Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1698847322081.pdf (New Zealand)
Version as at 16 June 2023 Medicines Regulations 1984 (SR 1984/143) David Beattie, Governor-General Order in Council At the Government House at Wellington this 5th day of June 1984 Present: His Excellency the Governor-General in Council Pursuant to section 105 of the Medicines Act 1981, and, in the case of Part 3 of the regulations, to section 62 of that Act, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations and bodies that appeared to the Minister to be representatives of persons likely to be substantially affected, and by and with the advice and consent of the Executive Coun‐ cil, hereby makes the following regulations.
Contents 1 2 2A Title and commencement Interpretation Transitional, savings, and related provisions Page 5 5 9 Note The Parliamentary Counsel Office has made editorial and format changes to this version using the powers under subpart 2 of Part 3 of the Legislation Act 2019.

Note 4 at the end of this version provides a list of the amendments included in it.

These regulations are administered by the Ministry of Health.
1 Medicines Regulations 1984 Part 1 Classification of medicines Version as at 16 June 2023 Classification of medicines Part 2 Standards Standards for medicines, related products, medical devices, cosmetics, and surgical dressings Standard for CBD products Pharmacist may dilute medicine in particular case Colouring substances [Revoked] Part 3 Advertisements Advertisements not to claim official approval Advertisements for medicines Advertisements for related products Advertisements for medical devices Advertisements intended for health professions Part 4 Labelling Medicines, related products, and medical devices not to be sold unless properly labelled Labelling of medicines Labelling of related products Exemptions from regulations 13 and 14 Principal display panel Form and manner of labelling Size of letters Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines Consumer information panel [Revoked] Labels on containers of medicines or related products containing vitamins Warning statements for medicines and related products Labels on containers of medicines sold by authorised prescribers or pharmacists Labels on containers of hair dyes Misleading statements Part 5 Manufacture, packing, storage, and handling Persons handling medicines, related products, and cosmetics Infected persons Persons in contact with infected persons 10 10 11 11 11 12 12 14 14 14 16 16 18 20 21 22 23 23 24 24 24 24 25 25 26 26 27 3 4 4A 26 27 28 2
26 27 28 2 Version as at 16 June 2023 Medicines Regulations 1984 29 30 31 32 33 34 35 36 37 Places of manufacture, storage, and sale Dwellinghouses prohibited for manufacture and packing Powers of Medical Officer of Health in respect of premises Storage of medicines, etc Construction and use of containers, etc Exposure to toxic substances prohibited Containers for medicines, related products, and cosmetics Storage to be separate Safety containers 38 Containers Part 6 Importation and transport Part 7 Prescriptions 39 39A
 40 40A 41 42 43 44 Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines Limit on period of supply of prescription medicines Prescriptions to comply with regulations Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed Form of prescription Dispensing of prescription medicines Director-General may waive certain requirements Prescriptions for prescription medicines not required in certain cases Administration of vaccines in approved immunisation programmes 44A 44AA Alternative authorisation of vaccinators 44AB Authorisation of COVID-19 vaccinators [Revoked] 44B Duty to supply information Part 7A Export of prescription medicines 44C No export of prescription medicines for retail sale without New Zealand prescription Part 7B Supply of restricted medicine and pharmacy-only medicine 44D Supply of restricted medicine and pharmacy-only medicine Part 8 Licences 45 45A 45B Application for licence to manufacture, hawk, sell, or pack medicine Application for licence to operate pharmacy Licences that relate to CBD products 27 28 28 29 29 30 30 31 31 32 33 33 34 34 35 36 38 39 41 42 43 43 44 45 45 46 47 3 Medicines Regulations 1984 Version as at 16 June 2023 46 47 48 48A 49 Form and conditions of licence Licence to manufacture medicines Licence to hawk certain medicines Licensing authority to be advised of change in particulars relating to operating pharmacy Surrender of licence Part 9
