) designated prescriber nurse: revoked, on 1 October 2005, by
of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 2(1) Dispensary Assistant's Certificate: revoked, on 1 August
2011, by of the Medicines Amendment Regulations 2011
(SR 2011/245).
Regulation 2(1) dispensary technician: substituted, on 1 August 2011, by
of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) general sale medicine: inserted, on 1 August 2011, -
of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) Pharmacy Council: inserted, on 1 August 2011, of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy graduate: substituted, on 1 August 2011, by -
of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy student: substituted, on 1 August 2011, -
of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy technician: substituted, on 1 August 2011, by -
of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy technician student: inserted, on 19 December
2002, by of the Medicines Amendment Regulations (No 2)
2002 (SR 2002/374).
Regulation 2(1) registered midwife: substituted, on 18 September 2004, by
of the Health Practitioners Competence Assurance Act 2003
(2003 No 48).
Reprinted as at1 December 2011 Medicines Regulations 1984
Regulation 2(1) safety container paragraph (b): amended, on 1 January
1995, by regulation 2 of the Medicines Regulations 1984, Amendment No 6
(SR 1994/299).
Regulation 2(1) student: added, on 19 December 2002, by of
the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Classification of medicines
Classification of medicines
All medicines and classes of medicines specified ofSchedule 1 are hereby declared to be prescription medicines.
(1A) [Revoked](1B) [Revoked](2) All medicines and classes of medicines specified ofSchedule 1 are hereby declared to be restricted medicines.
Subject to subclause (4), all medicines and classes ofmedicines specified of Schedule 1 are hereby de-clared to be pharmacy-only medicines.
Nothing in subclause (3) shall apply to a remedy that is, and isdescribed as, homoeopathic.
Regulation 3(1A): revoked, on 1 November 2005, by of theMedicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR2005/266).
Regulation 3(1B): revoked, on 1 November 2005, by of theMedicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR2005/266).
Standards for medicines, related products, medical
devices, cosmetics, and surgical dressings
Any medicine or related product, other than a medicine or re-lated product for which a standard is otherwise prescribed inthese regulations, shall, where it is described as conformingto a monograph in a specified publication, conform to the de-scription and tests set out in that publication for that medicineor related product.
Medicines Regulations 1984
Every medicine, related product, or cosmetic used or repre-sented as suitable for application into the eye shall conform tothe tests for sterility set out in a specified publication.
Every medicine, related product, or cosmetic that is a dust-ing powder for use on the skin of a baby, or on any inflamed,abraded, or broken skin, shall be free of pathogenic organisms.
No medicine, related product, cosmetic, or dentifrice intendedfor sale shall contain or have attached to it or enclosed with itany extraneous thing that is harmful, dangerous, or offensive.
A surgical dressing that is described as conforming to a mono-graph in a specified publication shall conform to the descrip-tion and tests set out in that publication for that surgical dress-ing.
A medical device that is described as conforming to a particu-lar description shall conform to that description.
Pharmacist may dilute medicine in particular case
Where any liquid medicine in respect of which a standard is
prescribed by any of the provisions of these regulations is to
be supplied by a pharmacist pursuant to a prescription issued
for a particular patient, the pharmacist may add a compatible
diluent to the medicine if he is satisfied that—
(a)
such dilution is necessary to adjust the dose to a quantityeasily measurable by the patient or by any other personon behalf of the patient; and the addition of that diluent will not affect injuriously thecomposition of the medicine.
Regulation 6: revoked, on 1 August 2011, of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Advertisements not to claim official approval
No advertisement relating to any medicine, related product, or
medical device shall contain a statement to the effect that an
Reprinted as at1 December 2011 Medicines Regulations 1984
advisory or technical committee established under ofthe Act, or any member of such a committee, or any officer inthe service of the Government, has approved, or has refrainedfrom disapproving, the advertisement or any of the claims orstatements made in it.
Advertisements for medicines
Every advertisement for a prescription medicine must in-clude—(a) the words "Prescription medicine" or words of a similarmeaning; and the name of each active ingredient; and the appropriate quantitative particulars of each activeingredient; and a statement of the purpose for which the medicine isintended to be used; and a statement that the medicine has risks and benefits; and a statement about how to find further information on therisks and benefits of the medicine.
Every advertisement for a restricted medicine must include—(a) the following statements, or statements with a similarmeaning:(i) "Available only from your pharmacist."; and "If symptoms persist, see your doctor or healthprofessional."; and "Use only as directed."; and the name of each active ingredient, or the followingstatement, or a statement with a similar meaning:"Always read the label."; and a statement of the purpose for which the medicine isintended to be used; and any warning statement that may be required by guide-lines issued from time to time by the Ministry of Health.
Every advertisement for a pharmacy-only medicine or a gen-eral sale medicine must include—(a) the following statements, or statements with a similarmeaning:(i) "If symptoms persist, see your doctor or healthprofessional."; and Medicines Regulations 1984
"Use only as directed."; and the name of each active ingredient, or the followingstatement, or a statement with a similar meaning:"Always read the label."; and a statement of the purpose for which the medicine isintended to be used; and any warning statement that may be required by guide-lines issued from time to time by the Ministry of Health.
Every advertisement for a medicine to be supplied by mailorder, direct marketing, or via the Internet must—(a) include the name of each active ingredient; and include the appropriate quantitative particulars of eachactive ingredient; and comply with the following, to the extent they are applic-able:(i) subclause (1)(a), and (d) to (f): subclause (2)(a), (c), and (d): subclause (3)(a), (c), and (d).
A statement required by this regulation must be—(a) clearly printed; or clearly spoken.
A statement that is required by this regulation may be bothclearly printed and clearly spoken.
This regulation does not apply to—(a) an advertisement for a medicine that does not refer to atherapeutic purpose: an advertisement (not being an advertisement of thekind described in subclause (4)) that is—(i) located at the point of sale; and positioned immediately above, below, or next tothe medicine to which it relates: price lists.
An advertisement for a prescription, macy-only, or general sale medicine that is subsequentlyreclassified must be treated as compliant with this regulationif— Reprinted as at1 December 2011 Medicines Regulations 1984
the advertisement was compliant with every applicablerequirement in this regulation immediately before themedicine was reclassified; and not more than 3 months have elapsed since the medicinewas reclassified.
In any proceedings for an offence against of the Act,it is for the defendant to prove that subclause (8) applies.
Regulation 8: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Advertisements for related products
Every advertisement for a related product, other than a label ora price list, shall include a statement of the uses of the relatedproduct.
Every advertisement that refers to an active ingredient of arelated product by name shall state the appropriate designationof the ingredient.
Advertisements for medical devices
Every advertisement for a medical device, other than a label
or a price list, shall include, where appropriate, the following:
(a)
an accurate description of the medical device: a statement of the uses of the medical device: a statement of the appropriate precautions to be taken inthe use of the medical device: a statement of any contraindications to the use of themedical device.
Advertisements intended for health professions
This regulation applies—(a) to advertisements intended for members of the medical,dental, pharmaceutical, and related professions; and in addition to the requirements and(but ).
Every advertisement for a medicine must—(a) the classification of the medicine; and the name of each active ingredient; and Medicines Regulations 1984
the appropriate quantitative particulars of eachactive ingredient; and a statement of the purpose for which the medicineis intended to be used; and a statement of the appropriate precautions to betaken in the use of the medicine; and information on the effectiveness and limitationsof the medicine; and (vii) a statement of any restriction imposed on distri- (viii) the dosage regime and mode of administration, or method of use, of the medicine; and a statement of any contraindications to the use ofthe medicine; and information on the likely potentiating effects andinteractions with other substances, medicines, orenvironmental influences; and a statement of the known or likely poisonous ef-fects of, or adverse reactions to, the medicine; but not include—(i) a statement (based on the citation of a report)relating to the effectiveness or safety of themedicine that omits relevant parts of the report,or quotes from the report in such a way thatanother meaning to that intended by the report isconveyed; or data, previously considered valid, but made ob-solete or false by subsequent findings; or a statement of the use of the medicine, or thedosage of the medicine, that contravenes anycondition of a consent given ,of the Act.
Nothing in subclause (2)(a)(iii) or (vi) to (xi) applies to anadvertisement that—(a) is intended to provide a practitioner with details of—(i) a major therapeutic indication of a medicine; or Reprinted as at1 December 2011 Medicines Regulations 1984
the listing of a medicine in the pharmaceuticalschedule (within the meaning ofthe New Zealand Public Health and DisabilityAct 2000); or a new or changed strength of a medicine; and does not enable the practitioner to reach a prescribingdecision.
Every advertisement for a related product or medical devicemust include—(a) a statement of any restriction imposed on distribution;and the dosage regime and mode of administration, ormethod of use, of the related product or medical device;and information on the effectiveness and limitations of therelated product or medical device.
Regulation 11: substituted, on 1 August 2011, of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Medicines, related products, and medical devices not to
be sold unless properly labelled
No person shall sell any medicine or related product in a con-tainer if the container—(a) does not bear a label containing all the particulars re-quired by these regulations to be on a label relating tosuch a container; or bears a label containing anything that is prohibited bythese regulations from appearing on a label relating tosuch a container; or bears a label containing any particulars that are not inthe position, manner, and style required by these regu-lations in respect of a label relating to such a container.
No person shall sell a package containing a single container ofany medicine or related product unless that package is labelledin a manner similar to that in which the container is labelled.
Medicines Regulations 1984
No person shall sell any medicine in a poison bottle bearingany label that obscures any flutings, ribs, nettings, points, em-bossed words, or similar markings on the bottle.
No person shall sell any medical device that does not bear thename of the manufacturer of the medical device or the nameof the manufacturer's distributor in New Zealand.
Notwithstanding anything in the foregoing provisions of thisregulation, the Director-General may, by notice in writing tothe manufacturer or importer of any medicine, exempt fromthe labelling requirements of these regulations the sale of thatmedicine in a container of a specified type.
Labelling of medicines
Every container of a medicine must, unless otherwise providedby these regulations, bear a label containing the following in-formation:(a) the trade name of the medicine or, if there is no tradename, the appropriate designation of the medicine: the name of each active ingredient: the appropriate quantitative particulars of each activeingredient: a description of the medicine, including dose form,or presentation, that indicates the true nature of themedicine: a statement of the net weight or volume or number ofthe contents of the container, as the case may require: in the case of a prescription medicine,—(i) the words "PRESCRIPTION MEDICINE" orwords of a similar meaning; or MEDICINE" or words of a similar meaning; or the acronym "POM": in the case of a restricted medicine,—(i) the words "RESTRICTED MEDICINE"; or in the case of a pharmacy-only medicine,—(i) the words "PHARMACY-ONLY MEDICINE"or words of a similar meaning; or Reprinted as at1 December 2011 Medicines Regulations 1984
the words "PHARMACY MEDICINE" or wordsof a similar meaning: any warning statement required by these regulations forthe medicine: in the case of a medicine other than a prescriptionmedicine, a statement of the purpose for which themedicine is intended to be used: in the case of a medicine sold, or intended for sale, forexternal use,—(i) a statement of directions for use and frequency ofuse; and the words "Caution: not to be taken", or "For ex-ternal use only", or words of a similar meaning: in the case of a medicine sold, or intended for sale, forinternal use,—(i) the dose recommended; and the frequency of that dose: the words "Batch Number" or "Lot Number", or theword "Batch" or "Lot", or the letter "B" (either aloneor inside a circle) followed by the batch or lot numberof the medicine: the words "Use by" or "Use before", or words of asimilar meaning, followed by the expiry date (being inno case later than 5 years after the date of manufac-ture of the medicine) appropriate to the stability of themedicine: where appropriate, a statement of the recommendedstorage conditions: the name and address of—(i) the manufacturer or seller of the medicine; or the owner of the rights of manufacture; or the agent of any person who comes within sub-paragraph (i) or (ii).
For the purposes of subclause (1)(p),—(a) an address at a post office is not sufficient: the name and address of a person not ordinarily residentin New Zealand are not sufficient unless the medicine iswholly manufactured and packed outside New Zealand: Medicines Regulations 1984
in the case of a body corporate registered in NewZealand, the name of the town in which the bodycorporate has its registered office is sufficient.
In the case of a medicine intended for administration onlyin accordance with the directions of a practitioner, it is suf-ficient compliance with subclause (1)(l) to indicate the doseby a range if the container is accompanied by a more specificstatement relating to each usage.
In the case of a prescription medicine, compliance with therequirements of subclause (1)(k) or (l) is required only at thetime at which that medicine—(a) is sold by retail; or is supplied in circumstances corresponding to retailsale; or is supplied by way of gift or sample for the purpose ofpromoting a sale.
Subclause (1)(l) does not apply in the case of a medicine in-tended to be administered by or under the supervision of apractitioner, in circumstances where the dosage is to be de-pendent on concurrent skilled observation.
Every container of a medicine that is prepared for injectioninto the human body and that contains an antiseptic or preser-vative must be labelled with a statement of the nature andamount of the antiseptic or preservative.
Every container of a medicine that is a biochemical prepar-ation must, in addition to the other requirements in this regu-lation, bear a label containing the following:(a) a statement of the potency of the preparation; and a statement of the nature and amount of every antisepticor preservative (if any) used in the medicine.
Where it is impractical to put all of the information requiredby this regulation on a label because the container is too small,it is sufficient compliance with this regulation to print the in-formation required by subclause (1)(i), (j), and (o) on a separ-ate information sheet, in the same manner as that informationwould be required by these regulations to be printed on a label,and to supply that sheet to the customer with the medicine.
This regulation is subject to .
Reprinted as at1 December 2011 Medicines Regulations 1984
Regulation 13: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Labelling of related products
Every container of a related product must, unless otherwiseprovided by these regulations, bear a label containing the fol-lowing information:(a) the trade name of the related product or, if there is notrade name, the appropriate designation of the relatedproduct: the name of each active ingredient: the appropriate quantitative particulars of each activeingredient: a description of the related product that indicates thetrue nature of the related product: a statement of the net weight or volume or number ofthe contents of the container, as the case may require: any warning statement required by these regulations forthe related product: in the case of a related product sold, or intended for sale,for external use,—(i) a statement of directions for use and frequency ofuse; and the words "Caution: not to be taken", or "For ex-ternal use only", or words of a similar meaning: in the case of a related product sold, or intended for sale,for internal use,—(i) the dose recommended; and the frequency of that dose: the words "Batch Number" or "Lot Number", or theword "Batch" or "Lot", or the letter "B" (either aloneor inside a circle) followed by the batch or lot numberof the related product: where appropriate, an expiry date: the name and address of—(i) the manufacturer or seller of the related product;or the owner of the rights of manufacture; or Medicines Regulations 1984
the agent of any person who comes within sub-paragraph (i) or (ii).
For the purposes of subclause (1)(k),—(a) an address at a post office is not sufficient: the name and address of a person not ordinarily resi-dent in New Zealand are not sufficient unless the re-lated product is wholly manufactured and packed out-side New Zealand: in the case of a body corporate registered in NewZealand, the name of the town in which the bodycorporate has its registered office is sufficient.
Regulation 14: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Exemptions from regulations 13 and 14
Nothing in (except subclause (1)(a), (b), (c), (m),and (n)) and nothing (except subclause (1)(a),(b), (c), (i), and (j)) applies to—(a) a container that—(i) contains a single dose of a medicine or relatedproduct; and is made of sheet material; and is not attached to another container; and is contained in a package that complies with(as the case requires); and is not intended for sale other than in that package: a container that—(i) contains a single dose of a medicine or relatedproduct; and is not made of sheet material; and has a volume of 20 millilitres or less; and is contained in a package that complies with(as the case requires); and is not intended for sale other than in that package: a container (other than an aerosol container) that—(i) contains a medicine or related product that is agas; and Reprinted as at1 December 2011 Medicines Regulations 1984
is of a kind commonly used for storing or trans-porting gases in compressed, liquefied, or dis-solved form; and has a capacity not exceeding 250 litres water cap-acity: a container of a remedy that is, or is described as, home-opathic.
Nothing or applies to a strip of containersthat—(a) is made of sheet material; and bears the information required by—(i) (as the case requires) at least once on thestrip; and or (as the case requires)—(A) at least once in relation to every 2 contain-ers, if the containers are easily detachedfrom the strip; and at least once on the strip in any other case;and is contained in a package that complies with or (as the case requires); and is not intended for sale other than in that package.
In this regulation, strip of containers means a series of con-
tainers that each contain a single dose of a medicine or related
product and that together form a strip.
Nothing applies to a pre-scription medicine, restricted medicine, or pharmacy-onlymedicine, held for sale by a manufacturer or wholesaler, forthe period of 3 months immediately following the date onwhich it becomes a prescription medicine, restricted medicine,or pharmacy-only medicine (as the case may be) if, at thatdate, the medicine was part of the existing stock-in-trade inNew Zealand of the manufacturer or wholesaler.
Nothing applies to a pre-scription medicine, restricted medicine, or pharmacy-onlymedicine, held for sale by a retailer, for the period of 6months immediately following the date on which it becomes a Medicines Regulations 1984
prescription medicine, restricted medicine, or pharmacy-onlymedicine (as the case may be) if, at that date, the medicinewas part of the existing stock-in-trade in New Zealand of theretailer.
For the purposes of subclauses (4) and (5), any goods pur-chased before the date on which a substance becomes aprescription medicine, restricted medicine, or pharmacy-onlymedicine (as the case may be) for importation into NewZealand are deemed to be part of the purchaser's stock-in-tradein New Zealand.
In any proceedings for an offence of the Actin respect of any container that does not comply the onus is on the defendant to provethat the relevant paragraph does not apply by virtue of sub-clause (4) or (5) of this regulation.
Regulation 15: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Principal display panel
The principal display panel of the label of a medicine mustcontain—(a) the information required and the information required by ,but only if the medicine contains 3 or fewer active in-gredients.
Subclause (1) is subject to The principal display panel of the label of a related productmust contain—(a) the information required and the information required by ,but only if the related product contains 3 or fewer activeingredients.
Nothing in subclause (1) or (3) prevents the inclusion in theprincipal display panel of any other matters required by theseregulations to appear on a label of any medicine or relatedproduct.
Subclause (4) is subject to Reprinted as at1 December 2011 Medicines Regulations 1984
Regulation 16: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Form and manner of labelling
Subject to subclause (4), every label that is required by theseregulations to be borne on a container shall—(a) be conspicuously written in English and, for each state-ment separately required, be in a colour or colours con-trasting strongly with the statement's background; and be legibly and durably marked either on the material ofthe container or on material firmly and securely attachedto the container; and be of such nature and material that it will not fade tothe extent of becoming illegible, or become detached,by the influence of—(i) atmospheric humidity or dryness; or normal atmospheric temperatures; or recommended storage temperatures; or the contents of the container; and be of such a nature and in such a position that it will notreadily be defaced in the course of normal handling anduse; and be in such a position that it is not damaged, defaced,destroyed, or removed when the container is opened;and not be obscured by any other label, folder, or pamphlet;and The lettering of the words required by these regulations shallbe clear, distinct, and legible, with no decoration, embellish-ment, or distortion that could interfere with the legibility of thewords.
Every label that is required by these regulations to appear ona container shall, if the medicine or related product is soldotherwise than in a container, appear on the medicine or relatedproduct.
Medicines Regulations 1984
It shall be sufficient compliance with subclause (1) if the par-ticulars required by paragraphs (d) and (e) are embossed conspicuously on the container of the medicine.
Regulation 17(1)(a): amended, on 30 November 2000, by of theMedicines Amendment Regulations 2000 (SR 2000/220).
Regulation 17(1)(g): revoked, on 30 November 2000, of theMedicines Amendment Regulations 2000 (SR 2000/220).
Size of letters
A minimum size of lettering used on labels that is prescribedby these regulations refers to the height of capital letters, orlower case letters with an ascender or descender, in the type-face used.
Subject to subclause (6) and except as otherwise expressly per-mitted by any of the provisions of these regulations, the letter-ing of words required by these regulations to appear on labelsshall be not less than 1.5 millimetres in height.
Where words are required by these regulations to appear onlabels in letters of a specified size, and the container to belabelled is so small as to prevent the use of letters of that size,letters of a smaller size may be used if they are of the largestsize practicable in the circumstances and are in any event nosmaller than 0.75 millimetres.
Regulation 18(1): substituted, on 30 November 2000, by of theMedicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(2): revoked, on 30 November 2000, of theMedicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(3): revoked, on 30 November 2000, of theMedicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(4): revoked, on 30 November 2000, of theMedicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(7): revoked, on 30 November 2000, of theMedicines Amendment Regulations 2000 (SR 2000/220).
Reprinted as at1 December 2011 Medicines Regulations 1984
Labelling of prescription medicines, restricted medicines,
and pharmacy-only medicines
Where a label on a container is required by these regulations
to bear—
(a)
the words "PRESCRIPTION MEDICINE" or words ofa similar meaning; or the words "PRESCRIPTION ONLY MEDICINE" orwords of a similar meaning; or the acronym "POM"; or the words "RESTRICTED MEDICINE"; or the words "PHARMACIST ONLY MEDICINE"; or the words "PHARMACY-ONLY MEDICINE" orwords of a similar meaning; or the words "PHARMACY MEDICINE" or words of asimilar meaning,— the words or acronym, as the case may require, shall be placedprominently and legibly on the label.
Regulation 19: substituted, on 1 January 1995, by regulation 5 of the MedicinesRegulations 1984, Amendment No 6 (SR 1994/299).
Regulation 19: amended, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Regulation 20: revoked, on 1 August 2011, of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Labels on containers of medicines or related products
containing vitamins
The quantitative declaration of every vitamin in any medicine
or related product shall be expressed in milligrams or micro-
grams.
Warning statements for medicines and related products
Every container of a medicine or related product must includeon its label any warning statement that may be required byguidelines issued from time to time by the Ministry of Health.
Medicines Regulations 1984
A warning statement is additional to any other statement orinformation that is required by these regulations to be shownon a label.
Subclause (1) is subject to Regulation 22: substituted, on 1 August 2011, of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Labels on containers of medicines sold by authorised
prescribers or pharmacists
It shall not be necessary to comply with the requirements of
or in respect of
any label on a container of a medicine that is packed, supplied,
or sold by an authorised prescriber or a pharmacist with ref-
erence to the needs of a particular patient or (as the case may
be) a particular customer, if the label contains the following:
(a)
the name of, or a description of the nature of, the con-tents; and the name of the patient; and the name and address of the seller; and in the case of a medicine for internal use, the dose andfrequency of dose; and in the case of a medicine for external use, a statementof the directions for use and frequency of use, and oneor other of the following statements, or words of similarmeaning:"Caution: Not To Be Taken", or "For External UseOnly"; and a unique identifying number or code for the prescriptionor record of supply; and the date on which the medicine was packed, sold, orsupplied.
Regulation 23 heading: substituted, on 11 October 2001, by ofthe Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 23 heading: amended, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 23: amended, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23: amended, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Reprinted as at1 December 2011 Medicines Regulations 1984
Regulation 23(a): substituted, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23(e): amended, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23(f): added, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23(g): added, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Labels on containers of hair dyes
This regulation applies to labels on containers of related prod-ucts and cosmetics that are intended for dyeing hair and consistof or contain—(a) phenylenediamine, or its salts; or toluenediamine, or its salts; or other aromatic amines intended for dyeing hair, or theirsalts; or any derivative of any substance to which paragraph (a)or paragraph (b) or paragraph (c) applies.
Every label to which this regulation applies shall include thefollowing:(a) the name or description of the dye substance: the name and address of the manufacturer or (as the casemay be) the packer or seller of the related product orcosmetic: directions for the use of the related product or cosmetic: one or other of the following statements, or words ofsimilar meaning:"Not To Be Taken", or "For External Use Only": the following statement, or words of similar meaning:"May cause serious inflammation of the skin. Do notuse on eyelashes".
No written, pictorial, or other descriptive matter appearing onor attached to or supplied or displayed with any medicine ormedical device shall include any comment on, reference to, orexplanation of any statement or label required by these regu-lations to be borne on any medicine or medical device if that Medicines Regulations 1984
comment, reference, or explanation either directly or by impli-cation contradicts, qualifies, or modifies that statement or thecontents of that label.
No written, pictorial, or other descriptive matter supplied ordisplayed with any medicine or medical device shall includeany false or misleading statement, word, brand, picture, ormark purporting to indicate the nature, suitability, quantity,quality, strength, purity, composition, weight, origin, age, ef-fects, or proportion of the medicine or medical device or anyingredients of the medicine or components of the medical de-vice.
Manufacture, packing, storage, and
Persons handling medicines, related products, and
cosmetics
Every person who—(a) is engaged or employed in the manufacture, packing,labelling, storage, or supply of any medicine, relatedproduct, or cosmetic for sale; and in the course of his engagement or employment in thatactivity comes into direct contact with—(i) any medicine, related product, or cosmetic; or the interior part of any container containing anymedicine, related product, or cosmetic; or a wrapper for any medicine, related product, orcosmetic— shall, at all times while so engaged or employed, maintain hisclothing and his person in a state of cleanliness.
No person who is engaged or employed in the sale of anymedicine, related product, or cosmetic, or in the manufacture,packing, labelling, storage, or supply of any medicine, relatedproduct, or cosmetic for sale, shall do any act or make any de-fault or omission whereby that medicine, related product, orcosmetic becomes or is liable to become contaminated, pol-luted, or tainted.
Reprinted as at1 December 2011 Medicines Regulations 1984
Infected persons
No person who is suffering from a communicable disease
(within the meaning of or is a carrier
(within the meaning of that Act), or is suffering from a condi-
tion causing a discharge of pus or exudate, shall engage or be
employed in the sale, or the manufacture, packing, labelling,
storage, or supply, for sale, of—
(a)
any medicine, related product, or cosmetic; or any material or article used or likely to be used as awrapper or container for any medicine, related product,or cosmetic.
Persons in contact with infected persons
The Medical Officer of Health may, by notice in writing servedon a person who has been in recent contact with any personto applies, prohibit the person so servedfrom engaging or being employed in the sale of any medicine,related product, or cosmetic, or the manufacture, packing, la-belling, storage, or supply of any medicine, related product, orcosmetic for sale.
Where, in the opinion of the Medical Officer of Health, thereis no longer any risk of any medicine, related product, or cos-metic becoming infected by a person on whom any such noticehas been served, the Medical Officer of Health shall revoke thenotice, and shall notify the person in writing of the revocation.
No person shall—(a) engage or undertake employment in any activity incontravention of a notice served on him under thisregulation; or knowingly employ any other person in contravention ofa notice served on that other person under this regula-tion.
Places of manufacture, storage, and sale
No person shall use any place or permit any place to be used for
or in connection with the sale of any medicine, related prod-
uct, or cosmetic, or the manufacture, storage, or packing of
any medicine, related product, or cosmetic for sale, unless the
place complies with the following requirements:
Medicines Regulations 1984
the place shall be kept adequately lighted by daylight orartificial light, as the circumstances require, at all timeswhen any work is being carried out there: the place shall be kept appropriately ventilated at alltimes while any medicine, related product, or cosmetic,or any container or material for the packing of anymedicine, related product, or cosmetic, is present there: if a waste liquid is produced there, the place shall beprovided with a means of drainage that is sufficient forthe removal of the waste liquid, and that is kept in good,clean, working order and condition: the place shall be kept, so far as is practicable, clean andfree from foul odours and free from dust and creatureslikely to contaminate the medicine, related product, orcosmetic: the walls, floors, ceilings, and roofs shall be properlyconstructed and kept in good repair, and shall be easyto clean: the place shall not be used for any purpose (otherthan the sale of any medicine, related product, orcosmetic, or the manufacture, storage, or packing ofany medicine, related product, or cosmetic for sale)that might affect the quality of the medicine, relatedproduct, or cosmetic: the place shall be provided with sinks and other sanitaryfittings reasonably necessary for cleansing appliancesused there, and all such sinks and other sanitary fittingsshall be maintained in good, clean working order andcondition: the place shall be provided with an adequate supply ofhot and cold water, and soap or other detergent: the place shall be provided adequately with wash basinsand toilets for the use of persons engaged or employedin or about the premises, and all such wash basins andtoilets shall be maintained in good, clean working orderand condition, and shall be provided with an adequatesupply of hot and cold water, soap or other detergent,nail brushes, and towels or other drying equipment.
Reprinted as at1 December 2011 Medicines Regulations 1984
Dwellinghouses prohibited for manufacture and packing
No person shall use any dwellinghouse, or permit any
dwellinghouse to be used, for or in connection with the
manufacture or packing of any medicine, related product, or
cosmetic for sale if the use of the dwellinghouse is likely to
result in the contamination of the medicine, related product,
or cosmetic, or to affect injuriously its cleanliness.
Powers of Medical Officer of Health in respect of premises
This regulation shall apply to premises that are, in the opinionof the Medical Officer of Health, by reason of their construc-tion or disrepair, or by reason of the use or character of anyneighbouring premises, in such a condition that any medicine,related product, or cosmetic in the first premises may be ex-posed to contamination or taint, or may deteriorate or becomedirty.
Subject to subclause (6), the Medical Officer of Health mayserve a notice in writing on any owner or occupier of anypremises to which this regulation applies, prohibiting the useof the premises for or in connection with the manufacture, stor-age, or packing of any medicine, related product, or cosmeticfor sale.
Every such notice shall—(a) specify the premises to which it relates: state the reason for the prohibition: specify a date on which the prohibition is to come intoforce.
Subject to subclause (6), where in the opinion of the MedicalOfficer of Health the reason for which any such notice wasserved has ceased to exist, he shall revoke the notice, and shallnotify in writing the owner or occupier of the premises con-cerned, and every other person on whom a copy of the noticehas been served, of the revocation.
While any such notice remains in force,—(a) no person on whom it has been served shall use or per-mit the use of the premises specified in the notice for orin connection with the manufacture, storage, or packingof any medicine, related product, or cosmetic for sale;and Medicines Regulations 1984
no person on whom a copy of the notice has been servedor who knows the contents of the notice shall use thosepremises for any such purpose.
No notice shall be served by a Medical Officer of Health pur-suant to subclause (2) or subclause (4) unless approval to servethe notice has first been obtained from the Director-General.
Storage of medicines, etc
Every person in possession or control of any medicine, relatedproduct, or cosmetic for sale, or of any container or applianceused for or in connection with the sale of any medicine, relatedproduct, or cosmetic, or the manufacture, storage, or packingof any medicine, related product, or cosmetic for sale, shall atall times—(a) keep the medicine, related product, cosmetic, container,or appliance clean and free from contamination bymoisture, foul odours, or dust; and protect the medicine, related product, cosmetic, con-tainer, or appliance from access by creatures likely tocontaminate it.
Every person in possession of any medicine, related product,or cosmetic for sale shall at all times store and keep it packed insuch manner as to minimise its deterioration, and shall complywith all requirements for storage stated on the label or con-tained in a specified publication in respect of that medicine,related product, or cosmetic.
Construction and use of containers, etc
No person shall use, or permit to be used, any container, ap-pliance, or vehicle for or in connection with the manufacture,storage, packing, or supply of any medicine, related product,or cosmetic for sale unless that container, appliance, or vehicleis constructed of such material and in such manner as to allowfor easy cleaning, and is kept clean.
No person shall use, or permit to be used, in the supply ofany medicine, related product, or cosmetic for sale any con-tainer, appliance, or vehicle that is also used for the carriageof any matter that endangers or could endanger the cleanliness Reprinted as at1 December 2011 Medicines Regulations 1984
or freedom from contamination of the medicine, related prod-uct, or cosmetic.
No person shall use, or permit to be used, for the manufacture,storage, or packing of any medicine, related product, or cos-metic for sale, any container that has been used for any purposethat may contaminate or taint the medicine, related product, orcosmetic, unless the container has been thoroughly cleaned.
Exposure to toxic substances prohibited
Except as otherwise provided in these regulations, no per-
son shall, in the course of the manufacture, storage, packing,
or supply of any medicine, related product, or cosmetic for
sale, keep, carry, spread, or use, or permit to be kept, carried,
spread, or used, any toxic or noxious substance so as to expose
the medicine, related product, or cosmetic to the risk of con-
tamination by that substance at any time.
Containers for medicines, related products, and cosmetics
A person must not pack, store, or sell a prescription medicine,restricted medicine, or pharmacy-only medicine in a containermade of paper; but nothing in this subclause prevents the per-son from packing, storing, or selling the medicine in a con-tainer made of cardboard.
No person shall use, or permit to be used, in the storage, pack-ing, or supply of any medicine, related product, or cosmeticfor sale, a container that yields, or could yield, to its contentsa toxic, injurious, or tainting substance.
Every container used in the packing of a medicine and madeof glass or plastic shall comply with the tests for that type ofcontainer (if any) specified in the United States Pharmacopeia.
Every container used in the packing of a medicine and madeof metal shall be impermeable to moisture.
Every container used in the packing of a medicine and madeof metal or plastic shall be made of a material that will notadversely react with the contents of the container.
Except as provided in subclause (8), no person shall store,pack, or sell in a container of a capacity of not less than 15 Medicines Regulations 1984
millilitres and not more than 2.5 litres any medicine, relatedproduct, or cosmetic that—(a) is in liquid form; and is intended for external use; and has poisonous properties,— unless the container is a poison bottle.
It shall not be necessary to pack in a poison bottle anymedicine, related product, or cosmetic to which subclause (7)applies if that medicine, related product, or cosmetic is—(a) supplied to or held for use in educational establish-ments, or in scientific or industrial laboratories; or supplied to or held by analysts, pharmacists, authorisedprescribers, or veterinary surgeons; or supplied to or held by persons engaged as suppliers toany of the establishments, laboratories, or classes ofpersons mentioned in paragraphs (a) and (b); or a hair dye to applies.
No person shall have in his possession or charge (whetherfor the purposes of sale or otherwise) in an open container,any medicine, related product, or cosmetic that has poisonousproperties, except while the container is being filled or themedicine, related product, or cosmetic in the container is be-ing used.
No person in possession or charge of any medicine, relatedproduct, or cosmetic shall keep it, whether temporarily or per-manently, in any bottle, jar, can, tinplate container, culinaryutensil, or other container of a type that—(a) bears any brand, mark, statement, or picture that indi-cates the presence in the container of any food, drink,or condiment; or is of a distinctive type in which any food, drink, orcondiment, has been commonly or is being currentlysold, whether or not the container bears any brand,mark, statement, or picture.
Regulation 35(1): substituted, on 24 July 2006, of the MedicinesAmendment Regulations 2006 (SR 2006/158).
Regulation 35(2): revoked, on 24 July 2006, of the MedicinesAmendment Regulations 2006 (SR 2006/158).
Regulation 35(8)(b): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Reprinted as at1 December 2011 Medicines Regulations 1984
Storage to be separate
No person shall store or keep for ready use any medicine, re-
lated product, or cosmetic in such manner that a food or drink
may be contaminated by the escape or leakage of the medicine,
related product, or cosmetic, or by the release of vapours from
the medicine, related product, or cosmetic.
No person shall sell any tablet, or other single item in solidform that is intended to be taken orally, being or comprisinga medicine or belonging to a class of medicines to which thisregulation applies, unless the tablet or item is enclosed in asafety container.
Subclause (1) shall not apply—(a) where an authorised prescriber directs, either on the pre-scription or otherwise,—(i) that a medicine is not to be sold enclosed in asafety container; or that he or she does not wish the name of themedicine to appear on the label; or where a pharmacist is of the opinion that, because of theage or infirmity of a particular person, a medicine to beused by that person should not be enclosed in a safetycontainer; or in the case of capsules, pills, powder, or other solid doseforms, prepared in a pharmacy with reference to theparticular needs of a patient.
This regulation applies to the following medicines:aspirin, and its salts; and medicines containing aspirin or itssalts:iron, in medicines for human use containing more than 24 mil-ligrams of elemental iron per dose:paracetamol; and medicines containing paracetamol.
This regulation applies to the following classes of medicines:barbiturates: Medicines Regulations 1984
phenothiazine, and derivatives of phenothiazine and theirsalts, except dimethothiazine, methdilazine, promethazine,and trimeprazine, and their salts and molecular compounds:tricyclic, tetracyclic, and analogous antidepressants.
Regulation 37(2)(a): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 37(2)(a)(ii): amended, on 11 October 2001, ofthe Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 37(3): revoked, on 1 August 2011, of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Importation and transport
Every medicine imported into, or packed or consigned fortransport in, New Zealand shall be securely packed in a con-tainer that is sufficiently strong to withstand, and to protect thecontents from damage arising in, the ordinary course of trans-port.
No person shall import into, or transport or cause to be trans-ported in, New Zealand any medicine that is not packed incompliance with subclause (1).
Every related product packed or consigned for transport inNew Zealand shall be securely packed in a container that issufficiently strong to withstand, and to protect the contentsfrom damage arising in, the ordinary course of transport.
No person shall transport or cause to be transported in NewZealand any related product that is not packed in compliancewith subclause (3).
Conditions under which authorised prescribers and
veterinarians may prescribe prescription medicines
An authorised prescriber (including a designated prescriber)may only prescribe a prescription medicine if the authorisedprescriber—(a) is prescribing the prescription medicine— Reprinted as at1 December 2011 Medicines Regulations 1984
for the treatment of a patient under the authorisedprescriber's care; and within, and in accordance with all conditions (ifany) stated in, the authorised prescriber's scopeof practice, as determined by an authorisationgranted of the Health Practition-ers Competence Assurance Act 2003 by the au-thority responsible for the registration of the au-thorised prescriber; and is not prohibited by a notice under of theAct from prescribing that prescription medicine or anyprescription medicines of a class or description that in-cludes that prescription medicine.
An authorised prescriber who is a designated prescriber mayonly prescribe a prescription medicine if—(a) the prescription medicine is of a class or description thatthe designated prescriber is authorised to prescribe byregulations made under the Act; and the requirements specified in or imposed under thoseregulations are satisfied.
A veterinarian may only prescribe a prescription medicine thatis for the treatment of an animal under the veterinarian's care.
Subclause (1) does not apply to an authorised prescriber whois acting in the course of his or her employment by the Crown.
Regulation 39: substituted, on 1 December 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
39A Limit on period of supply of prescription medicines
(1)
An authorised prescriber may not on any occasion prescribefor any patient a quantity of any prescription medicine thatexceeds—(a) 6 months' supply in the case of an oral contraceptive; or 3 months' supply in any other case.
However, the Director-General may, at his or her discretion,authorise—(a) an authorised prescriber to prescribe for any patient, orany specified class or classes of patients, a quantity ofa prescription medicine exceeding the period of supplyin subclause (1)(a) or (b): Medicines Regulations 1984
a class of authorised prescribers to prescribe for anypatient, or any specified class or classes of patients,a quantity of a prescription medicine exceeding theperiod of supply in subclause (1)(a) or (b).
Regulation 39A: inserted, on 1 December 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Prescriptions to comply with regulations
Except as provided every authorised pre-scriber or veterinarian who issues a prescription to a personmust comply with .
Subclause (1) applies to a prescription for any medicine(whether a prescription medicine or not).
Subclause (2) does not prevent the sale by retail, or the supplyin circumstances corresponding to retail sale, or the dispens-ing, of a medicine (other than a prescription medicine) withouta prescription.
Regulation 40: substituted, on 11 October 2001, by of theMedicines Amendment Regulations 2001 (SR 2001/232).
Regulation 40(1): amended, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 40(1): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
40A Urgently required prescriptions of prescription medicines
may be communicated orally if later confirmed in writing
Where an authorised prescriber or veterinarian finds it neces-sary to do so, he or she may communicate orally to a pharma-cist to whom he or she is known personally (whether in thepharmacist's presence or by speaking to the pharmacist on thetelephone) a prescription relating to a prescription medicinethat the authorised prescriber or veterinarian requires urgently.
Within 7 days after a communication made by an authorisedprescriber or veterinarian to a pharmacist under subclause (1),the authorised prescriber or veterinarian must forward to thepharmacist a written prescription confirming the oral commu-nication.
Regulation 40A: inserted, on 11 October 2001, of theMedicines Amendment Regulations 2001 (SR 2001/232).
Reprinted as at1 December 2011 Medicines Regulations 1984
Regulation 40A(1): amended, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 40A(1): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 40A(1): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 40A(2): amended, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 40A(2): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 40A(2): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Form of prescription
Every prescription given under these regulations shall—
(a)
be legibly and indelibly printed; and be signed personally by the prescriber with his usualsignature (not being a facsimile or other stamp), anddated; and set out the following information in relation to the pre-scriber:(i) the prescriber's full name; and the full street address of the prescriber's place ofwork or, in the absence of the prescriber havinga place of work, the postal address of the pre-scriber; and the prescriber's telephone number; and the surname, each given name, and the addressof the person for whose use the prescription isgiven; and in the case of a child under the age of 13 years,the date of birth of the child; and indicate by name the medicine and, where appropriate,the strength that is required to be dispensed; and indicate the total amount of medicine that may be soldor dispensed, or the total period of supply; and if the medicine is to be administered by injection, or byinsertion into any cavity of the body, or by swallowing,indicate the dose and frequency of dose; and Medicines Regulations 1984
if the medicine is for application externally, indicate themethod and frequency of use; and in the case of a prescription relating to the treatment ofan animal,—(i) set out the surname, each given name, and theaddress of the owner of the animal; and contain the following statement, or words of sim-ilar meaning:"Not for human use".
Regulation 41(c): substituted, on 1 December 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(d)(i): substituted, on 1 December 2011, by ofthe Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(f): substituted, on 1 December 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(i): revoked, on 1 December 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(j)(i): substituted, on 1 December 2011, by ofthe Medicines Amendment Regulations 2011 (SR 2011/245).
Dispensing of prescription medicines
Except as provided in subclause (2), no person other thanan authorised prescriber, veterinarian, pharmacist, pharmacygraduate, a pharmacy technician, a student, or dispensarytechnician may dispense a prescription medicine.
(1A) The following persons may not dispense prescription medicines unless under the direct personal supervision of apharmacist:(a) dispensary technicians: pharmacy graduates: pharmacy technicians: An agent or employee of a veterinarian may, in any particularcase, dispense any prescription medicine at the direction of theveterinarian for use in the treatment of any animal under thecare of the veterinarian.
Every person dispensing a prescription relating to a prescrip-tion medicine must comply with the following requirements: Reprinted as at1 December 2011 Medicines Regulations 1984
if the prescription has been communicated orally underthe prescription must not be dis-pensed on more than 1 occasion before the pharmacisthas received the written confirmation of the prescrip-tion, as required by regulation 40A(2): the following information must be recorded on the pre-scription:(i) the name and address of the proprietor of thebusiness at which the prescription is dispensed;and the date on which the prescription is dispensed;and the quantity of medicine dispensed; and a unique identifying number or code for the pre-scription: a prescription for a medicine other than an oral con-traceptive must not be dispensed on any occasion after6 months have elapsed from the date on which it wasprinted or, if given under , communi-cated orally: a prescription for a medicine that is an oral contra-ceptive must not be dispensed on any occasion after9 months have elapsed from the date on which it wasprinted or, if given under , communi-cated orally: every prescription must be retained for a period of 3years by the pharmacist on the premises on which it wasdispensed or at a place approved by the Medical Officerof Health and must be kept in an orderly and consecu-tive manner so as to be readily available for inspection.
If an authorised prescriber or a veterinarian refers in a pre-scription to a medicine by its trade mark or trade name, or byreference to the name of its manufacturer, a pharmacist maysupply an alternative brand of medicine, provided that—(a) the authorised prescriber or veterinarian has not markedthe prescription "No brand substitution permitted" orwith words of similar meaning; and Medicines Regulations 1984
the substituted brand contains the same active ingredi-ent or active ingredients, and no other active ingredi-ents; and the substituted brand is in the same dose form andstrength as the prescribed brand; and there is no clinical reason why the substituted brandshould not be supplied; and the pharmacist records the brand substitution on the pre-scription; and the pharmacist signs and dates the prescription; and the pharmacist informs the patient of the brand substi-tution.
This regulation is subject .
Regulation 42(1): substituted, on 11 October 2001, by of theMedicines Amendment Regulations 2001 (SR 2001/232).
Regulation 42(1): amended, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(1): amended, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 42(1): amended, on 19 December 2002, of theMedicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Regulation 42(1A): inserted, on 19 December 2002, by of theMedicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Regulation 42(2): amended, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(3): substituted, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(4): substituted, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(5): added, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Director-General may waive certain requirements
Despite the requirements and the Dir-ector-General may, at his or her discretion,—(a) authorise a form of prescription that does not complywith all or any of the requirements in , butthat is subject to any other requirements that he or shethinks fit; and authorise the dispensing of prescription medicines ina manner that does not comply with all or any of the Reprinted as at1 December 2011 Medicines Regulations 1984
requirements in , but that is subject to anyother requirements that he or she thinks fit.
A form of prescription that may be authorised under subclause(1)(a) includes, but is not limited to, an electronic form ofprescription.