 Withdrawal of medicines, etc 50 Withdrawal of medicines, etc Part 10 Data sheets Interpretation Approval of data sheets for new medicines Approval of data sheets for changed medicines Particulars in data sheets [Revoked] Part 11 Records Sale of Medicines Registers Records of sales by retail or wholesale Record of hawker’s sales Record of supplies pursuant to prescriptions Records to be kept Part 12 Miscellaneous Substances that are not medicines or related products for purposes of Act Fluoridating agents
 and fluoridated water not medicines or related products Substances used to terminate pregnancy are medicines Non-oral products containing nicotine are medicines Medications used for assisted dying are medicines General sale medicines may be sold by vending machine Certificate of analyst Fees Waiver and refund of fees Fees inclusive of goods and services tax Medical devices Restriction on, and supervision of, compounding medicine Offences Appeals to District Court Transitional provision arising from enactment of Medicines Amendment Regulations 2011 [Revoked] 51 52 53 54 54A 55 56 57 58 58A 58B 58C 58D 58E 59 60 61 61A 61B 62 63 64 65 65A Version as at 16 June 2023 Medicines Regulations 1984 66 Revocations Schedule 1AA Transitional, savings, and related provisions Schedule 1 Prescription, restricted, and pharmacy-only medicines Schedule 2 Schedule 3 Loose sheet data sheet requirements [Revoked] Schedule 4 Hawker’s Medicines book Schedule 5 Analyst’s certificate under the Medicines Act 1981 Schedule 5A Licence fees Schedule 6 Regulations revoked Regulations r 2 60 61 62 153 176 176 177 178 179 1 (1) (2) 2 (1) Title and commencement These regulations may be cited as the Medicines Regulations 1984.
These regulations shall come into force on 1 August 1984.
Interpretation In these regulations, unless the context otherwise requires,— Act means the Medicines Act 1981 appropriate designation, in relation to a medicine, or an ingredient of a medi‐ cine, or a related product, or an active ingredient of a related product, has the following meaning in each of the cases specified: (a) where the medicine, related product, or ingredient is named or described in a monograph contained in the current edition of a specified publica‐ tion, the term means the name or one of the synonyms used in that speci‐ fied publication for that medicine, related product, or ingredient: (b) where the medicine, related product, or ingredient— (i) is not named or described in a monograph contained in the current edition of any specified publication but was named or described in a monograph contained in an earlier edition; and 5 r 2 Medicines Regulations 1984 Version as at 16 June 2023 (ii) is not sold under any name or description except the name or one of the synonyms used in that earlier edition for that medicine, related product, or ingredient,— the term means the name or one of the synonyms so used in that earlier edition followed immediately by a reference to that earlier edition: (c) where neither paragraph (a) nor paragraph (b) applies, the term means— (i) (ii) (iii) the international non-proprietary name of the medicine, related product, or ingredient; or if it has no international non-proprietary name, the name appear‐ ing in a list published in the United Kingdom on the recommenda‐ tion of the Medicines Commission pursuant to section 100 of the Medicines Act 1968 (UK); or if the medicine, related product, or ingredient has neither an inter‐ national non-proprietary name nor a name appearing in a list referred to in subparagraph (ii), its accepted scientific name or some other name descriptive of the true nature of the medicine, related product, or ingredient appropriate quantitative particulars, in relation to any active ingredients of a medicine or of a related product,— (a) (b) where
 the medicine or related product consists of or comprises tablets, capsules, or other separate portions, means the quantity (expressed by weight or volume) of each of the ingredients contained in each portion; or in any other case, means the percentage of each of those ingredients con‐ tained in the medicine or related product, or the quantity of each of those ingredients contained in a stated quantity of the medicine or related product approved immunisation programme means a vaccination programme— (a) pursuant to the National Immunisation Schedule administered by Phar‐ mac; or (b) approved by the Director-General or a Medical Officer of Health biochemical preparation includes— an antigen; and an antitoxin; and a toxin; and a blood fractionation preparation; and an insulin; and a preparation from a mammalian gland; and a serum; and (a) (b) (c) (d) (e) (f) (g) 6 Version as at 16 June 2023 (h) (i) Medicines Regulations 1984 r 2 a vaccine; and any other substance or preparation that is similar in nature 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 section 20 of the Act; and includes a provisional consent given under section 23 of the Act controlled drug has the same meaning as in the Misuse