Regulation 43: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Prescriptions for prescription medicines not required in
certain cases
A prescription medicine may be sold or dispensed otherwise
than under a prescription given by a practitioner, registered
midwife, veterinarian, or designated prescriber if it is sold to
or dispensed for—
(a)
a person licensed to sell the prescription medicine bywholesale; or a person obtaining the prescription medicine for use inany process of manufacture or trade not involving theresale of the medicine; or an analyst under the Act, or a person approved by theDirector-General and in charge of a laboratory main-tained for the purposes of research, study, or analysis;or a hospital care operator within the meaning of of the Health and Disability Services (Safety) Act2001; or a pharmacist in control of any pharmacy, or any dispen-sary in a hospital care institution within the meaningof of the Health and Disability Services(Safety) Act 2001; or an authorised prescriber or veterinarian; or a patient under his or her care by an authorised pre-scriber; or a patient under the care of an authorised prescriber, pro-vided that— Medicines Regulations 1984
the medicine is administered by a person whohas been instructed by the authorised prescriber(either verbally or in writing) to do so; and the person administering the medicine recordsthe administration in the patient's medicalrecord; and the authorised prescriber records the instructionunder subparagraph (i) in the patient's medicalrecord; or the master of a New Zealand ship within the meaningof the ,—(i) if the medicine is prescribed by rules of that Act; or at a time before the commencement of the firstrules made under of that Act, ifthe medicine is authorised or required by scalesissued under section 138 or section 239 of theShipping and Seamen Act 1952; or the master of a foreign ship within the meaning of the, if the law of the Statewhose flag the ship is entitled to fly requires the masterto carry the medicine; or a person for inclusion in an emergency medical kit keptor to be kept for use in any vessel to which paragraph (i)does not apply, and is so sold or dispensed pursuant toan order signed by a Medical Officer of Health; or the person in charge of an aircraft if the medicine isrequired to be carried on the aircraft as a condition ofthe issue of a certificate of airworthiness; or a person for inclusion in an emergency medical kit pur-suant to an order signed by a Medical Officer of Healthfor use in a place of a class approved by the Director-General; or a person who has previously been supplied with themedicine on the prescription of an authorised prescriberfor a particular condition, and is so sold or dispensed— Reprinted as at1 December 2011 Medicines Regulations 1984
by a pharmacist who is satisfied that the personrequires an emergency supply of the medicine forthat condition; and in an amount not exceeding the quantity reason-ably required by that person for a period of 72hours, or a minimum pack of a special containerfrom which it is not practicable to dispense alesser amount; or any person by a veterinarian for the treatment of an ani-mal under the care of the veterinarian; or a person or body authorised to distribute, or a personauthorised to administer, the prescription medicine inan approved immunisation programme.
Regulation 44 heading: amended, on 11 October 2001, ofthe Medicine Amendment Regulations 2001 (SR 2001/232).
Regulation 44: amended, on 30 November 2000, of theMedicines Amendment Regulations 2000 (SR 2000/220).
Regulation 44(d): substituted, on 1 October 2002, by of the Healthand Disability Services (Safety) Act 2001 (2001 No 93).
Regulation 44(e): substituted, on 1 October 2002, of the Healthand Disability Services (Safety) Act 2001 (2001 No 93).
Regulation 44(f): substituted, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(f): amended, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(fa): revoked, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(fb): revoked, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(g): substituted, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(ga): revoked, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(gb): revoked, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(h): substituted, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(ha): revoked, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(hb): revoked, on 1 October 2005, of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(i): substituted, on 30 November 2000, by of theMedicines Amendment Regulations 2000 (SR 2000/220).
Medicines Regulations 1984
Regulation 44(ia): inserted, on 30 November 2000, of theMedicines Amendment Regulations 2000 (SR 2000/220).
Regulation 44(m): amended, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(m): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(n): amended, on 1 August 2011, of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(n): amended, on 17 April 1992, by regulation 3(2) of theMedicines Regulations 1984, Amendment No 5 (SR 1992/43).
Regulation 44(o): added, on 17 April 1992, by regulation 3(1) of the MedicinesRegulations 1984, Amendment No 5 (SR 1992/43).
44A Administration of vaccines in approved immunisation
Any medical practitioner or other person who is authorisedby the Director-General or a Medical Officer of Health in ac-cordance with this regulation to administer, for the purposesof an approved immunisation programme, a vaccine that is aprescription medicine, may, in carrying out that immunisationprogramme, administer that prescription medicine otherwisethan pursuant to a prescription.
The Director-General or a Medical Officer of Health may au-thorise any person to administer a vaccine for the purposes ofan approved immunisation programme if that person, follow-ing written application, provides documentary evidence satis-fying the Director-General or the Medical Officer of Health,as the case may be, that that person—(a) can carry out basic emergency techniques including re-suscitation and the treatment of anaphylaxis; and has knowledge of the safe and effective handling of im-munisation products and equipment; and can demonstrate clinical interpersonal skills; and has knowledge of the relevant diseases and vaccines inorder to be able to explain the vaccination to the patient,or to the parent or guardian of the patient who is toconsent to the vaccination on behalf of the patient, toensure that the patient or the parent or guardian of thepatient can give informed consent to the vaccination.
Reprinted as at1 December 2011 Medicines Regulations 1984
Subject to subclause (4), any authorisation given by the Dir-ector-General or a Medical Officer of Health under subclause(2) shall be valid for a period of 2 years and shall be subject tosuch conditions as the Director-General or the Medical Officerof Health, as the case may be, thinks fit.
An authorisation given to any person under subclause (2) maybe withdrawn at any time before its expiry if the Director-Gen-eral or a Medical Officer of Health is satisfied that the author-ised person has failed to comply with any condition specifiedby the Director-General or the Medical Officer of Health undersubclause (3).
Regulation 44A: inserted, on 17 April 1992, by regulation 4 of the MedicinesRegulations 1984, Amendment No 5 (SR 1992/43).
Regulation 44A(2)(a): amended, on 11 October 2001, by regulation of theMedicines Amendment Regulations 2001 (SR 2001/232).
Duty to supply information
The Medical Officer of Health may require any authorised pre-scriber to supply information relating to the prescribing, ad-ministering, or supplying of any prescription medicines if theMedical Officer of Health has reason to suspect that prescrip-tion medicines may have been improperly prescribed, admin-istered, or supplied by the authorised prescriber.
Every requirement to supply information must be in writing,stating the reasons for the Medical Officer of Health's suspi-cion.
The information that must be supplied is information justify-ing the prescription, administering, or supply of the prescrip-tion medicines as follows:(a) the age of the patient: the diagnosis of the patient's condition: the prognosis of the patient's condition: details of any specialist referral: any alternative treatments considered or tried.
An authorised prescriber to whom any such notice is sent mustsupply the required information in writing to the Medical Of-ficer of Health within 30 days.
Regulation 44B: inserted, on 18 September 1997, by of theMedicines Amendment Regulations 1997 (SR 1997/165).
Medicines Regulations 1984
Regulation 44B(1): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44B(4): amended, on 1 October 2005, by of theMedicines Amendment Regulations 2005 (SR 2005/255).
Export of prescription medicines
Part 7A: inserted, on 3 November 2000, by of the MedicinesAmendment Regulations 2000 (SR 2000/220).
44C No export of prescription medicines for retail sale without
New Zealand prescription
No person may export a prescription medicine in the courseor for the purpose of retail sale, otherwise than under a pre-scription given by a practitioner, a registered midwife, or adesignated prescriber.
The meaning of retail sale in subclause (1) must be determined
by reference to of the Act.
Subclause (1) is intended to limit the sale and supply of pre-scription medicines pursuant of the Act.
Regulation 44C: inserted, on 3 November 2000, by of theMedicines Amendment Regulations 2000 (SR 2000/220).
Supply of restricted medicine and
Part 7B: inserted, on 18 September 2004, by of the MedicinesAmendment Regulations 2004 (SR 2004/300).
44D Supply of restricted medicine and pharmacy-only
A person may, in the course of any business carried on bythat person, supply a restricted medicine or pharmacy-onlymedicine if he or she—(a) is authorised to supply the medicine in accordance witha standing order; and supplies that medicine in accordance with that standingorder.
Reprinted as at1 December 2011 Medicines Regulations 1984
The circumstances in which a person may supply a restrictedmedicine or pharmacy-only medicine under subclause (1) arein addition to the circumstances in which a person may supplya restricted medicine or pharmacy-only medicine of the Medicines Act 1981.
Regulation 44D: inserted, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Application for licence to manufacture, hawk, sell, or
pack medicine
Every application for a licence to manufacture, hawk, sell, orpack medicine must—(a) be made in of Schedule 2: be accompanied by the appropriate fee: the premises the applicant intends to use for theactivity to which the application relates; or in the case of an application for a licence to hawkmedicines, the area in which the applicant intendsto operate: specify the medicines, or the descriptions or classes ofmedicines, that the applicant proposes to manufacture,hawk, sell, or pack: the applicant's qualifications; or if the applicant is a body corporate, the qualifi-cations of every person who will, if the applica-tion is successful, be a responsible person for thepurposes of the licence to which the applicationrelates: in the case of an application for a licence to sell anymedicine by retail or to hawk any medicine, be accom-panied by a certificate of character that states that theapplicant—(i) is well known to the person giving the certificate;and is of good character; and Medicines Regulations 1984
is considered by the person giving the certificateto be a fit and proper person to be licensed to sellor hawk medicine.
A licence to undertake an activity referred to in subclause (1)may only be granted in respect of 1 place of business.
Despite subclause (2), the licensing authority may grant a li-cence that allows for the manufacture of medicine, or a de-scription or class of medicines, at more than 1 place of busi-ness if—(a) the application to which the licence relates is made bya body corporate; and the licensing authority is satisfied that the body corpo-rate has taken steps to ensure appropriate supervision ofthe manufacture of the product at each of the places ofbusiness.
Every applicant for a licence under this regulation must pro-vide the licensing authority with the following things if re-quired by the licensing authority under of the Act:(a) further information: an opportunity to inspect the applicant's premises andequipment.
The licensing authority may, in order to determine if a personto whom of the Act applies has a sufficientknowledge of the obligations of a licensee and of the hazardsassociated with the medicines to which a licence to manufac-ture, hawk, sell, or pack medicine relates, require that personto undertake and pass any oral, written, or practical tests thatthe licensing authority considers reasonably necessary in theparticular case.
Regulation 45: substituted, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
45A Application for licence to operate pharmacy
(1)
Every application for a licence to operate a pharmacy must—(a) in the case of a company, in of Schedule2; and Reprinted as at1 December 2011 Medicines Regulations 1984
in the case of a person (including a body corpo-rate that is not a company), in of Sched-ule 2; and be accompanied by—(i) the appropriate fee prescribed in and a completed statutory declaration (as set out inthe relevant form).
A licence to operate a pharmacy may only be granted in respectof 1 place of business.
Every applicant for a licence under this regulation must pro-vide the licensing authority with the following things if re-quired by the licensing authority under of the Act:(a) further information: an opportunity to inspect the applicant's premises andequipment.
The licensing authority may, in order to determine if a personto whom of the Act applies has a sufficientknowledge of the obligations of a licensee and of the hazardsassociated with the medicines to which a licence to operatea pharmacy relates, require that person to undertake and passany oral, written, or practical tests that the licensing authorityconsiders reasonably necessary in the particular case.
Regulation 45A: inserted, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Regulation 45A(1)(b)(i): substituted, on 21 August 2006, of theMedicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Form and conditions of licence
The following licences must be in the following forms:(a) a licence to manufacture medicines must be of Schedule 2: a licence to hawk medicines must be of Sched-ule 2: a licence to sell medicines by wholesale must be in of Schedule 2: a licence to sell medicines by retail must be of Schedule 2: Medicines Regulations 1984
a licence to pack medicines must be of Sched-ule 2: a licence to operate a pharmacy must be ofSchedule 2.
On granting a licence under the Act, the licensing authoritymay impose such conditions as he thinks fit.
Regulation 46(1): substituted, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Licence to manufacture medicines
Every application for a licence to manufacture any medicineshall specify which of the following descriptions or classes themedicine comes within or belongs to:(a) antibiotics and preparations of antibiotics: vaccines and sera: sterile preparations: hormones and steroid preparations: preparations, other than vitamins, that have a dose of5 milligrams or less per unit dose: antineoplastic agents and immunosuppressant agents,other than steroid preparations: other medicines.
Where an application to manufacture medicines applies to 1or more medicines or descriptions or classes of medicines, thelicensing authority may grant a licence for all the medicines ordescriptions or classes of medicines to which the applicationrelates, or for such of the medicines or descriptions or classesof medicines to which the application relates as the licensingauthority is satisfied the applicant is qualified to manufactureand capable of manufacturing.
Licence to hawk certain medicines
Subject to subclause (2), and without affecting the generality, every licence to hawk any prescriptionmedicine, restricted medicine, or pharmacy-only medicineshall be granted subject to the following conditions:(a) the licence shall apply only to those medicines or de-scriptions or classes of medicine specified in the li-cence: Reprinted as at1 December 2011 Medicines Regulations 1984
the licensee shall keep the stocks of medicines in a placeapproved by the licensing authority: where the licensing authority imposes a limit on thequantity of medicines that may be carried by the li-censee when hawking, the licensee shall not carrymedicines in excess of that quantity: the licensee shall hawk medicines only to those personsor classes of persons specified in the licence.
No person shall be granted a licence to hawk any prescriptionmedicines, restricted medicines, or pharmacy-only medicinesby retail.
48A Licensing authority to be advised of change in particulars
relating to operating pharmacy
A company or person who is granted a licence to operate apharmacy must advise the licensing authority as soon as prac-ticable of any change in the details that relate to the applicationfor that licence (including, without limitation, changes in thedetails of any additional information required by the licensingauthority).
A company that is granted a licence to operate a pharmacyunder of the Act must immediately advisethe licensing authority if there is a change or are changes inthe ownership of the share capital of the company that meansthat more than 50% of the share capital is no longer owned bya pharmacist or pharmacists.
The requirement imposed by subclause (2) is in addition to therequirement imposed by subclause (1).
Regulation 48A: inserted, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Surrender of licence
Subclause (1A) applies if a licensee ceases to—(a) manufacture, hawk, sell, or pack any medicine; or operate a pharmacy.
(1A) If this subclause applies, the licensee must, within 7 days of ceasing to undertake the activity to which the licence relates,surrender that licence to the licensing authority.
Medicines Regulations 1984
The licensing authority, on receiving a licence pursuant to sub-clause (1A), shall retain the licence for the remainder of thecurrent licence period.
Nothing in this regulation shall prevent a licensee who has sur-rendered his licence pursuant to subclause (1A) from applyingto the licensing authority for restoration of the licence to thelicensee at any time during the current licence period.
In any such case, but subject to subclause (5), the licensingauthority, on being satisfied that the licensee complies with therequirements of the Act and these regulations relating to thegranting of licences, shall restore the licence to the licensee.
Notwithstanding anything in these regulations, it shall not benecessary for any licensee who surrenders his licence to pay afurther licence fee on application for restoration of that licence.
Regulation 49(1): substituted, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Regulation 49(1A): inserted, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Regulation 49(2): amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Regulation 49(3): amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Withdrawal of medicines, etc
Withdrawal of medicines, etc
The Director-General may issue to any importer, manufac-turer, or seller of any medicine, related product, or medicaldevice an order—(a) directing the withdrawal from sale of any medicine, re-lated product, or medical device in respect of whichthere is in force a notice given by the Minister underof the Act, or of any portionof the produced quantity of any such medicine, relatedproduct, or medical device, if the Director-General be-lieves on reasonable grounds that such withdrawal is ne-cessary to protect the public; or directing the withdrawal from sale of any medicine, re-lated product, or medical device, or any portion of the Reprinted as at1 December 2011 Medicines Regulations 1984
produced quantity of any medicine, related product, ormedical device, that does not conform to the specifi-cations claimed for that medicine, related product, ormedical device; or requiring the disposal of any medicine or related prod-uct, or any specific quantity of a medicine or relatedproduct, that has been directed to be withdrawn underparagraph (a) or paragraph (b); or requiring the disposal or destruction of any medical de-vice, or any specific quantity of any medical device, thathas been directed to be withdrawn under paragraph (a)or paragraph (b).
The importer, manufacturer, or seller shall, on receipt of anorder made under subclause (1), advise the Director-Generalof the manner and time in which he proposes to comply withthe order, and shall give written notice to the Director-Generalwhen the order has been complied with.
Notwithstanding anything in subclause (2), the Director-Gen-eral may issue directions to the recipient of an order madeunder subclause (1) as to the manner and time in which theorder is to be complied with.
Data sheets
Interpretation
In this Part, unless the context otherwise requires, data sheet,
in relation to a medicine, means a document containing infor-
mation relating to the safe and effective use of the medicine.
Regulation 51: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Approval of data sheets for new medicines
A person who applies under of the Act for
the consent of the Minister to the distribution of a prescrip-
tion medicine or restricted medicine (an applicant) must in-
clude with his or her application a proposed data sheet for the
medicine in such form as may be required by guidelines issued
from time to time by the Ministry of Health.
Medicines Regulations 1984
On receipt of the proposed data sheet, the Minister may—(a) approve the data sheet; or require the data sheet to be resubmitted for approvalafter such changes have been made to it as the Ministerconsiders appropriate.
Within 10 days after the Minister's consent to the distribu-tion of a prescription medicine or restricted medicine has beennotified in the Gazette, the applicant must send to the Dir-ector-General for publication an electronic copy of the ap-proved data sheet for that medicine.
Regulation 52: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Approval of data sheets for changed medicines
An importer or manufacturer who gives to the Director-Gen-eral a notice under of the Act describing a ma-terial change to a prescription medicine or restricted medicinemust include with the notice a proposed revised data sheet forthe medicine in such form as may be required by guidelinesissued from time to time by the Ministry of Health if a revi-sion of the data sheet is necessary or desirable because of thematerial change.
On receipt of the proposed revised data sheet, the Director-General may—(a) approve the revised data sheet; or require the revised data sheet to be resubmitted for ap-proval after such changes have been made to it as theDirector-General considers appropriate.
After the Director-General has approved a revised data sheet,the Director-General must give written notice of the approvalto the importer or manufacturer.
Within 10 days after receiving a notice of approval under sub-clause (3), the importer or manufacturer must send to the Dir-ector-General for publication an electronic copy of the ap-proved revised data sheet.
Regulation 53: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Reprinted as at1 December 2011 Medicines Regulations 1984
Particulars in data sheets
[Revoked]
Regulation 54: revoked, on 1 August 2011, of the MedicinesAmendment Regulations 2011 (SR 2011/245).
54A Sale of Medicines Registers
(1)
This regulation applies to the sale of a medicine if it is—(a) a restricted medicine sold by retail otherwise than undera prescription; or a prescription medicine, restricted medicine, or phar-macy-only medicine, sold by wholesale.
A person who makes sales to which subclause (1) appliesmust—(a) maintain a Sale of Medicines Register for recording andkeeping the information stated in subclause (4); and ensure that the information kept in it is arranged in sucha way that the information about each particular sale canbe conveniently inspected, or retrieved and inspected.
The register must be in 1 or more of the following forms:(a) a system for recording and keeping the informationelectronically: a book for recording and keeping the information inwriting: some other system for recording and keeping the infor-mation, approved by the Director-General (either gen-erally or in any particular case) for the purposes of thisregulation.
The information to be recorded and kept in relation to eachsale is—(a) the date of the sale: the buyer's name: the address of the buyer's place of business or residence: the name of the medicine sold: the quantity of the medicine sold: the name of the person making the sale.
Regulation 54A: inserted, on 30 November 2000, by of theMedicines Amendment Regulations 2000 (SR 2000/220).
Medicines Regulations 1984
Records of sales by retail or wholesale
Before giving to the buyer a medicine to whose applies, the person making the sale must recordin the Sale of Medicines Register maintained under regulation54A(2) the information stated in regulation 54A(4).
It is not necessary to comply with subclause (1) in relationto a sale by wholesale if the information stated in can be discovered from the seller's books and records.
Regulation 55: substituted, on 30 November 2000, by of theMedicines Amendment Regulations 2000 (SR 2000/220).
Record of hawker's sales
Every person who hawks any prescription medicine, restrictedmedicine, or pharmacy-only medicine shall keep and maintaina "Hawker's Medicines" book that records the medicines thathe hawks or has in his possession.
Each page of the Hawker's Medicines book shall—(a) be in the form set out relate to only 1 form and 1 strength of 1 medicine.
The particulars in the Hawker's Medicines book shall be leg-ibly and indelibly entered not later than the ordinary businessday next following the day on which the medicine concernedwas sold.
Every person to whom subclause (1) applies shall—(a) satisfy himself that the purchaser is entitled to themedicine; and before selling the medicine to the purchaser, obtainfrom the purchaser a printed request for the medicine,signed and dated by the purchaser, that contains thefollowing particulars:(i) the date of each transaction: the name of the purchaser: the address of the place of business or residenceof the purchaser: the name of the medicine sold: the quantity of the medicine sold.
Reprinted as at1 December 2011 Medicines Regulations 1984
Record of supplies pursuant to prescriptions
Every person who dispenses or supplies any prescriptionmedicine or restricted medicine pursuant to a prescriptionshall, not later than the ordinary business day next followingthe day on which the medicine was dispensed or supplied,record that dispensing or supply of the medicine in a "Pre-scriptions" register, or in such other form, or within suchother period of time, as the Director-General may from timeto time approve.
(a) the date of each transaction: the name of the patient or (as the case may require) theowner of the animal: the address of the patient or (as the case may require)the owner of the animal: the name of the medicine supplied: the quantity of the medicine supplied: the name of the prescriber: in the case of a prescription medicine, the unique iden-tifying number or code of the prescription.
Records to be kept
The person responsible for a record to which this Part appliesmust keep it for at least 3 years after it was made (or, if it iskept together with other records, for at least 3 years after themost recent of them was made).
The person must keep the record—(a) in a secure place at his or her place of business; or in some other place authorised by the licensing author-ity.
Regulation 58: substituted, on 30 November 2000, by of theMedicines Amendment Regulations 2000 (SR 2000/220).