 of Drugs Act 1975 described, in relation to any medicine, related product, or medical device, means represented or held out (whether in writing or otherwise) by the manu‐ facturer, seller, or supplier of the medicine, related product, or medical device dispensary technician means a person who holds a certificate issued by the Pharmaceutical Society of New Zealand before 18 September 2004 that— (a) (b) classifies the holder as a dispensary assistant; or records that the person has completed the requirements
 of the Pharmacy Technicians Certificate for external use, in relation to any medicine or related product, 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 sys‐ temic absorption 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 by section 99(2) of the Act Pharmac means the Pharmaceutical Management Agency continued by sec‐ tion 67 of the Pae Ora (Healthy Futures) Act 2022 Pharmacy Council means the Pharmacy Council established by section 114(5) of the Health Practitioners Competence Assurance Act 2003 pharmacy graduate means a person who is not a pharmacist, but who— (a) has 1 or more of the qualifications prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Competence Assurance Act 2003 for registration as a pharmacist; and (b) is actively taking steps towards registration as a pharmacist pharmacy student means a person who is undertaking, but has not yet com‐ pleted, the course and examinations leading to a qualification of a kind pre‐ scribed by the Pharmacy Council under section 12(1) of the Health Practition‐ ers Competence Assurance Act 2003 7 r 2
 Medicines Regulations 1984 Version as at 16 June 2023 pharmacy technician means any person who has a National Certificate in Pharmacy (Technician) pharmacy technician student means a person who is undertaking, but who has not yet completed, training and examinations leading to a National Certifi‐ cate in Pharmacy (Technician) poison bottle means a container that is made of glass, plastic, or other like material, and that either— (a) (b) has embossed on at least one-third of its outer surface narrow flutings,
 ribs, nettings, or points, or other similar surface impressions readily rec‐ ognisable by touch; or has clearly embossed on 2 opposite sides of the shoulder of the container the word “POISON” in capital letters, the height of the letters being not less than half the width of that shoulder principal display panel means the part of a label that is most likely to be dis‐ played, presented, shown, or examined under ordinary or customary conditions of display; and, if such likelihood 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 established by section 114(3) of the Health Practitioners Competence 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) (b) encloses a single tablet or other single item of a medicine that is a solid or a class of medicines that are solids (including a medicine or class of medicines in powder form); and is made of aluminium foil or laminated plastic, or such other material as may be approved by the Director-General in relation to the packaging of any solid medicine to which regulation 37 applies, either by notice in the Gazette or in writing addressed to a particular manufacturer, packer, importer, or seller of medicines; and (c) is reasonably resistant to attempts by young children to open it specified publication means a publication named in section 108(1) of the Act student means a pharmacy student or a pharmacy technician student.
(2) In these regulations, unless the context otherwise requires, all references to proportions in a medicine (whether as percentages, parts per million, or other‐ wise) shall be references to— (a) proportions by weight, where the medicine is a solid; or 8 Version as at 16 June 2023 Medicines Regulations 1984 r 2A (b) proportions by volume, where the medicine is a liquid at ambient tem‐ peratures.
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 paragraph (a): amended, on 29 November 2012, by regulation 4(1) of the Medicines Amendment Regulations 2012 (SR 2012/329).

Regulation 2(1) approved school: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) colouring substance: revoked, on 1 August 2011, by regulation 4(1) of the Medi‐ cines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) designated prescriber nurse: revoked, on 1 October 2005, by regulation 3 of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 2(1) Dispensary Assistant’s Certificate: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) dispensary technician: substituted, on 1 August 2011, by regulation 4(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) general sale medicine: inserted, on 1 August 2011, by regulation 4(3) of the Medi‐ cines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) Pharmac: inserted, on 29 November 2012, by regulation 4(2) of the Medicines Amendment Regulations 2012 (SR 2012/329).
Regulation 2(1) Pharmac: amended, on 1 July 2022, by section 104 of the Pae Ora (Healthy Futures) Act 2022 (2022 No 30).

Regulation 2(1) Pharmacy Council: inserted, on 1 August 2011, by regulation 4(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) pharmacy graduate: substituted, on 1 August 2011, by regulation 4(5) of the Medi‐ cines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy student: substituted, on 1 August 2011, by regulation 4(5) of the Medi‐ cines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) pharmacy technician: substituted, on 1 August 2011, by regulation 4(5) of the Med‐ icines Amendment Regulations 2011 (SR 2011/245).

Regulation 2(1) pharmacy technician student: inserted, on 19 December 2002, by regulation 3(3) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Regulation 2(1) registered midwife: substituted, on 18 September 2004, by section 175(3) of the Health Practitioners Competence Assurance Act 2003 (2003 No 48).

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 regulation 3(4) of the Medicines Amend‐ ment Regulations (No 2) 2002 (SR 2002/374).
2A Transitional, savings, and related provisions The transitional, savings, and related provisions set out in Schedule 1AA have effect according to their terms.

Regulation 2A: inserted, on 16 June 2023, by regulation 4 of the Medicines Amendment Regulations 2023 (SL 2023/130).
9 Part 1 r 3 Medicines Regulations 1984 Version as at 16 June 2023 Part 1 Classification of medicines 3 Classification of medicines (1) All medicines and classes of medicines specified in Part 1 of Schedule 1 are hereby declared to be prescription medicines.

(1A) [Revoked] (1B) [Revoked] (2) All medicines and classes of medicines specified in Part 2 of Schedule 1 are hereby declared to be restricted medicines.
(3) Subject to subclause (4), all medicines and classes of medicines specified in Part 3 of Schedule 1 are hereby declared to be pharmacy-only medicines.

(4) Nothing in subclause (3) shall apply to a remedy that is, and is described as, homoeopathic.

Regulation 3(1A): revoked, on 1 November 2005, by regulation 12(2)(a) of the Medicines (Designa‐ ted Prescriber: Nurse Practitioners) Regulations 2005 (SR 2005/266).
Regulation 3(1B): revoked, on 1 November 2005, by regulation 12(2)(a) of the Medicines (Designa‐ ted Prescriber: Nurse Practitioners) Regulations 2005 (SR 2005/266).
Part 2 Standards 4 Standards for medicines, related products, medical devices, cosmetics, and surgical dressings (1) Any medicine or related product, other than a medicine or related product for which a standard is otherwise prescribed in these regulations, shall, where it is described as conforming to a monograph in a specified publication, conform to the description and tests set out in that publication for that medicine or related product.
(2) (3) Every medicine, related product, or cosmetic used or represented as suitable for application into the eye shall conform to the tests for sterility set out in a speci‐ fied publication.

Every medicine, related product, or cosmetic that is a dusting powder for use on the skin of a baby, or on any inflamed, abraded, or broken skin, shall be free of pathogenic organisms.
(4) No medicine, related product, cosmetic, or dentifrice intended for sale shall contain or have attached to it or enclosed with it any extraneous thing that is harmful, dangerous, or offensive.

(5) A surgical dressing that is described as conforming to a monograph in a speci‐ fied publication shall conform to the description and tests set out in that publi‐ cation for that surgical dressing.
10 Version as at 16 June 2023 Medicines Regulations 1984 Part 2 r 6 (6) A medical device that is described as conforming to a particular description shall conform to that description.

4A Standard for CBD products (1) The minimum quality standard imposed by Part 1 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 applies to a CBD product as if it were both a cannabis-based ingredient and a medicinal cannabis product under those regulations.
(2) However, the minimum quality standard does not apply to a CBD product that is imported by— (3) (4) (5) (a) a medical practitioner whose purpose is to prescribe, supply, or adminis‐ ter it for the treatment of a particular patient under their care; or (b) a pharmacist for a prescription to which paragraph (a) applies.
Subclause (4) applies to a CBD product of a type that, at the commencement of this regulation, has been imported into New Zealand by the holder of a licence issued under the Medicines Act 1981.

The minimum quality standard does not apply to any of that product of the licence holder until 1 October 2021.

In this regulation, CBD product has the meaning given by section 2A of the Misuse of Drugs Act 1975.
Regulation 4A: inserted, on 1 April 2020, by regulation 84 of the Misuse of Drugs (Medicinal Canna‐ bis) Regulations 2019 (LI 2019/321).

Regulation 4A(4): amended, on 30 March 2021, by regulation 4 of the Medicines Amendment Regu‐ lations 2021 (LI 2021/44).