Medicines Regulations 1984
58A Substances that are not medicines or related products for
purposes of Act
The following classes of substances are not medicines or re-lated products for the purposes of the Act:(a) dentifrice products, provided that—(i) the dentifrice product does not contain amedicine specified and the dentifrice product is not claimed to be for usein relation to any therapeutic purpose other thanone or both of the following:(A) preventing dental decay: improving oral hygiene: anti-dandruff hair products, provided that—(i) the hair product does not contain a medicine spe-cified in ; and the hair product is not claimed to be for use inrelation to any therapeutic purpose except con-trolling dandruff; and the hair product is claimed to be effective throughcleansing, moisturising, exfoliating, or dryingthe scalp and not through any other process: anti-acne skin care products, provided that—(i) the skin care product does not contain a medicinespecified in and the skin care product is not claimed to be foruse in relation to any therapeutic purpose exceptpreventing acne; and the skin care product is claimed to be effect-ive through cleansing, moisturising, exfoliating,or drying the skin and not through any otherprocess: barrier cream products, provided that—(i) the barrier cream product does not contain amedicine specified and the barrier cream product is not claimed to be foruse in relation to any therapeutic purpose exceptpreventing nappy rash; and Reprinted as at1 December 2011 Medicines Regulations 1984
the barrier cream product is claimed to be ef-fective through providing a barrier to the trans-mission of moisture and not through any otherprocess: anti-bacterial skin products, provided that—(i) the product does not contain a medicine specifiedin ; and the product is not claimed to be for use in relationto any therapeutic purpose except preventing thespread of bacteria (but not a named bacterium);and the product is not presented as being for use inconnection with—(A) any procedure associated with the risk oftransmission of disease from contact withblood or other bodily fluids; or either of the procedures specified in sub-clause (2); and the product is not recommended for use in con-nection with the provision of health services (asdefined of the Health and DisabilityCommissioner Act 1994).
The procedures referred to in subclause (1)(e)(iii)(B) are—(a) piercing the skin or mucous membrane for any purpose;and venipuncture, or the delivery of an injection.
Regulation 58A: inserted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
General sale medicines may be sold by vending machine
The Director-General may, by notice in the Gazette,—(a) approve the sale of a general sale medicine by means ofa vending machine: specify any conditions to which an approval under para-graph (a) is subject: withdraw an approval given under paragraph (a): vary or revoke any conditions specified under paragraph(b), or specify additional conditions, to which an ap-proval under paragraph (a) is subject.
Medicines Regulations 1984
A notice given under subclause (1) takes effect on the day afterthe date of notification.
Regulation 59: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Certificate of analyst
The certificate of an analyst given for the purposes of the Act shall be in the form set out
The licence fees set out are payable for thelicences to which they relate.
The amount to be deposited with the Medicines Review Com-mittee pursuant of the Act shall be $9,000.
The fee to accompany an application made ofthe Act for the Minister's consent under of the Actshall be $122,625 where any active ingredient of the medicinethat is the subject of the application is not generally availableas at the date of that application.
The fee to accompany any other application made of the Act for the Minister's consent under of the Act shall be $43,875.
The fee to accompany an application made ofthe Act (as applied of the Act) for the Minis-ter's consent under of the Act in relation to a relatedproduct shall be $5,500.
The fee to accompany an application made ofthe Act for the Minister's provisional consent shall be $8,437.
The fee to accompany a notice deposited with the Director-General under of the Act shall be $3,200.
The fee to accompany an application made ofthe Act for the approval of a clinical trial, and of the persons(in that section called investigators) who will conduct that trial,shall be $9,843.
For the purposes of the Act, the fee for a copyof a certificate of an analyst, or (as the case may be) a copyof a report made by an analyst in respect of a sample, shall be$60.
Reprinted as at1 December 2011 Medicines Regulations 1984
For the purposes of the Act, the fee for procur-ing a sample of any medicine and submitting it for analysisshall be $600.
For the purposes of subclause (3), not generally available
means not legally available other than pursuant to an exemp-
tion granted under any or all of , ,
, or of the Act.
Regulation 61: substituted, on 29 August 1991, by regulation 2 of the MedicinesRegulations 1984, Amendment No 4 (SR 1991/134).
Regulation 61(1): substituted, on 21 August 2006, of theMedicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(3): amended, on 21 August 2006, of theMedicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(4): amended, on 21 August 2006, of theMedicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(6): amended, on 21 August 2006, of theMedicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(7): amended, on 21 August 2006, of theMedicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(8): amended, on 21 August 2006, of theMedicines (Fees) Amendment Regulations 2006 (SR 2006/188).
61A Waiver and refund of fees
(1)
The Director-General may, in a particular case or class ofcases, waive or refund, in whole or in part, any fee otherwisepayable In exercising his or her powers under subclause (1), the Dir-ector-General shall have regard to—(a) the time reasonably required to consider any applicationmade or notice given under the Act: the degree of complexity involved in considering anysuch application or notice: the interests of public health in New Zealand.
Regulation 61A: inserted, on 29 August 1991, by regulation 2 of the MedicinesRegulations 1984, Amendment No 4 (SR 1991/134).
Fees inclusive of goods and services tax
The fees fixed by these regulations are inclusive of goods and
services tax under .
Regulation 61B: inserted, on 29 August 1991, by regulation 2 of the MedicinesRegulations 1984, Amendment No 4 (SR 1991/134).
Medicines Regulations 1984
Medical devices
No person shall sell any medical device that is claimed to
operate by inducing, concentrating, directing, or producing,
or counteracting, screening, or giving protection from, any
magnetic, galvanic, electric, electronic, radiation, or vibratory
forces or effects unless—
(a)
such properties are, before or at the time of sale, quan-titatively described to the purchaser in writing in termsthat can be measured by scientific physical means; and the medical device demonstrably has the propertiesclaimed and described.
Restriction on, and supervision of, compounding medicine
A dispensary technician must not undertake any process ofcompounding a medicine.
The following persons may compound a medicine, but only ifunder the direct personal supervision of a pharmacist:(a) pharmacy graduates: pharmacy technicians: despite subclause (1), dispensary technicians who haveserved an apprenticeship in pharmacy under the Phar-macy Act 1939.
Regulation 63: substituted, on 19 December 2002, of theMedicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Every person commits an offence against these regulationswho—(a) contravenes or fails to comply with any of the provi-sions of , ,33(2), 33(3), ,35(3), 35(7), 35(9), , 39A(1),, 42(3), 42(4), or fails to comply with any order made by the Director-General under ; or Reprinted as at1 December 2011 Medicines Regulations 1984
contravenes or fails to comply with any of the provi-sions , ,56(3), , and Every person who commits an offence against these regula-tions is liable on summary conviction to a fine not exceeding$500.
Regulation 64(1)(a): amended, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Regulation 64(1)(a): amended, on 11 October 2001, of theMedicines Amendment Regulations 2001 (SR 2001/232).
Regulation 64(1)(a): amended, on 18 September 1997, of theMedicines Amendment Regulations 1997 (SR 1997/165).
Regulation 64(1)(c): amended, on 1 August 2011, by of theMedicines Amendment Regulations 2011 (SR 2011/245).
Appeals to District Court
Any occupier of premises in respect of which any decision hasbeen made by a Medical Officer of Health,may appeal against that decision to a District Court within 14days after being notified in writing of the decision.
An appeal under this regulation shall be made by way of ori-ginating application in accordance with the , and shall be filed in the office of the court nearestto the place of business or employment of the appellant.
On hearing an appeal brought under this regulation, the courtmay confirm, reverse, or modify the decision made by theMedical Officer of Health, and the decision of the court onthe appeal shall be final.
Regulation 65(2): amended, on 1 November 2009, pursuant to of theDistrict Courts Rules 2009 (SR 2009/257).
65A Transitional provision arising from enactment of
Medicines Amendment Regulations 2011
Until 1 February 2012, it is sufficient compliance with the ad-vertising requirements to comply withregulations 8 and 11 as in force immediately before 1 August2011.
For medicines and related products manufactured or importedbefore 1 September 2012, it is sufficient compliance with thelabelling requirements , and Medicines Regulations 1984
to comply with regulations 13 to 16, 22, 23, and 37as in force immediately before 1 August 2011.
Regulation 65A: inserted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
The regulations specified are hereby revoked.
Amendment(s) incorporated in the Drug Tariff 1981(SR 1981/171).
Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 1
Prescription, restricted, and
Schedule 1: substituted, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Every reference to a medicine in this schedule applies whetherthe medicine is synthetic in origin or is from biological or mineralsources.
Unless specific reference is made otherwise, every reference appliesalso to medicines that are—• preparations and admixtures containing any proportion of anysubstance listed in this schedule: salts and esters of any substance listed in this schedule: preparations or extracts of biological materials listed in thisschedule: salts or oxides of elements listed in this schedule.
Unless specific reference is made otherwise, every reference to amedicine in this schedule applies,—• if the medicine is an injection or eye preparation, to any con-centration of that medicine; and if the medicine is not an injection or eye preparation, only ifthe concentration of the medicine is greater than 10 milligramsper litre or per kilogram.
Where any reference is modified by a statement of the strength of themedicine, the strength is calculated using the free acid, base, alcohol,or element unless specifically stated otherwise.
Prescription medicines Amending or replacing this Part may affect designated prescriberregulations under section 105(1)(q) of the Act.
1 Medicines Regulations 1984
Abrus precatorius; at all strengths Acetylcholine; except in medicines containing 1 milligram orless per litre or per kilogram Acetylcysteine; for injection or inhalation Aciclovir; except for external use for the treatment of herpeslabialis Acokanthera ouabaio Acokanthera schimperi Aconitum spp.; except when specified elsewhere in this sched-ule Adenosine; for injection Reprinted as at1 December 2011 Medicines Regulations 1984
Adrenal extract; except for dermal use in medicines containing0.02% or less of ketosteroids Adrenaline; in medicines containing more than 1% Adrenocortical hormones; except adrenal extract for dermaluse containing 0.02% or less of ketosteroids Albumin; except human albumin Alclometasone; except when specified elsewhere in thisschedule Alcohol; for injection in medicines containing more than 20% Aldosterone; except in medicines containing 10 microgramsor less per litre or per kilogram Allylisopropylacetylurea; at all strengths Medicines Regulations 1984
Alpha -proteinase inhibitor Amethocaine; for internal use; for external use in medicinescontaining more than 10%; for ophthalmic use except whenused in practice by an optometrist registered with the Op-tometrists and Dispensing Opticians Board Aminocaproic acid Aminophenazone; at all strengths Aminophylline; except for oral use in liquid form in medicinescontaining 2% or less Reprinted as at1 December 2011 Medicines Regulations 1984
Aminosalicylic acid Amorolfine; except for external use Amygdalin; at all strengths Amyl nitrite; except when sold to a person who holds a con-trolled substances licence (issued under section 95B of theHazardous Substances and New Organisms Act 1996) author-ising the person to possess cyanide Anabolic steroids Medicines Regulations 1984
Anchusa officinalis; at all strengths Ancrod and its immunoglobulin antidote Androgenic and anabolic steroidal agents Antazoline; except for ophthalmic use Antibiotic substances; except when specified elsewhere in thisschedule Antihistamines; except when specified elsewhere in thisschedule Antimony; except in medicines containing 1 milligram or lessper litre or per kilogram Antisera; for injection Apocynum spp.
Apomorphine; except in medicines containing 1 milligram orless per litre or per kilogram Aristolochia spp.; at all strengths Aristolochic acid; at all strengths Reprinted as at1 December 2011 Medicines Regulations 1984
Arsenic; except in medicines containing 1 milligram or lessper litre or per kilogram Aspirin; for injection; when combined with caffeine, paraceta-mol, or salicylamide Atropa belladonna; except when specified elsewhere in thisschedule; except in medicines containing 300 micrograms orless of total solanaceous alkaloids per litre or per kilogram Atropine; except when specified elsewhere in this schedule;except when used as an antidote in a device designed for self-injection; except in medicines containing 300 micrograms orless per litre or per kilogram Atropine methonitrate Aurothiomalate sodium Azatadine; except when specified elsewhere in this schedule Medicines Regulations 1984
Azelaic acid; except for dermal use Azelastine; except when specified elsewhere in this schedule Beclomethasone; except when specified elsewhere in thisschedule Benethamine penicillin Benzathine penicillin Reprinted as at1 December 2011 Medicines Regulations 1984
Benzocaine; except when specified elsewhere in this sched-ule; except in dermal preparations containing 2% or less oftotal anaesthetic substances; except in lozenges containing 30milligrams or less of total anaesthetic substances per dosageunit Benzoyl metronidazole Benzoyl peroxide; except for external use in medicines con-taining 10% or less Benzydamine; for internal use Beta carotene; in medicines containing more than 18 mil-ligrams per recommended daily dose Bifonazole; except for dermal use Bismuth; except for external use in medicines containing 3%or less Bithionol; at all strengths Medicines Regulations 1984
Boron including borax and boric acid; except for internal usein medicines containing 6 milligrams or less per recommendeddaily dose; except in dermal medicines for use other than pae-diatric use containing 0.35% or less; except when present asan excipient Brompheniramine; except when specified elsewhere in thisschedule Brugmansia spp.
Buclizine; except for oral use Budesonide; except when specified elsewhere in this schedule Bufexamac; except in suppositories or for dermal use inmedicines containing 5% or less Buniodyl sodium; at all strengths Reprinted as at1 December 2011 Medicines Regulations 1984
Butoconazole; except for vaginal use Butyl aminobenzoate; except for dermal use in medicines con-taining 2% or less Butylchloral hydrate Cacalia spp.; at all strengths Calcipotriol; except in medicines containing not more than 50micrograms per gram or per millilitre and when sold in a packof not more than 30 grams or 30 millilitres by a pharmacist toan adult with mild to moderate psoriasis previously diagnosedby a doctor Calcium carbimide Calcium polystyrene sulphonate Calotropis gigantea Calotropis procera Medicines Regulations 1984
Carbaryl; except for external use in medicines containing 2%or less Carbenoxolone; for internal use Reprinted as at1 December 2011 Medicines Regulations 1984
Cephaelis acuminata; except in medicines containing less than0.2% of emetine Cephaelis ipecacuanha; except in medicines containing lessthan 0.2% of emetine Certolizumab pegol Medicines Regulations 1984
Cetirizine; except for oral use Chenodeoxycholic acid Chloral hydrate; except for dermal use in medicines containing2% or less Chloramphenicol; except when sold in practice by an op-tometrist registered with the Optometrists and DispensingOpticians Board; except when specified elsewhere in thisschedule Chloroform; for anaesthesia; except when specified elsewherein this schedule Chlorpheniramine; except when specified elsewhere in thisschedule Reprinted as at1 December 2011 Medicines Regulations 1984
Choline salicylate; except in medicines containing 10% or lessand in pack sizes of 15 grams or less Chorionic gonadotrophin; except in pregnancy test kits Ciclopirox; except for external use Cimetidine; except when specified elsewhere in this schedule Cinchocaine; for injection; for ophthalmic use; for externaluse in medicines containing more than 0.5% Clemastine; except for oral use Medicines Regulations 1984
Clioquinol; at all strengths Clobetasone; except when specified elsewhere in this schedule Clotrimazole; except when specified elsewhere in this sched-ule Cocaine; except when specified elsewhere in this schedule Codeine; except when specified elsewhere in this schedule Reprinted as at1 December 2011 Medicines Regulations 1984
Colecalciferol; in medicines containing more than 25 micro-grams per recommended daily dose except in parenteral nutri-tion replacement preparations Collagen; in injections or implants for tissue augmentation orcosmetic use Conium maculatum; at all strengths Convallaria keiski Convallaria majales Corifollitropin alfa Coronilla spp.
Cortisone and other steroidal hormones of the adrenal cor-tex; except when specified elsewhere in this schedule; exceptadrenal extract for dermal use in medicines containing 0.02%or less of ketosteroids Cotarnine; at all strengths Crotalaria spp.; at all strengths Croton tiglium; except in medicines containing 1 milligram orless per litre or per kilogram Medicines Regulations 1984
Cyclizine; except for oral use Cyclopentolate; except when used in practice by an op-tometrist registered with the Optometrists and DispensingOpticians Board Cynoglossum spp.; at all strengths Cyproheptadine; except for oral use Reprinted as at1 December 2011 Medicines Regulations 1984
Datura spp.; except for oral use when specified elsewhere inthis schedule; except datura stramonium or datura tatula forsmoking or burning Deoxyribonuclease; except for external use Desloratadine; except for oral use Medicines Regulations 1984
Dexchlorpheniramine; except when specified elsewhere in thisschedule Dextromethorphan; except when specified elsewhere in thisschedule Di-iodohydroxy quinoline; except for vaginal use Dibrompropamidine; except for ophthalmic use Diclofenac; except when specified elsewhere in this schedule;except for external use Reprinted as at1 December 2011 Medicines Regulations 1984
Digitalis purpurea Digoxin-specific antibody fragment Dimenhydrinate; except when specified elsewhere in thisschedule Dimethindene; except for oral use Dimethyl sulphoxide Diphemanil; except for dermal use Diphenhydramine; except when specified elsewhere in thisschedule Medicines Regulations 1984
Diphenoxylate; except when specified elsewhere in this sched-ule Diphtheria toxoid Diphtheria vaccine Doxylamine; except when specified elsewhere in this schedule Reprinted as at1 December 2011 Medicines Regulations 1984
Duboisia leichhardtii; except when specified elsewhere in thisschedule Duboisia myoporides; except when specified elsewhere in thisschedule Dulcin; at all strengths Econazole; except when specified elsewhere in this schedule Edetic acid; in medicines containing more than 0.25%; exceptin contact lens preparations; except dicobalt edetate for thetreatment of cyanide poisoning Eltrombopag olamine Emetine; in medicines containing more than 0.2% Medicines Regulations 1984
Ergocalciferol; in medicines containing more than 25 micro-grams per recommended daily dose Erysimum spp.; except in medicines containing 1 milligram orless per litre or per kilogram Reprinted as at1 December 2011 Medicines Regulations 1984
Ethanolamine; for injection Ether; for anaesthesia Ethyl chloride; for inhalation Ethyl loflazepate Ethylhexanediol; at all strengths Etidronic acid; except in medicines for external use containing1% or less Etofenamate; except for external use Medicines Regulations 1984
Factor VIII inhibitor bypassing fraction Famciclovir; except when specified elsewhere in this schedule Famotidine; except when specified elsewhere in this schedule Farfugium japonicum; at all strengths Felbinac; except for external use Felypressin; except when combined with a local anaestheticand used in practice by a dental therapist registered with theDental Council Fexofenadine; except for oral use Fibrinolysin; except for external use Reprinted as at1 December 2011 Medicines Regulations 1984
Fluconazole; except when specified elsewhere in this schedule Fluorescein; for injection Fluorides; for internal use in medicines containing more than0.5 milligrams per dose unit except in medicines containing15 milligrams or less per litre or per kilogram; except in par-enteral nutrition replacement preparations; for external use inmedicines containing more than 5.5 grams per litre or per kilo-gram except when supplied to a dental professional registeredwith the Dental Council Medicines Regulations 1984
Flurbiprofen; except in locally acting oromucosal preparationscontaining 10 milligrams or less per dosage unit Fluticasone; except when specified elsewhere in this schedule Folic acid; for injection except in parenteral nutrition replace-ment preparations Folinic acid; for injection Follicle-stimulating hormone; except in medicines containing100 micrograms or less per litre or per kilogram Reprinted as at1 December 2011 Medicines Regulations 1984
Galanthus spp.