Regulation 4A(4): amended, on 30 September 2020, by regulation 4 of the Medicines Amendment Regulations 2020 (LI 2020/262).
5 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 com‐ patible diluent to the medicine if he is satisfied that— (a) (b) such dilution is necessary to adjust the dose to a quantity easily measura‐ ble by the patient or by any other person on behalf of the patient; and the addition of that diluent will not affect injuriously the composition of the medicine.
6 Colouring substances [Revoked] Regulation 6: revoked, on 1 August 2011, by regulation 5 of the Medicines Amendment Regulations 2011 (SR 2011/245).
11 Part 3 r 7 Medicines Regulations 1984 Version as at 16 June 2023 Part 3 Advertisements 7 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 advisory or technical committee established under section 8 of the Act, or any member of such a committee, or any officer in the service of the Government, has approved, or has refrained from disapproving, the advertisement or any of the claims or statements made in it.
8 (1) Advertisements for medicines Every advertisement for a prescription medicine must include— (a) (b) (c) (d) (e) (f) the words “Prescription medicine” or words of a similar meaning; and the name of each active ingredient; and the appropriate quantitative particulars of each active ingredient; and a statement of the purpose for which the medicine is intended to be used; and a statement that the medicine has risks and benefits; and a statement about how to find further information on the risks and bene‐ fits of the medicine.
(2) Every advertisement for a restricted medicine must include— (a) the following statements, or statements with a similar meaning: (i) (ii) “Available only from your pharmacist.”; and “If symptoms persist, see your doctor or health professional.”; and (iii) “Use only as directed.”; and the name of each active ingredient, or the following statement, or a state‐ ment with a similar meaning: “Always read the label.”; and a statement of the purpose for which the medicine is intended to be used; and any warning statement that may be required by guidelines issued from time to time by the Ministry of Health.
(b) (c) (d) (3) Every advertisement for a pharmacy-only medicine or a general sale medicine must include— (a) the following statements, or statements with a similar meaning: (i) (ii) “If symptoms persist, see your doctor or health professional.”; and “Use only as directed.”; and 12 Version as at 16 June 2023 (b) (c) (d) Medicines Regulations 1984 Part 3 r 8 the name of each active ingredient, or the following statement, or a state‐ ment with a similar meaning: “Always read the label.”; and a statement of the purpose for which the medicine is intended to be used; and any warning statement that may be required by guidelines issued from time to time by the Ministry of Health.
(4) Every advertisement for a medicine to be supplied by mail order, direct market‐ ing, or via the Internet must— (a) (b) include the name of each active ingredient; and include the appropriate quantitative particulars of each active ingredient; and (c) comply with the following, to the extent they are applicable: (i) (ii) subclause (1)(a), and (d) to (f): subclause (2)(a), (c), and (d): (iii) subclause (3)(a), (c), and (d).
(5) A statement required by this regulation must be— (a) (b) clearly printed; or clearly spoken.

(6) A statement that is required by this regulation may be both clearly printed and clearly spoken.
(7) This regulation does not apply to— (a) (b) an advertisement for a medicine that does not refer to a therapeutic pur‐ pose: an advertisement (not being an advertisement of the kind described in subclause (4)) that is— (i) (ii) located at the point of sale; and positioned immediately above, below, or next to the medicine to which it relates: (c) (d) labels: price lists.
(8) An advertisement for a prescription, restricted, pharmacy-only, or general sale medicine that is subsequently reclassified must be treated as compliant with this regulation if— (a) (b) the advertisement was compliant with every applicable requirement in this regulation immediately before the medicine was reclassified; and not more than 3 months have elapsed since the medicine was reclassi‐ fied.
13 Part 3 r 9 Medicines Regulations 1984 Version as at 16 June 2023 (9) In any proceedings for an offence against section 57 of the Act, it is for the defendant to prove that subclause (8) applies.

Regulation 8: substituted, on 1 August 2011, by regulation 6 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).

9 (1) (2) Advertisements for related products Every advertisement for a related product, other than a label or a price list, shall include a statement of the uses of the related product.
Every advertisement that refers to an active ingredient of a related product by name shall state the appropriate designation of the ingredient.
10 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) (b) (c) 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 in the use of the medical device: (d) a statement of any contraindications to the use of the medical device.
11 (1) Advertisements intended for health professions This regulation applies— (a) (b) to advertisements intended for members of the medical, dental, pharma‐ ceutical, and related professions; and in addition to the requirements in regulations 7, 9, and 10 (but not regu‐ lation 8).
(2) Every advertisement for a medicine must— (a) include— (i) (ii) (iii) (iv) (v) (vi) the classification of the medicine; and the name of each active ingredient; and the appropriate quantitative particulars of each active ingredient; and a statement of the purpose for which the medicine is intended to be used; and a statement of the appropriate precautions to be taken in the use of the medicine; and information on the effectiveness and limitations of the medicine; and (vii) a statement of any restriction imposed on distribution; and 14 Version as at 16 June 2023 Medicines Regulations 1984 Part 3 r 11 (viii) the dosage regime and mode of administration, or method of use, of the medicine; and (ix) (x) (xi) a statement of any contraindications to the use of the medicine; and information on the likely potentiating effects and interactions with other substances, medicines, or environmental influences; and a statement of the known or likely poisonous effects of, or adverse reactions to, the medicine; but (b) not include— (i) (ii) (iii) (iv) a statement (based on the citation of a report) relating to the effectiveness or safety of the medicine that omits relevant parts of the report, or quotes from the report in such a way that another meaning to that intended by the report is conveyed; or an unsubstantiated comparison with other medicines; or data, previously considered valid, but made obsolete or false by subsequent findings; or a statement of the use of the medicine, or the dosage of the medi‐ cine, that contravenes any condition of a consent given under sec‐ tion 20, 23, or 24 of the Act.
(3) Nothing in subclause (2)(a)(iii) or (vi) to (xi) applies to an advertisement that— (a) is intended to provide a practitioner with details of— (i) (ii) a major therapeutic indication of a medicine; or the listing of a medicine in the pharmaceutical schedule (within the meaning of section 4 of the Pae Ora (Healthy Futures) Act 2022); or (iii) a new or changed strength of a medicine; and (b) does not enable the practitioner to reach a prescribing decision.
(4) Every advertisement for a related product or medical device must include— (a) (b) (c) a statement of any restriction imposed on distribution; and the dosage regime and mode of administration, or method of use, of the related product or medical device; and information on the effectiveness and limitations of the related product or medical device.

Regulation 11: substituted, on 1 August 2011, by regulation 7 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
Regulation 11(3)(a)(ii): amended, on 1 July 2022, by section 104 of the Pae Ora (Healthy Futures) Act 2022 (2022 No 30).
15 Part 4 r 12 Medicines Regulations 1984 Version as at 16 June 2023 Part 4 Labelling 12 Medicines, related products, and medical devices not to be sold unless properly labelled (1) No person shall sell any medicine or related product in a container if the con‐ tainer— (a) (b) (c) does not bear a label containing all the particulars required by these regulations to be on a label relating to such a container; or bears a label containing anything that is prohibited by these regulations from appearing on a label relating to such a container; or bears a label containing any particulars that are not in the position, man‐ ner, and style required by these regulations in respect of a label relating to such a container.
(2) No person shall sell a package containing a single container of any medicine or related product unless that package is labelled in a manner similar to that in which the container is labelled.

(3) No person shall sell any medicine in a poison bottle bearing any label that obscures any flutings, ribs, nettings, points, embossed words, or similar mark‐ ings on the bottle.
(4) No person shall sell any medical device that does not bear the name of the manufacturer of the medical device or the name of the manufacturer’s distribu‐ tor in New Zealand.