Gemtuzumab ozogamicin Glatiramer acetate Glutathione; for injection Glyceryl trinitrate; for injection; for transdermal use; except inmedicines containing 100 micrograms or less per litre or perkilogram Glycopyrronium; for injection Medicines Regulations 1984
Gonadotrophic hormones; except when specified elsewhere inthis schedule Guaiphenesin; for oral use in medicines containing more than2% or 200 milligrams per dose form except when specifiedelsewhere in this schedule; except for oral use in modified re-lease form with a maximum recommended daily dose of notmore than 2.4 grams sold in a pack containing not more than5 days' supply approved by the Minister or the Director-Gen-eral for distribution as a general sale medicine Haemophilus influenzae vaccine; except in oral vaccines forthe prophylaxis of bacterial complications of colds Haloperidol; except in medicines containing 1 milligram orless per litre or per kilogram Halquinol; for internal use Heliotropium spp.; at all strengths Heparins; for internal use; except when present as an excipient Reprinted as at1 December 2011 Medicines Regulations 1984
Hepatitis A vaccine Hepatitis B vaccine Hexachlorophane; in medicines containing more than 3% Hexetidine; for internal use Histamine; in medicines containing more than 0.5% Human chorionic gonadotrophin; except in pregnancy test kits Human papillomavirus vaccine Hyaluronic acid; in injections or implants for tissue augmen-tation or cosmetic use Hydrocortisone; except when specified elsewhere in thisschedule Hydrocyanic acid; except when specified elsewhere in thisschedule; except in medicines containing 1 microgram or lessper litre or per kilogram Hydroquinone; except in medicines for external use contain-ing 2% or less Medicines Regulations 1984
Hylan polymer; in injections or implants for tissue augmenta-tion or cosmetic use Hyoscine; except when specified elsewhere in this schedule;except in medicines containing 300 micrograms or less perlitre or per kilogram Hyoscine butylbromide; except when specified elsewhere inthis schedule Hyoscyamine; except when specified elsewhere in this sched-ule; except in medicines containing 300 micrograms or lessper litre or per kilogram Hyoscyamus niger; except when specified elsewhere in thisschedule; except in medicines containing 300 micrograms orless of total solanaceous alkaloids per litre or per kilogram Hypothalamic releasing factors Hypromellose; for injection; except in intraocular viscoelasticproducts Ibritumomab tiuxetan Ibuprofen; except when specified elsewhere in this schedule Idoxuridine; except for dermal use in medicines containing0.5% or less Reprinted as at1 December 2011 Medicines Regulations 1984
Indomethacin; except for external use in medicines containing1% or less; except in medicines containing 1 milligram or lessper litre or per kilogram Influenza and coryza vaccines; for injection; for nasal use Ipecacuanha; except in medicines containing less than 0.2%of emetine Ipratropium; except for nasal use Iron; for injection except in parenteral nutrition replacementpreparations Isoconazole; except when specified elsewhere in this schedule Medicines Regulations 1984
Isopropamide; except for dermal use in preparations contain-ing 2% or less Isosorbide dinitrate Isosorbide mononitrate Japanese encephalitis vaccine Juniperus sabina; at all strengths Ketoconazole; except for dermal use Ketoprofen; except when specified elsewhere in this schedule;except for dermal use Ketotifen; except for ophthalmic use in medicines containing0.025% or less Reprinted as at1 December 2011 Medicines Regulations 1984
Lansoprazole; except when specified elsewhere in this sched-ule Lauromacrogols; for injection Leucovorin; for injection 1000 Levobupivacaine1001 Levocabastine; except for nasal or ophthalmic use1002 Levocetirizine; except for oral use1003 Levodopa1004 Levomepromazine Medicines Regulations 1984
1005 Levonorgestrel; except when specified elsewhere in this schedule; except in medicines for use as emergency post-coitalcontraception when sold by nurses recognised by their pro-fessional body as having competency in the field of sexualand reproductive health 1006 Levosimendan1007 Lidoflazine1008 Lignocaine; for injection except when used as a local anaes- thetic in practice by a nurse whose scope of practice permitsthe performance of general nursing functions or by a podi-atrist registered with the Podiatry Board or dental therapistregistered with the Dental Council; for oral use except inthroat lozenges containing 30 milligrams or less per doseform; for ophthalmic use except when used in practice by anoptometrist registered with the Optometrists and DispensingOpticians Board; for external use in medicines containingmore than 10% 1009 Ligularia dentata; at all strengths1010 Lincomycin1011 Lindane; except for external use in medicines containing 2% 1012 Linezolid1013 Liothyronine1014 Liraglutide1015 Lisinopril1016 Lisuride1017 Lithium; except when specified elsewhere in this schedule; ex- cept when present as an excipient in dermal medicines contain-ing 0.25% or less 1018 Lodoxamide; except in medicines for ophthalmic use1019 Lofexidine1020 Lomefloxacin1021 Lomustine1022 Loperamide; except when specified elsewhere in this schedule1023 Lopinavir Reprinted as at1 December 2011 Medicines Regulations 1984
1024 Loprazolam1025 Loracarbef1026 Loratadine; except for oral use1027 Lorazepam1028 Lormetazepam1029 Losartan1030 Loxapine1031 Lumefantrine1032 Lumiracoxib1033 Luteinising hormone1034 Lymecycline1035 Mafenide1036 Mannomustine1037 Maprotiline1038 Maraviroc1039 Mazindol1040 Measles vaccine1041 Mebanazine1042 Mebeverine1043 Mebhydrolin1044 Mebolazine1045 Mebutamate1046 Mecamylamine1047 Mecasermin1048 Mecillinam1049 Meclocycline1050 Meclofenamate1051 Meclofenoxate1052 Meclozine; except when specified elsewhere in this schedule1053 Medazepam1054 Medigoxin1055 Medroxyprogesterone1056 Medrysone Medicines Regulations 1984
1057 Mefenamic acid; except when specified elsewhere in this 1058 Mefloquine1059 Mefruside1060 Megestrol1061 Melagatran1062 Melatonin1063 Melengestrol1064 Melia azedarach; at all strengths1065 Meloxicam1066 Melphalan1067 Memantine1068 Meningococcal vaccine1069 Menotrophin1070 Mepacrine1071 Mepenzolate1072 Mephenesin1073 Mephentermine1074 Mepindolol1075 Mepitiostane1076 Mepivacaine1077 Meprobamate1078 Meptazinol1079 Mepyramine; except when specified elsewhere in this sched- 1080 Mequitazine1081 Mercaptomerin1082 Mercaptopurine1083 Mercury; except when specified elsewhere in this schedule; except in medicines containing 1 milligram or less per litre orper kilogram 1084 Meropenem1085 Mersalyl Reprinted as at1 December 2011 Medicines Regulations 1984
1086 Mesabolone1087 Mesalazine1088 Mesna1089 Mestanolone1090 Mesterolone1091 Mestranol1092 Metamfetamine1093 Metandienone1094 Metaraminol1095 Metenolone1096 Metergoline1097 Metformin1098 Methacholine1099 Methacycline1100 Methadone1101 Methallenoestril1102 Methandriol1103 Methanthelinium1104 Methazolamide1105 Methdilazine; except for oral use1106 Methicillin1107 Methimazole1108 Methisazone1109 Methixene1110 Methocarbamol1111 Methohexitone1112 Methoin1113 Methotrexate1114 Methoxamine; except for external use1115 Methoxsalen1116 Methoxyflurane1117 Methsuximide1118 Methyclothiazide Medicines Regulations 1984
1119 Methyl aminolevulinate1120 Methyl androstanolone1121 Methyl clostebol1122 Methyl mercury; except in medicines containing 300 micro- grams or less per litre or per kilogram 1123 Methyl salicylate; for internal use except when present as an excipient in medicines containing 1.04% or less per dose form 1124 Methyl trienolone1125 Methyldopa1126 Methylene blue; for injection1127 Methylergometrine1128 Methylnaltrexone1129 Methylpentynol1130 Methylphenidate1131 Methylphenobarbital1132 Methylprednisolone1133 Methyltestosterone1134 Methylthiouracil1135 Methyprylon1136 Methysergide1137 Metoclopramide; except when specified elsewhere in this 1138 Metolazone1139 Metoprolol1140 Metribolone1141 Metrifonate1142 Metronidazole1143 Metyrapone1144 Mexiletine1145 Mezlocillin1146 Mianserin1147 Mibefradil1148 Mibolerone Reprinted as at1 December 2011 Medicines Regulations 1984
1149 Miconazole; except when specified elsewhere in this schedule1150 Midazolam1151 Midodrine1152 Mifepristone1153 Miglitol1154 Miglustat1155 Milrinone1156 Minocycline1157 Minoxidil; except for dermal use in medicines containing 5% 1158 Mirtazapine1159 Misoprostol1160 Mitobronitol1161 Mitomycin1162 Mitoxantrone1163 Mitragyna speciosa1164 Mitragynine1165 Mivacurium1166 Moclobemide1167 Modafinil1168 Molgramostim1169 Molindone1170 Mometasone; except when specified elsewhere in this sched- 1171 Monobenzone1172 Monoclonal antibodies; except in pregnancy test kits1173 Montelukast1174 Moperone1175 Morazone1176 Moricizine1177 Morphine; except when specified elsewhere in this schedule1178 Motrazepam1179 Motretinide Medicines Regulations 1984
1180 Moxifloxacin1181 Mumps vaccine1182 Mupirocin1183 Muraglitazar1184 Muromonab1185 Mustine1186 Mycophenolic acid1187 Nabilone1188 Nabumetone1189 Nadolol1190 Nadroparin1191 Nafarelin1192 Naftidrofuryl1193 Nalbuphine1194 Nalidixic acid1195 Nalorphine1196 Naloxone1197 Naltrexone1198 Nandrolone1199 Naproxen; except when specified elsewhere in this schedule1200 Naratriptan1201 Natalizumab1202 Natamycin1203 Nateglinide1204 Nebacumab1205 Nebivolol1206 Nedocromil1207 Nefazodone1208 Nefopam1209 Nelfinavir1210 Neomycin1211 Neostigmine1212 Nepafenac Reprinted as at1 December 2011 Medicines Regulations 1984
1213 Nerium oleander1214 Nesiritide1215 Netilmicin1216 Nevirapine1217 Nialamide1218 Nicardipine1219 Nicergoline1220 Nicofuranose1221 Nicorandil1222 Nicotine; for nasal use except when sold from a smoking ces- sation clinic run under the auspices of a registered medicalpractitioner; in medicines other than for smoking cessation 1223 Nicotinic acid except nicotinamide; in medicines containing more than 250 milligrams per dose form 1224 Nicoumalone1225 Nifedipine1226 Nifenazone1227 Nikethamide1228 Nilotinib1229 Nilutamide1230 Nimesulide1231 Nimetazepam1232 Nimodipine1233 Nimorazole1234 Niridazole1235 Nisoldipine1236 Nitrazepam1237 Nitrendipine1238 Nitric oxide1239 Nitrofurantoin1240 Nitrofurazone1241 Nitrous oxide1242 Nitroxoline Medicines Regulations 1984
1243 Nizatidine; except when specified elsewhere in this schedule1244 Nomifensine1245 Noradrenaline1246 Norandrostenolone1247 Norbolethone1248 Norclostebol1249 Nordazepam1250 Norelgestromin1251 Norethandrolone1252 Norethisterone1253 Norfloxacin1254 Norgestrel1255 Noribogaine1256 Normethandrone1257 Nortriptyline1258 Noxiptyline1259 Nux vomica; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine 1260 Nystatin; except when specified elsewhere in this schedule1261 Octamylamine1262 Octatropine1263 Octreotide1264 Octyl nitrite1265 Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram 1266 Oestriol1267 Oestrogens1268 Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram 1269 Ofloxacin1270 Olanzapine1271 Oleandomycin1272 Oleandrin Reprinted as at1 December 2011 Medicines Regulations 1984
1273 Olmesartan1274 Olopatadine1275 Olsalazine1276 Omalizumab1277 Omeprazole; except when specified elsewhere in this schedule1278 Ondansetron1279 Opipramol1280 Opium; except when specified elsewhere in this schedule1281 Orciprenaline1282 Orlistat; except in medicines for weight control containing 120 milligrams or less per dose form 1283 Ornidazole1284 Ornipressin1285 Orphenadrine1286 Orthopterin1287 Oseltamivir; except when sold in a pharmacy between the months of April to November inclusive by a registeredpharmacist who is satisfied that the medicine is for the treat-ment of a consumer who is resident in New Zealand, is 12years of age or more, and currently has the symptoms ofinfluenza 1288 Ouabain1289 Ovandrotone1290 Oxabolone1291 Oxacillin1292 Oxaliplatin1293 Oxandrolone1294 Oxaprozin1295 Oxazepam1296 Oxazolam1297 Oxcarbazepine1298 Oxedrine; in medicines containing more than 30 milligrams per recommended daily dose Medicines Regulations 1984
1299 Oxetacaine; except for internal use1300 Oxiconazole; except when specified elsewhere in this schedule1301 Oxitropium1302 Oxolamine1303 Oxolinic acid1304 Oxpentifylline1305 Oxprenolol1306 Oxybuprocaine; except when used in practice by an op- tometrist registered with the Optometrists and DispensingOpticians Board 1307 Oxybutynin1308 Oxycodone1309 Oxymesterone1310 Oxymetholone1311 Oxyphenbutazone1312 Oxyphencyclimine1313 Oxyphenisatin; at all strengths1314 Oxyphenonium1315 Oxytetracycline1316 Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram 1317 Paclitaxel1318 Palifermin1319 Paliperidone1320 Palivizumab1321 Palonosetron1322 Pamaquin1323 Pamidronic acid1324 Pancreatic enzymes; in medicines containing more than 20 000 BP units of lipase activity 1325 Pancuronium1326 Panitumumab Reprinted as at1 December 2011 Medicines Regulations 1984
1327 Pantoprazole; except when specified elsewhere in this sched- 1328 Papaveretum1329 Papaverine; for injection1330 Paracetamol; except when specified elsewhere in this schedule1331 Paraldehyde1332 Paramethadione1333 Paramethasone1334 Parecoxib1335 Paricalcitol1336 Paromomycin1337 Paroxetine1338 Pazopanib1339 Pecazine1340 Pefloxacin1341 Pegaptanib1342 Pegfilgrastim1343 Peginterferon1344 Pegvisomant1345 Pemetrexed1346 Pemoline1347 Pempidine1348 Penbutolol1349 Penciclovir; except for external use for the treatment of herpes 1350 Penicillamine1351 Pentaerythrityl tetranitrate1352 Pentagastrin1353 Pentamethonium1354 Pentamidine1355 Pentazocine1356 Penthienate1357 Pentolinium Medicines Regulations 1984
1358 Pentosan polysulfate sodium1359 Pentoxifylline1360 Pergolide1361 Perhexiline1362 Pericyazine1363 Perindopril1364 Permethrin; in medicines containing more than 5%1365 Perphenazine1366 Pertussis antigen1367 Pertussis (whooping cough) vaccine1368 Pethidine1369 Phenacemide1370 Phenacetin; except when present as an excipient1371 Phenaglycodol1372 Phenazone; except for external use1373 Phenazopyridine1374 Phenelzine1375 Pheneticillin1376 Phenformin1377 Phenglutarimide1378 Phenindione1379 Pheniramine; except when specified elsewhere in this schedule1380 Phenisatin1381 Phenobarbital1382 Phenol; for injection1383 Phenolphthalein1384 Phenoperidine1385 Phenoxybenzamine1386 Phenoxymethylpenicillin1387 Phensuximide1388 Phentermine1389 Phenthimentonium1390 Phentolamine Reprinted as at1 December 2011 Medicines Regulations 1984
1391 Phenylbutazone1392 Phenylephrine; except when specified elsewhere in this sched- 1393 Phenylpropanolamine1394 Phenyltoloxamine1395 Phenytoin1396 Pholcodine; except when specified elsewhere in this schedule1397 Phosphodiesterase type 5 inhibitors; except when present as an unmodified, naturally occurring substance; except when spe-cified elsewhere in this schedule 1398 Phthalylsulfathiazole1399 Physostigmine1400 Picric acid1401 Picrotoxin1402 Pilocarpine; except in medicines containing 0.025% or less1403 Pimecrolimus1404 Pimozide1405 Pinacidil1406 Pinazepam1407 Pindolol1408 Pioglitazone1409 Pipecuronium1410 Pipemidic acid1411 Pipenzolate1412 Piperacillin1413 Piperidine1414 Piperidolate1415 Pipobroman1416 Pipothiazine1417 Pipradrol1418 Piracetam1419 Pirbuterol1420 Pirenoxine Medicines Regulations 1984
1421 Pirenzepine1422 Piretanide1423 Piroxicam; except for external use1424 Pirprofen1425 Pituitary hormones1426 Pivampicillin1427 Pizotifen1428 Plicamycin1429 Pneumococcal vaccine; except in oral vaccines for the prophy- laxis of bacterial complications of colds 1430 Podophyllotoxin; for internal use; for external use for the treatment of anogenital warts; for other external use inmedicines containing more than 1%; except in medicinescontaining 1 milligram or less of podophyllin per litre or perkilogram 1431 Podophyllum emodi; for internal use; for external use for the treatment of anogenital warts; for other external use inmedicines containing more than 20% of podophyllin; exceptin medicines containing 1 milligram or less of podophyllinper litre or per kilogram 1432 Podophyllum peltatum; for internal use; for external use for the treatment of anogenital warts; for other external use inmedicines containing more than 20% of podophyllin; exceptin medicines containing 1 milligram or less of podophyllin perlitre or per kilogram 1433 Polidexide1434 Poliomyelitis vaccine1435 Polyacrylamide; in injections or implants for tissue augmen- tation or cosmetic use 1436 Polyestradiol1437 Polylactic acid; in injections or implants for tissue augmenta- tion or cosmetic use 1438 Polymyxin1439 Polysulfated glycosaminoglycans; for injection except in in- traocular viscoelastic products Reprinted as at1 December 2011 Medicines Regulations 1984
1440 Polythiazide1441 Poractant alfa1442 Posaconazole1443 Potassium bromide1444 Potassium perchlorate1445 Practolol1446 Pralidoxime1447 Pramipexole1448 Pramocaine1449 Prampine1450 Prasterone1451 Prasugrel1452 Pravastatin1453 Prazepam1454 Praziquantel1455 Prazosin1456 Prednisolone1457 Prednisone1458 Pregabalin1459 Pregnenolone1460 Prenalterol1461 Prenylamine1462 Prilocaine; for injection except when used as a local anaes- thetic in practice by a dental therapist registered with the Den-tal Council; except when specified elsewhere in this schedule 1463 Primaquine1464 Primidone1465 Probenecid1466 Probucol1467 Procainamide1468 Procaine1469 Procaine penicillin1470 Procarbazine Medicines Regulations 1984
1471 Prochlorperazine; except when specified elsewhere in this schedule; except when sold for the treatment of nausea asso-ciated with emergency contraception by pharmacists or nursesaccredited to sell levonorgestrel for emergency contraception 1472 Procyclidine; except for dermal use in medicines containing 1473 Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram 1474 Progestogens1475 Proglumide1476 Proguanil1477 Prolintane1478 Promazine1479 Promethazine; except when specified elsewhere in this sched- 1480 Promoxolane1481 Propafenone1482 Propamidine; except for ophthalmic use1483 Propanidid1484 Propantheline1485 Propetandrol1486 Propionibacterium acnes1487 Propofol1488 Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram 1489 Propylthiouracil1490 Propyphenazone1491 Proquazone1492 Proscillaridin1493 Prostaglandins1494 Protamine1495 Prothionamide1496 Prothipendyl Reprinted as at1 December 2011 Medicines Regulations 1984
1497 Protirelin1498 Protoveratrines1499 Protriptyline1500 Proxymetacaine; except when used in practice by an op- tometrist registered with the Optometrists and DispensingOpticians Board 1501 Pseudoephedrine; except when specified elsewhere in this 1502 Pulmonaria spp.; at all strengths1503 Pyrazinamide1504 Pyridinolcarbamate1505 Pyridostigmine1506 Pyridoxal; in medicines containing more than 200 milligrams per recommended daily dose 1507 Pyridoxamine; in medicines containing more than 200 mil- ligrams per recommended daily dose 1508 Pyridoxine; in medicines containing more than 200 milligrams per recommended daily dose 1509 Pyrimethamine1510 Pyrvinium1511 Quazepam1512 Quetiapine1513 Quinagolide1514 Quinapril1515 Quinbolone1516 Quinethazone1517 Quinidine1518 Quinine; except in medicines containing 50 milligrams or less per recommended daily dose 1519 Quinisocaine1520 Quinupristin1521 Rabeprazole1522 Rabies vaccine Medicines Regulations 1984
1523 Raloxifene1524 Raltegravir1525 Raltitrexed1526 Ramipril1527 Ranibizumab1528 Ranitidine; except when specified elsewhere in this schedule; except in medicines containing 150 milligrams or less per doseunit that have received the consent of the Minister or the Dir-ector-General to their distribution as general sale medicinesand that are sold in the manufacturer's original pack contain-ing not more than 7 days' supply 1529 Rapacuronium1530 Rasagiline1531 Rasburicase1532 Rauwolfia serpentina1533 Rauwolfia vomitoria1534 Razoxane1535 Reboxetine1536 Remifentanil1537 Remoxipride1538 Repaglinide1539 Reserpine1540 Reteplase1541 Ribavirin1542 Rifabutin1543 Rifampicin1544 Rifamycin1545 Rifapentine1546 Riluzole1547 Rimexolone1548 Rimiterol1549 Rimonabant1550 Risedronic acid Reprinted as at1 December 2011 Medicines Regulations 1984
1551 Risperidone1552 Ritodrine1553 Ritonavir1554 Rituximab1555 Rivaroxaban1556 Rivastigmine1557 Rizatriptan; except when specified elsewhere in this schedule1558 Rocuronium1559 Rofecoxib1560 Roflumilast1561 Rolitetracycline1562 Romiplostim1563 Ropinirole1564 Ropivacaine1565 Rosiglitazone1566 Rosoxacin1567 Rosuvastatin1568 Rotavirus vaccine1569 Rotigotine1570 Roxibolone1571 Roxithromycin1572 Rubella vaccine1573 Ruboxistaurin1574 Sabadilla; except in preparations containing 10 milligrams or less of total alkaloids of Schoenocaulon officinale per litre orper kilogram 1575 Safrole; for internal use except in medicines containing 0.1% 1576 Salbutamol1577 Salcatonin1578 Salmeterol1579 Saquinavir1580 Saxagliptin Medicines Regulations 1984
1581 Schoenocaulon officinale; except in preparations containing 10 milligrams or less of total alkaloids of Schoenocaulon of-ficinale per litre or per kilogram 1582 Scopolia carniolica1583 Secbutabarbital1584 Secobarbital1585 Selegiline1586 Selenium; except when specified elsewhere in this schedule; except for oral use in medicines containing 150 microgramsor less per recommended daily dose; except for external use inmedicines containing 3.5% or less of selenium sulphide 1587 Sermorelin1588 Sertindole1589 Sertraline1590 Serum, dried human1591 Sevelamer1592 Sevoflurane1593 Sex hormones and all substances having sex hormone activity1594 Sialoepoetin1595 Sibutramine1596 Silandrone1597 Sildenafil and its structural analogues1598 Silicones; for injection1599 Silver sulfadiazine; except for external use in packs containing 1600 Simvastatin1601 Sirolimus1602 Sisomicin1603 Sitagliptin1604 Sitaxentan1605 Sodium bromide1606 Sodium cellulose phosphate; for internal use1607 Sodium cromoglycate; except for nasal and ophthalmic use Reprinted as at1 December 2011 Medicines Regulations 1984
1608 Sodium morrhuate; for injection1609 Sodium nitroprusside1610 Sodium phosphate; in oral laxative preparations1611 Sodium polystyrene sulphonate1612 Sodium tetradecyl sulphate; for injection1613 Solasadine1614 Solifenacin1615 Somatostatin1616 Somatropin1617 Sontoquine1618 Sorafenib1619 Sotalol1620 Sparfloxacin1621 Sparteine1622 Spectinomycin1623 Spiramycin1624 Spirapril1625 Spironolactone1626 Stanolone1627 Stanozolol1628 Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds 1629 Stavudine1630 Stenbolone1631 Steroid hormones1632 Stilboestrol1633 Stramonium; except for oral use where specified elsewhere in this schedule; except Datura stramonium or Datura tatula forsmoking or burning 1634 Streptococcus beta-haemolyticus vaccine; except in oral vac- cines for the prophylaxis of bacterial complications of colds 1635 Streptodornase1636 Streptokinase Medicines Regulations 1984
1637 Streptomycin1638 Strontium ranelate1639 Strophanthins1640 Strophanthus spp.
1641 Strychnos spp.; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine 1642 Styramate1643 Succimer1644 Sufentanil1645 Sugammadex1646 Sulbactam1647 Sulconazole; except for dermal use1648 Sulfacetamide; except for ophthalmic use in medicines con- taining 10% or less 1649 Sulfadiazine; except silver sulfadiazine for external use in pack sizes of 50 grams or less 1650 Sulfadimethoxine1651 Sulfadimidine1652 Sulfadoxine1653 Sulfafurazole1654 Sulfaguanidine1655 Sulfamerazine1656 Sulfamethizole1657 Sulfamethoxazole1658 Sulfamethoxydiazine1659 Sulfamethoxypyridazine1660 Sulfametrole1661 Sulfamonomethoxine1662 Sulfamoxole1663 Sulfaphenazole1664 Sulfapyridine1665 Sulfasalazine1666 Sulfathiazole Reprinted as at1 December 2011 Medicines Regulations 1984
1667 Sulfatroxazole1668 Sulfinpyrazone1669 Sulfomyxin1670 Sulfonmethane1671 Sulindac1672 Sultamicillin1673 Sulthiame1674 Sumatriptan; except when specified elsewhere in this schedule1675 Sunitinib1676 Suprofen1677 Sutilains1678 Suxamethonium1679 Suxethonium1680 T cell receptor antibody1681 Tacrine1682 Tacrolimus1683 Tadalafil and its structural analogues1684 Tamoxifen1685 Tamsulosin1686 Tanacetum vulgare; in medicines containing more than 0.8% 1687 Tapentadol1688 Tasonermin1689 Tazarotene1690 Tazobactam1691 Tegafur1692 Tegaserod1693 Teicoplanin1694 Telbivudine1695 Telithromycin1696 Telmisartan1697 Temazepam1698 Temozolomide Medicines Regulations 1984
1699 Temsirolimus1700 Tenecteplase1701 Teniposide1702 Tenofovir1703 Tenoxicam1704 Terazosin1705 Terbinafine; except when specified elsewhere in this schedule1706 Terbutaline1707 Terfenadine1708 Teriparatide1709 Terlipressin1710 Terodiline1711 Teropterin1712 Testolactone1713 Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram 1714 Tetanus antitoxin1715 Tetanus toxoid1716 Tetanus vaccine1717 Tetrabenazine1718 Tetracosactrin1719 Tetracycline1720 Tetraethylammonium1721 Tetrahydrocannabinol1722 Tetrazepam1723 Tetroxoprim1724 Thalidomide1725 Thenyldiamine1726 Theophylline; except in liquid form for oral use in medicines containing 2% or less 1727 Thevetia peruviana1728 Thevetin1729 Thiambutosine Reprinted as at1 December 2011 Medicines Regulations 1984
1730 Thiazosulfone1731 Thiethylperazine1732 Thioacetazone1733 Thiocarlide1734 Thioguanine1735 Thiomesterone1736 Thiopentone1737 Thiopropazate1738 Thioproperazine1739 Thioridazine1740 Thiotepa1741 Thiothixene1742 Thiouracil1743 Thiourea; except in medicines containing 0.1% or less1744 Thymoxamine1745 Thyroid1746 Thyrotrophin1747 Thyrotrophin-releasing factor1748 Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram 1749 Tiagabine1750 Tiaprofenic acid1751 Tiaramide1752 Tibolone1753 Ticarcillin1754 Ticlopidine1755 Tiemonium1756 Tienilic acid1757 Tigecycline1758 Tigloidine1759 Tiletamine1760 Tilidine1761 Tiludronic acid Medicines Regulations 1984
1762 Timolol1763 Tinidazole1764 Tinzaparin1765 Tioconazole; except when specified elsewhere in this schedule1766 Tiotropium1767 Tipepidine1768 Tiprinavir1769 Tirilazad1770 Tirofiban1771 Tobramycin1772 Tocainide1773 Tocilizumab1774 Tolazamide1775 Tolazoline1776 Tolbutamide1777 Tolcapone1778 Tolfenamic acid1779 Tolmetin1780 Tolonium1781 Tolpropamine1782 Tolrestat1783 Tolterodine1784 Topiramate1785 Topotecan1786 Torasemide1787 Toremifene1788 Toxoids; for injection1789 Tramadol1790 Trandolapril1791 Tranexamic acid1792 Tranylcypromine1793 Trastuzumab1794 Travoprost Reprinted as at1 December 2011 Medicines Regulations 1984
1795 Trazodone1796 Trenbolone1797 Treosulphan1798 Treprostinil1799 Trestolone1800 Tretamine1801 Tretinoin1802 Triacetyloleandomycin1803 Triamcinolone; except when specified elsewhere in this sched- 1804 Triamterene1805 Triaziquone1806 Triazolam1807 Trichlormethiazide1808 Trichloroacetic acid; except for external use in medicines con- taining 12.5% or less for the treatment of warts other thananogenital warts 1809 Trichloroethylene1810 Trichodesma africana; at all strengths1811 Triclofos1812 Tricyclamol1813 Tridihexethyl1814 Trifluoperazine1815 Trifluperidol1816 Triflupromazine1817 Trimeprazine; except when specified elsewhere in this sched- 1818 Trimetaphan1819 Trimethoprim1820 Trimipramine1821 Trimustine1822 Trinitrophenol1823 Trioxysalen Medicines Regulations 1984
1824 Triparanol; at all strengths1825 Triple antigen vaccine1826 Triprolidine; except when specified elsewhere in this schedule1827 Triptorelin1828 Troglitazone1829 Trometamol; for injection in medicines containing more than 1830 Tropicamide; except when used in practice by an optometrist registered with the Optometrists and Dispensing OpticiansBoard 1831 Tropisetron1832 Trovafloxacin1833 Troxidone1834 Tryptophan; in medicines containing more than 100 mil- ligrams per recommended daily dose except in parenteralnutrition replacement preparations 1835 Tuberculosis vaccine1836 Tubocurarine1837 Tulobuterol1838 Typhoid vaccine1839 Unoprostone1840 Uracil1841 Urapidil1842 Urethane1843 Urofollitropin1844 Urokinase1845 Ursodeoxycholic acid1846 Ustekinumab1847 Vaccines; except when specified elsewhere in this schedule1848 Vaccinia virus vaccine1849 Valaciclovir1850 Valdecoxib1851 Valganciclovir Reprinted as at1 December 2011 Medicines Regulations 1984
1852 Valnoctamide1853 Valproic acid1854 Valsartan1855 Vancomycin1856 Vardenafil and its structural analogues1857 Varenicline1858 Varicella (chickenpox) vaccine1859 Vasopressin1860 Vecuronium1861 Venlafaxine1862 Verapamil1863 Veratrum spp.
1864 Vernakalant1865 Verteporfin1866 Vidarabine1867 Vigabatrin1868 Vildagliptin1869 Viloxazine1870 Vinblastine1871 Vincamine1872 Vincristine1873 Vindesine1874 Vinflunine1875 Vinorelbine1876 Vinyl ether1877 Virginiamycin1878 Visnadine1879 Vitamin A; for internal use in medicines containing more than 3 milligrams of retinol equivalents per recommended dailydose except in parenteral nutrition replacement preparations;for external use in medicines containing more than 1% Medicines Regulations 1984
1880 Vitamin D; for internal use in medicines containing more than 25 micrograms per recommended daily dose except in par-enteral nutrition replacement preparations 1881 Voriconazole1882 Warfarin1883 Xamoterol1884 Xanthinol nicotinate1885 Ximelagatran1886 Xipamide1887 Yellow fever vaccine1888 Yohimbine1889 Zafirlukast1890 Zalcitabine1891 Zaleplon1892 Zanamivir1893 Zidovudine1894 Zimeldine1895 Zinc; for internal use in medicines containing more than 25 milligrams per recommended daily dose; except for internaluse in medicines containing 50 milligrams or less and morethan 25 milligrams per recommended daily dose in packs thathave received the consent of the Minister or the Director-Gen-eral to their distribution as general sale medicines and that aresold in the manufacturer's original pack and when labelledwith a statement that the product may be dangerous if takenin large amounts or for long periods; except in parenteral nu-trition replacement preparations 1896 Ziprasidone1897 Zoledronic acid1898 Zolmitriptan; except when specified elsewhere in this schedule1899 Zolpidem1900 Zonisamide1901 Zopiclone1902 Zoxazolamine Reprinted as at1 December 2011 Medicines Regulations 1984
1903 Zuclopenthixol Restricted medicines Adrenaline; in medicines containing 1% or less and more than0.02% Alclometasone; for dermal use in medicines containing 0.05%or less and in packs containing not more than 30 grams thathave received the consent of the Minister or the Director-Gen-eral to their distribution as restricted medicines and that aresold in the manufacturer's original pack Aminophylline; for oral use in liquid form in medicines con-taining 2% or less Amorolfine; for external use in medicines containing morethan 0.25% Aspirin; in slow-release forms; in enteric coated forms con-taining more than 300 milligrams per dose form; except whenspecified elsewhere in this schedule Azatadine; for oral use in adults and children over 2 years ofage Azelastine; in medicines for ophthalmic use containing 0.05%or less Brompheniramine; for oral use in medicines for adults andchildren over 2 years of age; except when specified elsewherein this schedule Buclizine; for oral use Butoconazole; for vaginal use Chloramphenicol; for ophthalmic use; except when sold inpractice by an optometrist registered with the Optometrists andDispensing Opticians Board Chlorbutol; in medicines containing more than 5% Chlorpheniramine; for oral use in medicines for adults andchildren over 2 years of age; except when specified elsewherein this schedule Medicines Regulations 1984
Ciclopirox; for external use in medicines containing more than2% Cimetidine; in medicines that have received the consent ofthe Minister or the Director-General to their distribution asrestricted medicines and that are sold in the manufacturer'soriginal pack containing not more than 14 days' supply Clemastine; for oral use Clobetasone; for dermal use in medicines containing 0.05% orless and in packs containing not more than 30 grams that havereceived the consent of the Minister or the Director-Generalto their distribution as restricted medicines and that are sold inthe manufacturer's original pack Clotrimazole; for vaginal use Codeine; in medicines for oral use containing not more than 15milligrams of codeine per solid dosage unit or per dose of li-quid with a maximum daily dose not exceeding 100 milligramsof codeine, when combined with 1 or more active ingredientsin such a way that the substance cannot be recovered by read-ily applicable means or in a yield that would constitute a riskto health, for use as an analgesic and when sold in a pack ofnot more than 5 days' supply, approved by the Minister or theDirector-General for distribution as a restricted medicine Cyclizine; for oral use Cyproheptadine; for oral use Dexchlorpheniramine; for oral use in medicines for adults andchildren over 2 years of age; except when specified elsewherein this schedule Di-iodohydroxy quinoline; for vaginal use Diclofenac; in solid dose form in medicines containing 25 mil-ligrams or less and more than 12.5 milligrams per dose formin packs containing not more than 30 tablets or capsules Dimenhydrinate; for oral use in medicines for adults and chil-dren over 2 years of age; except when specified elsewhere inthis schedule Dimethindene; for oral use Reprinted as at1 December 2011 Medicines Regulations 1984
Diphenhydramine; for oral use in medicines for adults andchildren over 2 years of age; except when specified elsewherein this schedule Doxylamine; for oral use in medicines for adults and childrenover 2 years of age; except when specified elsewhere in thisschedule Econazole; for vaginal use Erythrityl tetranitrate Famciclovir; in tablets containing 500 milligrams or less whensold in a pack approved by the Minister or the Director-Gen-eral for distribution as a restricted medicine Fluconazole; for oral use in medicines that have received theconsent of the Minister or the Director-General to their distri-bution as restricted medicines and that are sold in the manu-facturer's original pack containing 150 milligrams or less as asingle dose for the treatment of vaginal candidiasis Fluorides; for external use in liquid form in medicines con-taining 5.5 grams or less and more than 1 gram per litre or perkilogram and when sold in packs approved by the Minister orthe Director-General for distribution as restricted medicines;for external use in non-liquid form in medicines containing5.5 grams or less and more than 1 gram per litre or per kilo-gram, except in medicines containing 1.5 grams or less andmore than 1 gram per litre or per kilogram; except when sup-plied to a dental professional registered with the Dental Coun-cil Glucagon; except in medicines containing 100 micrograms orless per litre or per kilogram Glyceryl trinitrate; for oral or sublingual use; for rectal use Glycopyrronium; except for injection Guaiphenesin; for oral use in modified-release form witha maximum recommended daily dose of not more than 2.4grams sold in a pack containing more than 5 days' supply but Medicines Regulations 1984
not more than 30 days' supply approved by the Minister orthe Director-General for distribution as a restricted medicine Haemophilus influenzae vaccine; in oral vaccines for the pro-phylaxis of bacterial complications of colds Hydrocortisone and hydrocortisone acetate but no other estersof hyrocortisone; for dermal use in medicines containing 1%or less but more than 0.5% by weight of hydrocortisone basewith no other active ingredient except an antifungal and in aquantity of 30 grams or less or 30 millilitres or less per con-tainer; in rectal medicines containing 1% or less but more than0.5% by weight of hydrocortisone base and in combinationwith a local anaesthetic and in a quantity of 35 grams or lessper container or up to 12 suppositories per pack Hyoscine butylbromide; for oral use in medicines containingnot more than 10 milligrams per dose form and in packs con-taining not more than 20 tablets or capsules Ibuprofen; for oral use in tablets or capsules containing upto 400 milligrams per dose form and in packs containing notmore than 50 dose units and that have received the consentof the Minister or the Director-General to their distribution asrestricted medicines and that are sold in the manufacturer'soriginal pack labelled for use by adults and children over 12years of age Inositol nicotinate Isoconazole; for vaginal use Ketoprofen; in solid dose form containing 25 milligrams orless per dose form in packs of not more than 30 capsules ortablets Lansoprazole; in tablets or capsules containing 15 milligramsor less when sold in a pack approved by the Minister or theDirector-General for distribution as a restricted medicine Levonorgestrel; in medicines for use as emergency post-coitalcontraception when in packs containing not more than 1.5 mil-ligrams except when sold by nurses recognised by their pro-fessional body as having competency in the field of sexual andreproductive health Reprinted as at1 December 2011 Medicines Regulations 1984
Macrogols; in oral preparations for bowel cleansing prior todiagnostic, medical, or surgical procedures Malathion; for external use in medicines containing more than2% Mannityl hexanitrate Mepyramine; for oral use in medicines for adults and childrenover 2 years of age Methdilazine; for oral use Metoclopramide; when compounded with paracetamol inpacks of not more than 10 tablets or capsules for the treatmentof nausea associated with migraine Miconazole; for the treatment of oral candidiasis; for vaginaluse Nicotinic acid except nicotinamide; in medicines containing250 milligrams or less but more than 100 milligrams per doseform Nicotinyl alcohol; in medicines containing more than 100 mil-ligrams per dose form Nystatin; for the treatment of oral candidiasis; for vaginal use Omeprazole; in tablets or capsules containing 20 milligramsor less when sold in a pack approved by the Minister or theDirector-General for distribution as a restricted medicine Orlistat; in medicines for weight control containing 120 mil-ligrams or less per dose form Oxiconazole; for vaginal use Pantoprazole; in tablets or capsules containing 20 milligramsor less of pantoprazole when sold in a pack approved by theMinister or the Director-General for distribution as a restrictedmedicine Pheniramine; for oral use in medicines for adults and childrenover 2 years of age Pneumococcal vaccine; in oral vaccines for the prophylaxis ofbacterial complications of colds Podophyllotoxin; for external use for the treatment of wartsother than anogenital warts in medicines containing 1% or less Medicines Regulations 1984
and more than 0.5%; except in medicines containing 1 mil-ligram or less of podophyllin per litre or per kilogram Podophyllum emodi; for external use for the treatment of wartsother than anogenital warts in medicines containing 20% orless and more than 10% of podophyllin; except in medicinescontaining 1 milligram or less of podophyllin per litre or perkilogram Podophyllum peltatum; for external use for the treatment ofwarts other than anogenital warts in medicines containing 20%or less and more than 10% of podophyllin; except in medicinescontaining 1 milligram or less of podophyllin per litre or perkilogram Prochlorperazine; in packs containing not more than 10 tabletsor capsules for the treatment of nausea associated with mi-graine Promethazine; for oral use in medicines for adults and childrenover 2 years of age; except when specified elsewhere in thisschedule Rizatriptan; for oral use in medicines for the acute relief ofmigraine attacks with or without aura in patients who have astable, well-established pattern of symptoms, when in waferscontaining 5 milligrams or less per wafer and when sold ina pack containing not more than 2 wafers approved by theMinister or the Director-General for distribution as a restrictedmedicine Salicylic acid; except in medicines for dermal use containing40% or less Sodium phosphate; in oral preparations for bowel cleansingprior to diagnostic, medical, or surgical procedures Sodium picosulphate; in oral preparations for bowel cleansingprior to diagnostic, medical, or surgical procedures Staphyloccocus aureus vaccine; in oral vaccines for the pro-phylaxis of bacterial complications of colds Reprinted as at1 December 2011 Medicines Regulations 1984
Stramonium; for oral use in liquid form; in solid dose formin medicines containing more than 0.3 milligrams per dose ormore than 1.2 milligrams per recommended daily dose Streptococcus beta-haemolyticus vaccine; in oral vaccines forthe prophylaxis of bacterial complications of colds Sulfacetamide; for ophthalmic use in medicines containing10% or less Sumatriptan; for oral use in medicines for the acute relief ofmigraine attacks with or without aura in patients who have astable, well-established pattern of symptoms when in tabletscontaining 50 milligrams or less per tablet and when sold in apack containing not more than 2 tablets that has received theconsent of the Minister or the Director-General to its sale as arestricted medicine Theophylline; in liquid form for oral use in medicines contain-ing 2% or less Tioconazole; for vaginal use Triamcinolone; for buccal use in medicines containing 0.1% orless of triamcinolone acetonide and in pack sizes of 5 gramsor less Trimeprazine; for oral use in adults and children over 2 yearsof age; except when specified elsewhere in this schedule Triprolidine; for oral use in medicines for adults and childrenover 2 years of age; except when specified elsewhere in thisschedule Zolmitriptan; in a pre-filled nasal spray device containing notmore than 5 milligrams of zolmitriptan, for the acute relief ofmigraine attacks with or without aura in patients who have astable, well-established pattern of symptoms and when sold ina pack of not more than 2 devices approved by the Minister orthe Director-General for distribution as a restricted medicine Pharmacy-only medicines 8-hydroxyquinoline and its non-halogenated derivatives; inmedicines containing more than 1% of such substances Medicines Regulations 1984
Acetic acid and preparations containing more than 80% ofacetic acid (CH COOH); excluding its salts and derivatives Acetylcysteine; for oral use in medicines containing more than1 gram per recommended daily dose Aciclovir; for external use for the treatment of herpes labialisexcept in medicines containing 5% or less and in tubes con-taining 10 grams or less Aconitum spp.; for oral use in packs containing 0.2 milligramsor less and more than 0.02 milligrams of total alkaloids; fordermal use in concentrations of 0.02% or less and in packs con-taining 0.2 milligrams or less and more than 0.02 milligramsof total alkaloids Aloes; for internal use; except when obtained solely from themucilaginous gel of the leaf Amethocaine; for external use in medicines containing 10%or less and more than 2% Amorolfine; for external use in medicines containing 0.25%or less except in medicines for tinea pedis only Antazoline; for ophthalmic use except when sold in practiceby an optometrist registered with the Optometrists and Dis-pensing Opticians Board Atropa belladonna; for external use in medicines containing0.03% or less of the alkaloids of belladonna; for oral use in li-quid form in medicines containing 0.03% or less and 0.3 mil-ligrams or less per dose and not more than 1.2 milligrams perrecommended daily dose of the alkaloids of belladonna or insolid dose form in medicines containing 0.3 milligrams or lessper dose form and not more than 1.2 milligrams per recom-mended daily dose of the alkaloids of belladonna Atropine; for oral use in liquid form in medicines containing0.03% or less and 0.3 milligrams or less per dose and not morethan 1.2 milligrams per recommended daily dose or in soliddose form in medicines containing 0.3 milligrams or less perdose form and not more than 1.2 milligrams per recommended Reprinted as at1 December 2011 Medicines Regulations 1984
daily dose; in medicines containing atropine sulphate for thetreatment of organophosphorus poisoning either in packs ofnot more than 20 dose units containing 0.6 milligrams or lessper dose unit or in injections in packs of not more than 5vials containing 0.6 milligrams per millilitre; except whensold as an antidote in a device designed for self-injection fromoutlets licensed to sell organophosphorus poisons; except inmedicines containing 300 micrograms or less per litre or perkilogram Azelaic acid; for dermal use Azelastine; for nasal use Beclomethasone; for the treatment or prophylaxis of allergicrhinitis in adults and children over 12 years of age when inaqueous nasal sprays delivering up to 50 micrograms per ac-tuation when the maximum recommended daily dose is nogreater than 400 micrograms and the medicine has receivedthe consent of the Minister or the Director-General to its dis-tribution as a pharmacy-only medicine Benzocaine; in preparations for topical use, other than eyedrops, containing 10% or less of total anaesthetic substancesexcept in dermal preparations containing 2% or less of totalanaesthetic substances; in divided preparations containing 200milligrams or less of total anaesthetic substances per dosageunit except in lozenges containing 30 milligrams or less oftotal anaesthetic substances per dosage unit Benzoyl peroxide; for external use in medicines containingmore than 5% and not more than 10% Benzydamine; for external use except for dermal use Bifonazole; for dermal use except in medicines for tinea pedisonly or in shampoos containing 1% or less Brompheniramine; for oral use in medicines for adults andchildren over 6 years of age when combined in the same con-tainer with 1 or more other therapeutically active ingredients Medicines Regulations 1984
either when in the bedtime dose of a day/night pack containingbrompheniramine or when at least 1 of the other active ingre-dients is a sympathomimetic decongestant Budesonide; for the treatment or prophylaxis of allergic rhini-tis in adults and children over 12 years of age when in aque-ous nasal sprays delivering up to 50 micrograms per actuationand when the maximum recommended daily dose is no greaterthan 400 micrograms and the medicine has received the con-sent of the Minister or the Director-General to its distributionas a pharmacy-only medicine Carbetapentane; in medicines containing more than 0.5% Cetirizine; for oral use Chlorbutol; in medicines containing 5% or less and more than0.5% Chloroform; in medicines other than for anaesthesia contain-ing more than 0.5% Chlorpheniramine; for oral use in medicines for adults andchildren over 6 years of age when combined in the same con-tainer with 1 or more other therapeutically active ingredientseither when in the bedtime dose of a day/night pack containingchlorpheniramine or when at least 1 of the other active ingre-dients is a sympathomimetic decongestant Ciclopirox; for external use in medicines containing 2% or lessexcept in medicines for tinea pedis only Cinchocaine; for external use in medicines containing 0.5% orless Clotrimazole; for external use except in medicines for tineapedis only Cocaine; in medicines for oral use, containing not more than0.1% of cocaine when combined with 1 or more active ingre-dients, in such a way that the substance cannot be recovered byreadily applicable means or in a yield that would constitute a Reprinted as at1 December 2011 Medicines Regulations 1984
risk to health and when sold in a pack approved by the Minis-ter or the Director-General for distribution as a pharmacy-onlymedicine Codeine; in medicines for oral use, containing not more than15 milligrams of codeine per solid dosage unit or per dose of li-quid with a maximum daily dose not exceeding 100 milligramsof codeine, when combined with 1 or more active ingredientsin such a way that the substance cannot be recovered by read-ily applicable means or in a yield that would constitute a riskto health, for the treatment of the symptoms of cough and coldand when sold in a pack of not more than 6 days' supply, ap-proved by the Minister or the Director-General for distributionas a pharmacy-only medicine Creosote; in medicines containing more than 10% Cresols; in medicines containing more than 3% Datura spp.; for oral use in liquid form in medicines contain-ing 0.03% or less and 0.3 milligrams or less per dose and notmore than 1.2 milligrams per recommended daily dose of totalsolanaceous alkaloids; in solid dose form in medicines con-taining 0.3 milligrams or less per dose form and not more than1.2 milligrams per recommended daily dose of total solana-ceous alkaloids Delphinium staphisagria; in medicines containing more than0.2% Desloratadine; for oral use Dexchlorpheniramine; for oral use in medicines for adults andchildren over 6 years of age when combined in the same con-tainer with 1 or more other therapeutically active ingredientseither when in the bedtime dose of a day/night pack contain-ing dexchlorpheniramine or when at least 1 of the other activeingredients is a sympathomimetic decongestant Dextromethorphan; in liquid form containing more than0.25% or in solid dose form containing more than 15 mil-ligrams per dose form when in packs containing not more than600 milligrams and with a recommended daily dose of not Medicines Regulations 1984