(5) Notwithstanding anything in the foregoing provisions of this regulation, the Director-General may, by notice in writing to the manufacturer or importer of any medicine, exempt from the labelling requirements of these regulations the sale of that medicine in a container of a specified type.
Labelling of medicines Every container of a medicine must, unless otherwise provided by these regula‐ tions, bear a label containing the following information: (a) (b) (c) (d) (e) the trade name of the medicine or, if there is no trade name, the appropri‐ ate designation of the medicine: the name of each active ingredient: the appropriate quantitative particulars of each active ingredient: a description of the medicine, including dose form, or presentation, that indicates the true nature of the medicine: a statement of the net weight or volume or number of the contents of the container, as the case may require: (f) in the case of a prescription medicine,— 13 (1) 16 Version as at 16 June 2023 Medicines Regulations 1984 Part 4 r 13 (i) (ii) the words “PRESCRIPTION MEDICINE” or words of a similar meaning; or the words “PRESCRIPTION-ONLY MEDICINE” or words of a similar meaning; or (iii) the acronym “POM”: (g) in the case of a restricted medicine,— (i) (ii) the words “RESTRICTED MEDICINE”; or the words “PHARMACIST-ONLY MEDICINE”: (h) in the case of a pharmacy-only medicine,— (i) (ii) the words “PHARMACY-ONLY MEDICINE” or words of a simi‐ lar meaning; or the words “PHARMACY MEDICINE” or words of a similar meaning: any warning statement required by these regulations for the medicine: in the case of a medicine other than a prescription medicine, a statement of the purpose for which the medicine is intended to be used: (i) (j) (k) in the case of a medicine sold, or intended for sale, for external use,— (i) (ii) a
 statement of directions for use and frequency of use; and the words “Caution: not to be taken”, or “For external use only”, or words of a similar meaning: (l) in the case of a medicine sold, or intended for sale, for internal use,— (i) (ii) the dose recommended; and the frequency of that dose: (m) (n) the words “Batch Number” or “Lot Number”, or the word “Batch” or “Lot”, or the letter “B” (either alone or inside a circle) followed by the batch or lot number of the medicine: the words “Use by” or “Use before”, or
 words of a similar meaning, fol‐ lowed by the expiry date (being in no case later than 5 years after the date of manufacture of the medicine) appropriate to the stability of the medicine: (o) where appropriate, a statement of the recommended storage conditions: (p) the name and address of— (i) (ii) the manufacturer or seller of the medicine; or the owner of the rights of manufacture; or (iii) the agent of any person who comes within subparagraph (i) or (ii).
(2) For the purposes of subclause (1)(p),— (a) an address at a post office is not sufficient: 17 Part 4 r 14 Medicines Regulations 1984 Version as at 16 June 2023 (b) (c) the name and address of a person not ordinarily resident in New Zealand are not sufficient unless the medicine is wholly manufactured and packed outside New Zealand: in the case of a body corporate registered in New Zealand, the name of the town in which the body corporate has its registered office is suffi‐ cient.
(3) In the case of a medicine intended for administration only in accordance with the directions of a practitioner, it is sufficient compliance with subclause (1)(l) to indicate the dose by a range if the container is accompanied by a more spe‐ cific statement relating to each usage.
(4) In the case of a prescription medicine, compliance with the requirements of subclause (1)(k) or (l) is required only at the time at which that medicine— (a) (b) (c) is sold by retail; or is supplied in circumstances corresponding to retail sale; or is supplied by way of gift or sample for the purpose of promoting a sale.
(5) (6) (7) Subclause (1)(l) does not apply in the case of a medicine intended to be admin‐ istered by or under the supervision of a practitioner, in circumstances where the dosage is to be dependent on concurrent skilled observation.

Every container of a medicine that is prepared for injection into the human body and that contains an antiseptic or preservative must be labelled with a statement of the nature and amount of the antiseptic or preservative.
Every container of a medicine that is a biochemical preparation must, in add‐ ition to the other requirements in this regulation, bear a label containing the fol‐ lowing: (a) (b) a statement of the potency of the preparation; and a statement of the nature and amount of every antiseptic or preservative (if any) used in the medicine.
(8) Where it is impractical to put all of the information required by this regulation on a label because the container is too small, it is sufficient compliance with this regulation to print the information required by subclause (1)(i), (j), and (o) on a separate information sheet, in the same manner as that information would be required by these regulations to be printed on a label, and to supply that sheet to the customer with the medicine.