more than 120 milligrams; in medicines for the treatment ofthe symptoms of cough and cold in children aged 6–12 years Dibrompropamidine; for ophthalmic use except when sold inpractice by an optometrist registered with the Optometrists andDispensing Opticians Board Diclofenac; in solid dose form in medicines containing 12.5milligrams or less per dose form in packs containing not morethan 30 tablets or capsules and with a recommended daily doseof not more than 75 milligrams Diphenoxylate; in liquid form containing in each millilitre notmore than 0.5 milligrams of diphenoxylate calculated as baseand not less than 5 micrograms of Atropine sulphate; in soliddose form containing not more than 2.5 milligrams of diphe-noxylate calculated as base and not less than 5 micrograms ofatropine sulphate Dimenhydrinate; for oral use in a sealed container of not morethan 10 tablets or capsules for the prevention or treatment ofmotion sickness in adults or children over 2 years of age exceptwhen sold at a transport terminal or aboard a ship or aircraft Diphenhydramine; for oral use in medicines for adults andchildren over 6 years of age when combined in the same con-tainer with 1 or more other therapeutically active ingredientseither when in the bedtime dose of a day/night pack containingdiphenhydramine or when at least 1 of the other active ingre-dients is a sympathomimetic decongestant; for oral use in asealed container of not more than 10 tablets or capsules forthe prevention or treatment of motion sickness in adults andchildren over 2 years of age except when sold at a transportterminal or aboard a ship or aircraft Doxylamine; for oral use in medicines for adults and childrenover 6 years of age when combined in the same container with1 or more other therapeutically active ingredients either whenin the bedtime dose of a day/night pack containing doxylamineor when at least 1 of the other active ingredients is a sympath-omimetic decongestant Reprinted as at1 December 2011 Medicines Regulations 1984
Duboisia leichhardtii; for oral use in liquid form in medicinescontaining 0.03% or less and 0.3 milligrams or less per doseand not more than 1.2 milligrams per recommended dailydose of total solanaceous alkaloids; in solid dose form inmedicines containing 0.3 milligrams or less per dose form andnot more than 1.2 milligrams per recommended daily dose oftotal solanaceous alkaloids Duboisia myoporides; for oral use in liquid form in medicinescontaining 0.03% or less and 0.3 milligrams or less per doseand not more than 1.2 milligrams per recommended dailydose of total solanaceous alkaloids; in solid dose form inmedicines containing 0.3 milligrams or less per dose form andnot more than 1.2 milligrams per recommended daily dose oftotal solanaceous alkaloids Econazole; for dermal use except in medicines for tinea pedisonly Ether; in medicines containing more than 10% Etofenamate; for external use Famotidine; in medicines that have received the consent of theMinister or the Director-General to their distribution as phar-macy-only medicines and that are sold in the manufacturer'soriginal pack containing not more than 14 days' supply Felbinac; for external use Fexofenadine; for oral use except when in capsules contain-ing 60 milligrams or less of fexofenadine hydrochloride orin tablets containing 120 milligrams or less of fexofenadinehydrochloride when sold in a pack approved by the Minis-ter or the Director-General for distribution as a general salesmedicine Fluorides; for internal use in medicines containing 0.5 mil-ligrams or less per dose unit; except in parenteral nutritionreplacement preparations; for external use in liquid form inmedicines containing 1 gram or less per litre or per kilogramand when sold in packs approved by the Minister or the Dir-ector-General for distribution as pharmacy-only medicines ex- Medicines Regulations 1984
cept in medicines containing 220 milligrams or less per litreor per kilogram and in packs containing not more than 120milligrams of total fluoride; except when supplied to any den-tal professional registered with the Dental Council; except inmedicines containing 15 milligrams or less per litre or per kilo-gram Flurbiprofen; in locally acting oromucosal preparations con-taining 10 milligrams or less per dosage unit Fluticasone; for the treatment or prophylaxis of allergic rhini-tis in adults and children over 12 years of age when in aque-ous nasal sprays delivering up to 50 micrograms per actuationwhen the maximum recommended daily dose is no greaterthan 200 micrograms and the medicine has received the con-sent of the Minister or the Director-General to its distributionas a pharmacy-only medicine Folic acid; for oral use in medicines containing more than 500micrograms per recommended daily dose Folinic acid; for oral use in medicines containing more than500 micrograms per recommended daily dose Formaldehyde; in medicines containing more than 5% Gelsemium sempervirens; except in medicines containing 1milligram or less per litre or per kilogram Hexachlorophane; in medicines containing 3% or less butmore than 0.75% Hydrocortisone and hydrocortisone acetate but no other es-ters of hydrocortisone; for dermal use in medicines containing0.5% or less by weight of hydrocortisone base with no otheractive ingredient except an antifungal and in a quantity of 30grams or less or 30 millilitres or less per container; in rectalmedicines containing 0.5% or less by weight of hydrocorti-sone base and in combination with a local anaesthetic and in aquantity of 35 grams or less per container or 12 suppositoriesor fewer per pack Hydrocyanic acid; for oral use in packs containing 5 mil-ligrams or less and more than 0.5 milligrams; except in Reprinted as at1 December 2011 Medicines Regulations 1984
medicines containing 1 microgram or less per litre or perkilogram Hydroquinone; for external use in medicines containing 2% orless except in hair preparations containing 1% or less Hyoscine; for transdermal use in medicines containing 2 mil-ligrams or less of total solanaceous alkaloids per dose unit;for oral use in liquid form in medicines containing 0.03% orless and 0.3 milligrams or less per dose and not more than 1.2milligrams per recommended daily dose of total solanaceousalkaloids; in solid dose form in medicines containing 0.3 mil-ligrams or less per dose form and not more than 1.2 milligramsper recommended daily dose of total solanaceous alkaloids Hyoscyamine; for external use in medicines containing 0.03%or less of total solanaceous alkaloids; for oral use in liquidform in medicines containing 0.03% or less and 0.3 milligramsor less per dose and not more than 1.2 milligrams per recom-mended daily dose of total solanaceous alkaloids; in solid doseform in medicines containing 0.3 milligrams or less per doseform and not more than 1.2 milligrams per recommended dailydose of total solanaceous alkaloids Hyoscyamus niger; for oral use in liquid form in medicinescontaining 0.03% or less and 0.3 milligrams or less per doseand not more than 1.2 milligrams per recommended dailydose of total solanaceous alkaloids or in solid dose form inmedicines containing 0.3 milligrams or less per dose formand not more than 1.2 milligrams per recommended dailydose except in packs containing 30 micrograms or less of totalsolanaceous alkaloids Ibuprofen; for oral use in liquid form in packs containing notmore than 4 grams in medicines that have received the con-sent of the Minister or the Director-General to their distri-bution as pharmacy-only medicines and that are sold in themanufacturer's original pack; for oral use in solid dose formcontaining not more than 200 milligrams per dose form andwith a recommended daily dose of not more than 1.2 gramsand in packs containing not more than 100 dose units andwhen in medicines that have received the consent of the Min- Medicines Regulations 1984
ister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's ori-ginal pack; except in packs containing 200 milligrams or lessper oral solid dose form and not more than 25 dose units perpack in medicines that have received the consent of the Minis-ter or the Director-General to their distribution as general salemedicines and that are sold in the manufacturer's original pack Indomethacin; for external use in medicines containing 1% orless; except in medicines containing 1 milligram or less perlitre or per kilogram Iodine; for external use in medicines containing more than2.5%; for internal use in medicines containing 300 micro-grams or more per recommended daily dose Ipecacuanha; in medicines containing 0.2% or less of emetineand 40 micrograms or more of ipecacuanha alkaloids per rec-ommended dose for the treatment of the symptoms of coughand cold in children aged 6–12 years Ipratropium; for nasal use Iron; for oral use either in medicines containing more than24 milligrams per recommended daily dose or in medicinescontaining more than 5 milligrams per dose unit and more than750 milligrams of iron per pack; except in parenteral nutritionreplacement preparations Isoconazole; for dermal use Isopropamide; for dermal use in preparations containing 2%or less Ketoconazole; for dermal use except in medicines for tineapedis only or in medicines for treatment of the scalp containing1% or less Ketotifen; for ophthalmic use in medicines containing 0.025%or less except when sold in practice by an optometrist regis-tered with the Optometrists and Dispensing Opticians Board Reprinted as at1 December 2011 Medicines Regulations 1984
Leucovorin; in medicines containing more than 500 micro-grams per recommended daily dose Levocabastine; for nasal use; for ophthalmic use exceptwhen sold in practice by an optometrist registered with theOptometrists and Dispensing Opticians Board Levocetirizine; for oral use Lignocaine; for urethral use; for external use in medicines con-taining 10% or less and more than 2% Lindane; for external use in medicines containing 2% or less Lithium; for dermal use in medicines containing 1% or lessbut more than 0.01%; except when present as an excipient indermal medicines containing 0.25% or less Lobelia inflata; except in medicines for smoking or burning Lobeline; except when in medicines for smoking or burning Lodoxamide; for ophthalmic use except when sold in practiceby an optometrist registered with the Optometrists and Dis-pensing Opticians Board Loperamide; in packs containing not more than 20 tablets orcapsules; except in divided solid dosage forms for oral usecontaining 2 milligrams or less of loperamide per dosage formwhen sold in a pack containing not more than 8 dosage formsapproved by the Minister or the Director-General for distribu-tion as a general sales medicine for the symptomatic treatmentof acute non-specific diarrhoea Loratadine; for oral use Meclozine; in a sealed container of not more than 12 tabletsor capsules for the prevention or treatment of travel sicknessexcept when sold at a transport terminal or aboard a ship oraircraft Mefenamic acid; in solid dose form in packs containing notmore than 30 tablets or capsules for the treatment of dysmen-orrhoea Mepyramine; for dermal use Mercuric oxide; for ophthalmic use Medicines Regulations 1984
Mercury; for external use in medicines containing 0.5% or less Methoxamine; for external use in medicines containing morethan 1% Miconazole; for external use except in medicines for tineapedis only Minoxidil; for dermal use in medicines containing 5% or less Mometasone; for the treatment or prophylaxis of allergic rhini-tis in adults and children over 12 years of age when in aque-ous nasal sprays delivering up to 50 micrograms per actuationand when the maximum recommended daily dose is no greaterthan 200 micrograms and the medicine has received the con-sent of the Minister or the Director-General to its distributionas a pharmacy-only medicine Morphine; in medicines for oral use containing not more than0.2% of morphine, when combined with 1 or more active in-gredients in such a way that the substance cannot be recoveredby readily applicable means or in a yield that would constitutea risk to health, when sold in a pack approved by the Minis-ter or the Director-General for distribution as a pharmacy-onlymedicine Naphazoline; except for ophthalmic use when sold in practiceby an optometrist registered with the Optometrists and Dis-pensing Opticians Board Naproxen; in solid dose form containing 250 milligrams orless per dose form in packs of not more than 30 tablets orcapsules Nicotine; for inhalation except when sold from a smoking ces-sation clinic run under the auspices of a registered medicalpractitioner, nurse, pharmacist, or psychologist Nizatidine; in medicines that have received the consent of theMinister or the Director-General to their distribution as phar-macy-only medicines and that are sold in the manufacturer'soriginal pack containing not more than 14 days' supply Reprinted as at1 December 2011 Medicines Regulations 1984
Nystatin; for dermal use Omeprazole; in divided solid dosage forms for oral use con-taining 20 milligrams or less, with a maximum daily dose of20 milligrams in a pack size of up to 14 dosage units, for theshort-term symptomatic relief of gastric reflux-like symptomsin sufferers aged 18 years and over, when sold in a pack ap-proved by the Minister or the Director-General for distributionas a pharmacy-only medicine Opium; in medicines for oral use containing not more than0.2% of morphine, when combined with 1 or more active in-gredients in such a way that the substance cannot be recoveredby readily applicable means, or in a yield that would constitutea risk to health, when sold in a pack approved by the Minis-ter or the Director-General for distribution as a pharmacy-onlymedicine Oxetacaine; for internal use Oxiconazole; for dermal use except in medicines for tineapedis only Oxymetazoline; except for nasal use when sold at an airport;except for ophthalmic use when sold in practice by an op-tometrist registered with the Optometrists and Dispensing Op-ticians Board Papaverine; except for injection Paracetamol; in liquid form; in suppositories; in tablets or cap-sules containing 500 milligrams or less and in packs contain-ing more than 10 grams; in slow-release forms containing 665milligrams or less and more than 500 milligrams; in powderform containing not more than 1 gram per sachet and morethan 10 grams per pack Paraformaldehyde; in medicines containing more than 5% Penciclovir; for external use for the treatment of herpes labialis Phenazone; for external use Medicines Regulations 1984
Pheniramine; for ophthalmic use except when sold in practiceby an optometrist registered with the Optometrists and Dis-pensing Opticians Board; for oral use in medicines for adultsand children over 6 years of age when combined in the samecontainer with 1 or more other therapeutically active ingredi-ents either when in the bedtime dose of a day/night pack con-taining pheniramine or when at least 1 of the other active in-gredients is a sympathomimetic decongestant Phenol; in medicines other than for injection containing morethan 3% Phenylephrine; for nasal use in medicines containing morethan 1%; for ophthalmic use in medicines containing 5% orless and more than 1%; for oral use in medicines containingmore than 50 milligrams per recommended daily dose or inpacks containing more than 250 milligrams of phenylephrineper pack; in medicines for the treatment of the symptoms ofcough and cold in children aged 6–12 years Pholcodine; in medicines for oral use containing not more than15 milligrams of pholcodine per solid dosage unit or per doseof liquid with a maximum daily dose not exceeding 100 mil-ligrams of pholcodine, when combined with 1 or more activeingredients in such a way that the substance cannot be recov-ered by readily applicable means, or in a yield that would con-stitute a risk to health, when sold in a pack approved by theMinister or the Director-General for distribution as a phar-macy-only medicine Podophyllotoxin; for external use for the treatment of wartsother than anogenital warts in medicines containing 0.5% orless; except in medicines containing 1 milligram or less ofpodophyllin per litre or per kilogram Podophyllum emodi; for external use for the treatment of wartsother than anogenital warts in medicines containing 10% orless of podophyllin; except in medicines containing 1 mil-ligram or less of podophyllin per litre or per kilogram Reprinted as at1 December 2011 Medicines Regulations 1984
Podophyllum peltatum; for external use for the treatment ofwarts other than anogenital warts in medicines containing 10%or less of podophyllin; except in medicines containing 1 mil-ligram or less of podophyllin per litre or per kilogram Potassium; for internal use: in slow-release or enteric coatedforms; in medicines containing more than 100 milligrams perrecommended dose except in medicines for oral rehydrationtherapy, parenteral nutrition replacement, or dialysis; exceptin glucosamine sulphate complexed products containing 600milligrams or less of potassium chloride per recommendeddose Potassium chlorate; except in medicines containing 10% orless Prilocaine; for dermal use in medicines containing 10% or lessof local anaesthetic substances Procyclidine; for dermal use in medicines containing 5% orless Promethazine; for oral use in medicines for adults and childrenover 6 years of age when combined in the same container with1 or more other therapeutically active ingredients either whenin the bedtime dose of a day/night pack containing promet-hazine or when at least 1 of the other active ingredients is asympathomimetic decongestant; for oral use in a sealed con-tainer of not more than 10 tablets or capsules for the preventionor treatment of motion sickness in adults and children over 2years of age except when sold at a transport terminal or aboarda ship or aircraft Propamidine; for ophthalmic use except when sold in practiceby an optometrist registered with the Optometrists and Dis-pensing Opticians Board Pseudoephedrine; in medicines for oral use containing notmore than 60 milligrams of pseudoephedrine per solid dosageunit or per dose of liquid, and containing either a single in-gredient or when combined with 1 or more active ingredients,when sold in a pack containing not more than 1.8 grams Medicines Regulations 1984
of pseudoephedrine, approved by the Minister or the Dir-ector-General for distribution as a pharmacy-only medicine Pyrethrins; in medicines containing more than 10% Pyrithione zinc; except in medicines for treatment of the scalpcontaining 2% or less Ranitidine; in medicines that have received the consent of theMinister or the Director-General to their distribution as phar-macy-only medicines and that are sold in the manufacturer'soriginal pack containing not more than 14 days' supply; ex-cept in medicines containing 150 milligrams or less per doseunit that have received the consent of the Minister or the Dir-ector-General to their distribution as general sale medicinesand that are sold in the manufacturer's original pack contain-ing not more than 7 days' supply Selenium; for oral use in medicines containing 300 micro-grams or less and more than 150 micrograms per recom-mended daily dose; for external use except in medicinescontaining 3.5% or less of selenium sulphide Silver; except in oral solutions containing 0.3% or less or othermedicines containing 1% or less Silver sulfadiazine; for external use in pack sizes of 50 gramsor less Sodium cromoglycate; for nasal use; for ophthalmic use ex-cept when sold in practice by an optometrist registered withthe Optometrists and Dispensing Opticians Board Sodium nitrite; except for use as an excipient Sodium picosulphate; in oral laxative preparations Squill; in medicines containing more than 1% Stramonium; for oral use in liquid form in medicines contain-ing 0.03% or less and 0.3 milligrams or less per dose and notmore than 1.2 milligrams per recommended daily dose of totalsolanaceous alkaloids; in solid dose form in medicines con- Reprinted as at1 December 2011 Medicines Regulations 1984
taining 0.3 milligrams or less per dose form and not more than1.2 milligrams per recommended daily dose of total solana-ceous alkaloids Sulconazole; for dermal use Sulfadiazine, silver; for external use in pack sizes of 50 gramsor less Terbinafine; for dermal use except in medicines for tinea pedisonly Tetrahydrozoline; except for ophthalmic use when sold inpractice by an optometrist registered with the Optometristsand Dispensing Opticians Board Tioconazole; for dermal use except in medicines for tineapedis only Triamcinolone; for the treatment or prophylaxis of allergicrhinitis in adults and children over 12 years of age and whenin aqueous nasal sprays delivering up to 55 micrograms peractuation when the maximum recommended daily dose is nogreater than 220 micrograms and the medicine has receivedthe consent of the Minister or the Director-General to its dis-tribution as a pharmacy-only medicine Trimeprazine; for oral use in medicines for adults and chil-dren over 6 years of age when combined in the same con-tainer with 1 or more other therapeutically active ingredientseither when in the bedtime dose of a day/night pack contain-ing trimeprazine or when at least 1 of the other therapeuticallyactive ingredients is a sympathomimetic decongestant Triprolidine; for oral use in medicines for adults and childrenover 6 years of age when combined in the same container with1 or more other therapeutically active ingredients either whenin the bedtime dose of a day/night pack containing triprolidineor when at least 1 of the other active ingredients is a sympath-omimetic decongestant Medicines Regulations 1984
Xylenols; in medicines containing more than 3% Xylometazoline; except for nasal use when sold at an airport;except for ophthalmic use when sold in practice by an op-tometrist registered with the Optometrists and Dispensing Op-ticians Board Zinc chloride; for dermal use in medicines containing morethan 5% Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 2
Application for licence to manufacture, hawk, sell, or pack medicine [Before completing this form you should make yourself familiar withthe provisions of the and the Medicines Regula-tions 1984, especially those parts that deal with licences.
This form may be used to apply for licences to manufacture, pack,sell, or hawk medicines. It is divided into 7 parts. Every applicantmust complete either Part 1 or Part 2, and must also complete atleast one of Parts 3, 4, 5, 6, and 7.
Every application must be accompanied by the prescribed fee foreach licence applied for (viz, , Medicines Regulations1984).]The form must be completed in type, or in block capitals.
[To be completed where the applicant is an individual applying for a
licence on his own behalf.]
Name of applicant: [surname] [first names]
I am a New Zealand resident: Yes/No
Date of birth: [day/month/year]
Address (home):
Name of business:
Street address of business premises:
Postal address:General nature of business:Position of applicant (for example, "owner", "manager" etc): Have you previously held a licence to manufacture, pack, sell, or
hawk medicines? Yes/No
Medicines Regulations 1984
If yes give details:
Have you ever been declined, or had revoked, a licence to manufac-
ture, pack, sell, or hawk medicines? Yes/No
If yes give details:
[To be completed where the applicant is an officer of a body corporate
applying for a licence on behalf of the body corporate.]
Name of body corporate:
The body corporate is incorporated in New Zealand Yes/No
Street address of body corporate:
Postal address:General nature of business of body corporate: Name of person completing this form: [surname] [first names] Position in body corporate of person completing form: Details of persons nominated to be responsible persons under the Reprinted as at1 December 2011 Medicines Regulations 1984
Date of birth
Position in body corporate
Have any of the above nominees ever been declined, or had revoked,
a licence to manufacture, pack, sell, or hawk medicines? Yes/No
If yes give details:
Have any of the above nominees ever been a licensee or respon-
sible person under the Restricted Drugs Act 1960 or the ? Yes/No
If yes give details:
Application to manufacture medicines I hereby make application for a licence to manufacture the medicineslisted below (attach extra list if insufficient space provided here). In-dicate (by reference to one of the following paragraphs) which of thefollowing classes the medicines come within:(a) antibiotics, or preparations of antibiotics: vaccines and sera: sterile preparations: hormones and steroid preparations: preparations, other than vitamins, having a dose of 5 mil-ligrams or less per unit dose: antineoplastic agents and immunosuppressant agents otherthan steroid preparations: other medicines not included in paragraphs (a) to (f), above.
Medicines Regulations 1984
Trade name of medicine
Premises where manufacture (including packing and labelling) of themedicines will be carried out: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a bodycorporate):Date: Application to pack medicines I hereby make application for a licence to pack the medicines listedbelow (attach extra list if insufficient space provided here). Indicatein the third column whether the medicine is a prescription medicine,restricted medicine, or pharmacy-only medicine.
Trade name of medicine
Reprinted as at1 December 2011 Medicines Regulations 1984
Premises where packing and labelling will be carried out: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a bodycorporate):Date: Application to sell medicines by wholesale I hereby make application to sell by wholesale the followingmedicines (attach extra list if insufficient space provided here): Premises from where medicines are to be sold: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a bodycorporate):Date: Medicines Regulations 1984
Application to sell medicines by retail I hereby make application to sell by retail the following medicines(attach extra list if insufficient space provided here): Premises from where medicines are to be sold: I declare the above premises are more than 10 kilometres by roadfrom the nearest pharmacy.
The reasons for this application are: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a bodycorporate):Date: Application to hawk medicines I hereby make application for a licence to hawk medicines.
Premises where stock of medicines will be kept: Reprinted as at1 December 2011 Medicines Regulations 1984
Place where records of sale of medicines will be kept: Geographical area in which it is proposed to hawk medicines: Persons or classes of persons to whom it is proposed to hawkmedicines: Name and maximum quantity of medicines intended to be trans-ported when hawking: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a bodycorporate):Date: Schedule 2 form 1 heading: substituted, on 18 September 2004, by ofthe Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1 Part 1: amended, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1 Part 2: amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Medicines Regulations 1984
Application for licence to operate pharmacy made (by employee or agent) on behalf of Important information
Before filling out this application please note the following important
information:
•
this form may be used by an employee or agent who is makingan application on behalf of a company: you must make yourself familiar with the provisions of theand the Medicines Regulations 1984, inparticular those provisions relating to licensing and operatingpharmacies: the following must accompany this application:
•
the prescribed fee: a completed statutory declaration: it is an offence to make a false statutory declaration: the licensing authority may require you to supply additionalinformation at a later date (of the MedicinesAct 1981). If you do not supply that information within 30days of the request, this application will lapse.
Please complete the following: Applicant and company
I, [full name of employee or agent of company], [position in com-
pany], make this application for a licence to operate a pharmacy on
behalf of [name of company], which—
(a)
was incorporated in New Zealand on [date of incorporation];and has the following board members: [full names of all board members].
The address of the company is [address].
The following persons are nominated to be responsible persons forthe purposes of the licence under the :[full names, dates of birth, and positions held].
Reprinted as at1 December 2011 Medicines Regulations 1984
Street address and description of pharmacy
The street address of the pharmacy to which this application relates
is [street address].
The pharmacy will comprise the following part or parts of that street
address: [specify the part or parts of the street address that are to be
a pharmacy or attach a line drawing showing the part or parts].
Interests held in pharmacy
Note: Before filling out this part of the form please read of the Medicines Act 1981, which sets out the meaning of holding
an interest in a pharmacy.
The following person(s) or company (or companies) hold an interest
in the pharmacy (as defined in of the Medicines Act 1981)
to which this application relates: [name(s) of person(s) or company
(or companies), their address(es), and the particulars of the interest
held (or "none" if applicable)].
The following person(s) who hold an interest in the pharmacy to
which this applicaton relates is a (or are) practioner(s) (or registered
midwife (midwives)) (or designated prescriber(s)): [name of the in-
terest holder(s) and his or her relevant position (or "none" if applic-
able)].
Eligibility to hold licence
*The share capital of the company is more than 50% owned by [full
name of pharmacist] who is a pharmacist† (or [full names of pharma-
cists] who are pharmacists) and effective control of the company is
vested in the above-named pharmacist (or pharmacists).
Medicines Regulations 1984
†In this context, a pharmacist—
means a health practitioner who is, or is deemed to be, registered with thePharmacy Council established by as a practitioner of the profession of pharmacy; and includes an administrator of the estate of a deceased pharmacist, and anassignee within the meaning of the of the estate ofa pharmacist, until— the expiry of the period of 1 year after the date of the death ofthe deceased pharmacist, or the date on which the pharmacist wasadjudicated bankrupt; or subject to any conditions that the licensing authority proposes, theextended period or periods permitted by the licensing authority.
or
*The pharmacy to which this application relates is in a hospital
owned or operated by the company. [Specify details.]
or
*[Specify other ground in of the Medicines Act 1981
that makes the company eligible to hold a licence.]
*Delete if inapplicable.
Practices and procedures for pharmacists working in pharmacy
The following practices and procedures will be in place to ensure that
any pharmacist* who is employed or engaged in duties in the phar-
macy to which this application relates is not requested or required to
act in a way that is inconsistent with the applicable professional or
ethical standards of the pharmacy practice: [specify relevant prac-
tices and procedures].
*In this context, a pharmacist means a health practitioner who is, or is deemed to
be, registered with the Pharmacy Council established by as a practitioner of the profession of pharmacy.
Reprinted as at1 December 2011 Medicines Regulations 1984
Other pharmacies
The company operates the following pharmacy (or pharmacies):
[name(s) and address(es) of pharmacy (or pharmacies) (or "none"
if applicable)].
[Specify number, or "none" if applicable] of those pharmacies are (or
is) currently for sale.
*Mortgagee in possession
The company is a mortgagee in possession† of the pharmacy to which
this application relates.
*Delete if inapplicable.
†For the purposes of this application a mortgagee in possession has the same
meaning as in of the Property Law Act 2007.
Signature of applicant: Declaration
I, [full name of agent or employee of the company], of [place], [oc-
cupation], solemnly and sincerely declare that the statements made
in the above application are true and correct.
I make this solemn declaration conscientiously believing the same to
be true and by virtue of the
Declared at [place, date] before me: [Signature]Justice of the Peace(or other person authorised to take a statutory declaration) Schedule 2 form 1A: inserted, on 18 September 2004, by of the MedicinesAmendment Regulations 2004 (SR 2004/300).
Medicines Regulations 1984
Schedule 2 form 1A: amended, on 1 January 2008, of the Medicines(Property Law Act 2007) Amendment Regulations 2007 (SR 2007/382).
Reprinted as at1 December 2011 Medicines Regulations 1984
Application for licence to operate pharmacy made by person who is individual (or employee or agent of body corporate that is not company) Important information
Before filling out this application please note the following important
information:
•
this form may be used by—• an individual who is applying for a licence to operate apharmacy; or an employee or agent of a body corporate (other thana company) who is applying for a licence to operatea pharmacy on behalf of that body corporate (for ex-ample, an application made on behalf of a partnershipor friendly society): you must make yourself familiar with the provisions of theand the Medicines Regulations 1984, inparticular those provisions relating to licensing and operatingpharmacies: the following must accompany this application:
•
the prescribed fee: a completed statutory declaration: it is an offence to make a false statutory declaration: the licensing authority may require you to supply additionalinformation at a later date (of the MedicinesAct 1981). If you do not supply that information within 30days of the request, this application will lapse.
Please complete the following: Application (and body corporate)
I, [full name], of [address], being a resident of New Zealand, apply
for a licence to operate a pharmacy on—
*my own behalf.
*on behalf of the body corporate called [name of body corporate],
which—
(a)
is not a company, but is a [specify the type of body corporate];and Medicines Regulations 1984
was incorporated in New Zealand on [date]; and has the following board members (or trustees) (or partners):[full names of board members (or trustees) (or partners)].
*Delete if inapplicable.
My address (or The address of the body corporate) is [address].
*I was born on [date].
or
*I hold the office of [specify office held] within the above-named
body corporate. The following persons are nominated to be respon-
sible persons under [full names, dates of birth, and positions held].
*Delete if inapplicable.
Street address and description of pharmacy
The street address of the pharmacy to which this application relates
is [street address].
The pharmacy will comprise the following part or parts of that street
address: [specify the part or parts of the street address that are to be
a pharmacy or attach a line drawing showing the part or parts].
Interests held in pharmacy
Note: Before filling out this part of the form please read of the Medicines Act 1981, which sets out the meaning of holding
an interest in a pharmacy.
The following person(s) or company (or companies) hold an interest
in the pharmacy (as defined in of the Medicines Act 1981)
to which this application relates: [name(s) of person(s) or company
(or companies), their address(es), and the particulars of the interest
held (or "none" if applicable)].
The following person(s) who hold an interest in the pharmacy to
which this applicaton relates is a (or are) practioner(s) (or registered
midwife (midwives)) (or designated prescriber(s)): [name of the in-
terest holder(s) and his or her relevant position (or "none" if applic-
able)].
Reprinted as at1 December 2011 Medicines Regulations 1984
Eligibility to hold licence
*I am (or [Name of person in body corporate who has the majority
interest] is) a pharmacist for the purposes of this application because
I am (or he or she is) a health practitioner who is, or is deemed to
be, registered with the Pharmacy Council established by the as a practitioner of
the profession of pharmacy.
or
*I am (or The body corporate is) a pharmacist because [specify part
of the definition of pharmacist in of the Medicines
Act 1981] applies.
or
*The pharmacy I am (or The body corporate is) applying to operate
is in a hospital owned or operated by me (or the body corporate).
[Specify details.]
or
*I am (or The body corporate is) eligible to operate a pharmacy
because [specify other ground of the Medicines
Act 1981 that makes person or body corporate eligible to hold a li-
cence].
*Delete if inapplicable.
Practices and procedure for pharmacists working in pharmacy
The following practices and procedures will be in place to ensure that
any pharmacist* who is employed or engaged in duties in the phar-
macy to which this application relates is not requested or required
to act in a way that is inconsistent with the applicable professional
or ethical standards of the pharmacy practice: [specify practices and
procedures].
*In this context, a pharmacist means a health practitioner who is, or is deemed to
be, registered with the Pharmacy Council established by as a practitioner of the profession of pharmacy.
Medicines Regulations 1984
Other pharmacies
I operate (or have a majority interest in) (or The body corporate op-
erates) the following pharmacy (or pharmacies): [name(s) and ad-
dress(es) of the pharmacy (or pharmacies) (or "none" if applicable).]
[Specify number, or "none" if applicable] of those pharmacies are (or
is) currently for sale.
*Mortgagee in possession
I am (or The body corporate is) the mortgagee in possession† of the
pharmacy to which this application relates.
*Delete if inapplicable.
†For the purposes of this application a mortgagee in possession has the same
meaning as in of the Property Law Act 2007.
Signature of applicant: Declaration
I [full name of applicant], of [place], [occupation], solemnly and
sincerely declare that the statements made in the above application
are true and correct.
I make this solemn declaration conscientiously believing the same to
be true and by virtue of the Declared at [place, date] before me:
[Signature]Justice of the Peace(or other person authorised to take a statutory declaration) Schedule 2 form 1B: inserted, on 18 September 2004, by of the MedicinesAmendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1B: amended, on 1 August 2011, by of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Reprinted as at1 December 2011 Medicines Regulations 1984
Licence to manufacture medicines (Issued pursuant to the Licence No:Name of licensee:Address of licensee:Name of responsible persons: The *licensee or every responsible person named above is hereby au-thorised pursuant of the Medicines Act 1981 to manu-facture, pack, label, and sell by wholesale the following medicinesor classes of medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the following con-ditions:(1) The manufacture, packing, labelling, or sale of the medicinesshall be carried out in accordance with and the Medicines Regulations 1984.
[Further conditions imposed by the licensing authority]: This licence shall expire on [date].
Schedule 2 form 2: amended, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 2: amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Medicines Regulations 1984
Licence to hawk medicines (Issued pursuant to the Licence No:Name of licensee:Address of licensee:Names of responsible persons: The *licensee or every responsible person named above is herebyauthorised pursuant to of the Medicines Act 1981 to hawkthe following medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the followingconditions:(1) All sales shall be made in accordance with the and the Medicines Regulations 1984.
The stock of medicines held by the licensee or responsibleperson shall be stored only at the following place or places: The records of sale shall be kept at the following premises: Sales shall only be made within the following geographicalarea: Sales shall only be made to the following persons or classes ofpersons: [Further conditions imposed by the licensing authority]: This licence shall expire on [date].
Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 2 form 3: amended, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 3: amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Medicines Regulations 1984
Licence to sell medicines by wholesale (Issued pursuant to the Licence No:Name of licensee:Address of licensee:Name of responsible persons: Address of business premises: The *licensee or every responsible person named above is herebyauthorised pursuant of the Medicines Act 1981 to sellby wholesale the following medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the followingconditions:(1) The sale of the above medicines shall not take place other thanat the business premises set out above.
All sales shall be made in accordance with the and the Medicines Regulations 1984.
[Further conditions imposed by the licensing authority]: This licence shall expire on [date].
Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 2 form 4: amended, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 4: amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Medicines Regulations 1984
Licence to sell medicines by retail (Issued pursuant to the Licence No:Name of licensee:Address of licensee:Name of responsible persons: Address of business premises: The *licensee or every responsible person named above is herebyauthorised pursuant of the Medicines Act 1981 to sellby retail, and supply in circumstances corresponding to retail sale,the following medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the followingconditions:(1) The sale of the above medicines shall not take place other thanat the business premises set out above.
All sales shall be made in accordance with the and the Medicines Regulations 1984.
[Further conditions imposed by the licensing authority]: This licence shall expire on [date].
Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 2 form 5: amended, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 5: amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Medicines Regulations 1984
Licence to pack medicines (Issued pursuant to the Licence No:Name of licensee:Address of licensee:Names of responsible persons: Address of business premises: The *licensee or every responsible person named above is herebyauthorised pursuant of the Medicines Act 1981 to packor label for the purpose of sale, and sell by wholesale the followingmedicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the followingconditions:(1) The packing, labelling, or sale of the medicines shall be car-ried out in accordance with and theMedicines Regulations 1984.
[Further conditions imposed by the licensing authority]: This licence shall expire on [date].
Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 2 form 6: amended, on 18 September 2004, of theMedicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 6: amended, on 18 September 2004, by of theMedicines Amendment Regulations 2004 (SR 2004/300).
Medicines Regulations 1984
Licence to operate pharmacy Medicines Act 1981 Licence No:This licence to operate a pharmacy is granted to [full name of personor body corporate] of [address] and authorises—• the establishment of a pharmacy at [location] (or in the follow-ing part or parts of [location]: [specify relevant part or parts]);and the carrying on of pharmacy practice in that pharmacy.
*Names of responsible persons for body corporate: *Delete if inapplicable.
The pharmacy must be operated in accordance with the duties andobligations in .
This licence is subject to the following conditions:(a) the holder of this licence must not request or require anypharmacist who is employed or engaged in duties at theabove-named pharmacy to act in a way that is inconsistentwith the applicable professional or ethical standards of phar-macy practice: [specify any other conditions].
This licence expires on [date].
Schedule 2 form 7: added, on 18 September 2004, by of the MedicinesAmendment Regulations 2004 (SR 2004/300).
Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 3
Loose sheet data sheet requirements
Schedule 3: revoked, on 1 August 2011, of the MedicinesAmendment Regulations 2011 (SR 2011/245).
Schedule 4
Hawker's Medicines book
Name of medicine
dress of supplier
of medicine
or
Name and address
of person to whom
Medicines Regulations 1984
Schedule 5
Analyst's certificate under
I, [name], an analyst under the certify that on[date] there was submitted to me by [name and address of theofficer from whom the sample was received] an officer within themeaning of that Act, a sample of [name or description ofsample] for analysis in a [nature of the package in which thesample was enclosed, and how it was labelled, marked, andsealed] and that the same has been analysed and that theresult of the analysis is as follows [analysis and observa-tions]: Reprinted as at1 December 2011 Medicines Regulations 1984
Schedule 5A
Licence fees
Schedule 5A: inserted, on 21 August 2006, by of the Medicines(Fees) Amendment Regulations 2006 (SR 2006/188).
An application for a licence to manufacture medicines An application for a licence to pack An application for a licence to sell medicines by retail An application for a licence to sell medicines by wholesale An application for a licence to hawk An application for a combined licence to pack, and to sell by retail, medicines An application for a licence to operate Medicines Regulations 1984
Schedule 6
Restricted Drugs Regulations 1964 (SR 1964/64)
Restricted Drugs Regulations 1964, Amendment No 1
(SR 1966/84)
Restricted Drugs Regulations 1964, Amendment No 2
(SR 1967/250)
Restricted Drugs Regulations 1964, Amendment No 3
(SR 1969/95)
Restricted Drugs Regulations 1964, Amendment No 4
(SR 1969/193)
Restricted Drugs Regulations 1964, Amendment No 5
(SR 1971/55)
Restricted Drugs Regulations 1964, Amendment No 6
(SR 1972/53)
Restricted Drugs Regulations 1964, Amendment No 7
(SR 1972/163)
Restricted Drugs Regulations 1964, Amendment No 8
(SR 1973/111)
Restricted Drugs Regulations 1964, Amendment No 9
(SR 1974/93)
Restricted Drugs Regulations 1964, Amendment No 10
(SR 1974/133)
Restricted Drugs Regulations 1964, Amendment No 11
(SR 1975/25)
Reprinted as at1 December 2011 Medicines Regulations 1984
Restricted Drugs Regulations 1964, Amendment No 12
(SR 1977/130)
Restricted Drugs Regulations 1964, Amendment No 13
(SR 1978/52)
Restricted Drugs Regulations 1964, Amendment No 14
(SR 1979/37)
Restricted Drugs Regulations 1964, Amendment No 15
(SR 1979/273)
Restricted Drugs Regulations 1964, Amendment No 16
(SR 1981/120)
Restricted Drugs Regulations 1964, Amendment No 17
(SR 1982/32)
Restricted Drugs Regulations 1964, Amendment No 18
(SR 1982/248)
Restricted Drugs Regulations 1964, Amendment No 19
(SR 1983/132)
Restricted Drugs Regulations 1964, Amendment No 20
(SR 1983/289)
Restricted Drugs Regulations 1964, Amendment No 21
(SR 1984/78)
Restricted drugs licences Restricted Drug Licences Regulations 1961 (SR 1961/39)
Restricted Drug Licences Regulations 1961, Amendment No 1
(SR 1963/123)
Medicines Regulations 1984
Restricted Drug Licences Regulations 1961, Amendment No 2
(SR 1983/133)
Therapeutic drugs (permitted sales) Therapeutic Drugs (Permitted Sales) Regulations 1978
(SR 1978/34)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 1 (SR 1978/230)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 2 (SR 1979/168)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 3 (SR 1980/114)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 4 (SR 1980/264)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 5 (SR 1981/119)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 6 (SR 1981/324)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 7 (SR 1982/189)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 8 (SR 1983/20)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 9 (SR 1983/73)
Reprinted as at1 December 2011 Medicines Regulations 1984
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 10 (SR 1983/147)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 11 (SR 1983/205)
Therapeutic Drugs (Permitted Sales) Regulations 1978,
Amendment No 12 (SR 1984/41)
Clerk of the Executive Council.
Issued under the authority of Date of notification in Gazette: 7 June 1984.
Medicines Regulations 1984
Status of reprints How reprints are prepared Changes made under section 17C of the Acts and RegulationsPublication Act 1989 List of amendments incorporated in this reprint (most recentfirst) General
This is a reprint of the Medicines Regulations 1984. The
reprint incorporates all the amendments to the regulations as
at 1 December 2011, as specified in the list of amendments at
the end of these notes.
Relevant provisions of any amending enactments that contain
transitional, savings, or application provisions that cannot be
compiled in the reprint are also included, after the principal
enactment, in chronological order. For more information, see
.
Status of reprints
Under of the Acts and Regulations Publication
Act 1989, reprints are presumed to correctly state, as at the
date of the reprint, the law enacted by the principal enactment
and by the amendments to that enactment. This presumption
applies even though editorial changes authorised by of the Acts and Regulations Publication Act 1989 have
been made in the reprint.
This presumption may be rebutted by producing the official
volumes of statutes or statutory regulations in which the prin-
cipal enactment and its amendments are contained.
How reprints are prepared
A number of editorial conventions are followed in the prep-
aration of reprints. For example, the enacting words are not
included in Acts, and provisions that are repealed or revoked
Reprinted as at1 December 2011 Medicines Regulations 1984
are omitted. For a detailed list of the editorial conventions,see or Part 8 of the Tables of New Zealand Acts and Ordinancesand Statutory Regulations and Deemed Regulations in Force.
Changes made under section 17C of the Acts and
Regulations Publication Act 1989
of the Acts and Regulations Publication Act 1989
authorises the making of editorial changes in a reprint as set
out of that Act so that, to the extent
permitted, the format and style of the reprinted enactment is
consistent with current legislative drafting practice. Changes
that would alter the effect of the legislation are not permitted.
A new format of legislation was introduced on 1 January 2000.
Changes to legislative drafting style have also been made since
1997, and are ongoing. To the extent permitted of the Acts and Regulations Publication Act 1989, all legisla-
tion reprinted after 1 January 2000 is in the new format for
legislation and reflects current drafting practice at the time of
the reprint.
In outline, the editorial changes made in reprints under the au-
thority of of the Acts and Regulations Publication
Act 1989 are set out below, and they have been applied, where
relevant, in the preparation of this reprint:
•
omission of unnecessary referential words (such as "ofthis section" and "of this Act") typeface and type size (Times Roman, generally in 11.5point) layout of provisions, including:• position of section headings (eg, the number andheading now appear above the section) format of definitions (eg, the defined term now appearsin bold type, without quotation marks) format of dates (eg, a date formerly expressed as "the1st day of January 1999" is now expressed as "1 January1999") Medicines Regulations 1984
position of the date of assent (it now appears on the frontpage of each Act) punctuation (eg, colons are not used after definitions) Parts numbered with roman numerals are replaced witharabic numerals, and all cross-references are changedaccordingly case and appearance of letters and words, including:• format of headings (eg, headings where eachword formerly appeared with an initial cap-ital letter followed by small capital letters areamended so that the heading appears in bold,with only the first word (and any proper nouns)appearing with an initial capital letter) small capital letters in section and subsection ref-erences are now capital letters schedules are renumbered (eg, Schedule 1 replaces FirstSchedule), and all cross-references are changed accord-ingly running heads (the information that appears at the topof each page) format of two-column schedules of consequentialamendments, and schedules of repeals (eg, they arerearranged into alphabetical order, rather than chrono-logical).
List of amendments incorporated in this reprint
(most recent first)
District Courts Rules 2009 (SR 2009/257): Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR2005/266): Health Practitioners Competence Assurance Act 2003 (2003 No 48): Reprinted as at1 December 2011 Medicines Regulations 1984
Health and Disability Services (Safety) Act 2001 (2001 No Medicines Regulations 1984, Amendment No 6 (SR 1994/299) Health Amendment Act 1993 (1993 No Medicines Regulations 1984, Amendment No 5 (SR 1992/43) Medicines Regulations 1984, Amendment No 4 (SR 1991/134) Wellington, New Zealand: Published under the authority of the New Zealand Government—2011

Source: http://www.legislation.co.nz/regulation/public/1984/0143/16.0/096be8ed807d703d.pdf