(9) This regulation is subject to regulations 15 and 23.
Regulation 13: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
Labelling of related products Every container of a related product must, unless otherwise provided by these regulations, bear a label containing the following information: 14 (1) 18 Version as at 16 June 2023 Medicines Regulations 1984 Part 4 r 14 (a) (b) (c) (d) (e) (f) (g) the trade name of the related product or, if there is no trade name, the appropriate designation of the related product: the name of each active ingredient: the appropriate quantitative particulars of each active ingredient: a description of the related product that indicates the true nature of the related product: a statement of the net weight or volume or number of the contents of the container, as the case may require: any warning statement required by these regulations for the related prod‐ uct: in the case of a related product sold, or intended for sale, for external use,— (i) (ii) a statement of directions for use and frequency of use; and the words “Caution: not to be taken”, or “For external use only”, or words of a similar meaning: (h) in the case of a related product sold, or intended for sale, for internal use,— (i) (ii) the dose recommended; and the frequency of that dose: (i) (j) (k) the words “Batch Number” or “Lot Number”, or the word “Batch” or “Lot”, or the letter “B” (either alone or inside a circle) followed by the batch or lot number of the related product: where appropriate, an expiry date: the name and address of— (i) (ii) the manufacturer or seller of the related product; or the owner of the rights of manufacture; or (iii) the agent of any person who comes within subparagraph (i) or (ii).
(2) For the purposes of subclause (1)(k),— (a) (b) (c) an address at a post office is not sufficient: the name and address of a person not ordinarily resident in New Zealand are not sufficient unless the related product is wholly manufactured and packed outside New Zealand: in the case of a body corporate registered in New Zealand, the name of the town in which the body corporate has its registered office is suffi‐ cient.
Regulation 14: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
19 Part 4 r 15 Medicines Regulations 1984 Version as at 16 June 2023 15 Exemptions from regulations 13 and 14 (1) Nothing in regulation 13 (except subclause (1)(a), (b), (c), (m), and (n)) and nothing in regulation 14 (except subclause (1)(a), (b), (c), (i), and (j)) applies to— (a) a container that— (i) (ii) (iii) (iv) contains a single dose of a medicine or related product; and is made of sheet material; and is not attached to another container; and is contained in a package that complies with regulation 13 or 14 (as the case requires); and (v) is not intended for sale other than in that package: (b) a container that— (i) (ii) (iii) (iv) contains a single dose of a medicine or related product; 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 regulation 13 or 14 (as the case requires); and (v) is not intended for sale other than in that package: (c) a container (other than an aerosol container) that— (i) (ii) contains a medicine or related product that is a gas; and is of a kind commonly used for storing or transporting gases in compressed, liquefied, or dissolved form; and (iii) has a capacity not exceeding 250 litres water capacity: (d) a container of a remedy that is, or is described as, homeopathic.
(2) Nothing in regulation 13 or 14 applies to a strip of containers that— (a) (b) is made of sheet material; and bears the information required by— (i) (ii) regulation 13(1)(m) and (n) or regulation 14(1)(i) and (j) (as the case requires) at least once on the strip; and regulation 13(1)(a), (b), and (c) or regulation 14(1)(a), (b), and (c) (as the case requires)— (A) at least once in relation to every 2 containers, if the contain‐ ers are easily detached from the strip; and (B) at least once on the strip in any other case; and (c) is contained in a package that complies with regulation 13 or 14 (as the case requires); and (d) is not intended for sale other than in that package.
20 Version as at 16 June 2023 Medicines Regulations 1984 Part 4 r 16 (3) In this regulation, strip of containers means a series of containers that each contain a single dose of a medicine or related product and that together form a strip.
(4) Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a manufac‐ turer or wholesaler, for the period of 3 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy- only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in-trade in New Zealand of the manufacturer or wholesaler.
(5) Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a retailer, for the period of 6 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in- trade in New Zealand of the retailer.
(6) (7) 16 (1) (2) (3) For the purposes of subclauses (4) and (5), any goods purchased before the date on which a substance becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) for importation into New Zea‐ land are deemed to be part of the purchaser’s stock-in-trade in New Zealand.
In any proceedings for an offence against section 44 of the Act in respect of any container that does not comply with regulation 13(1)(f), (g), or (h), the onus is on the defendant to prove that the relevant paragraph does not apply by virtue of subclause (4) or (5) of this regulation.

Regulation 15: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
Principal display panel The principal display panel of the label of a medicine must contain— (a) (b) the information required by regulation 13(1)(a), (d), and (e); and the information required by regulation 13(1)(b) and (c), but only if the medicine contains 3 or fewer active ingredients.

Subclause (1) is subject to regulation 23.


The principal display panel of the label of a related product must contain— (a) (b) the information required by regulation 14(1)(a), (d), and (e); and the information required by regulation 14(1)(b) and (c), but only if the related product contains 3 or fewer active ingredients.
(4) Nothing in subclause (1) or (3) prevents the inclusion in the principal display panel of any other matters required by these regulations to appear on a label of any medicine or related product.

(5) Subclause (4) is subject to regulation 19.

21 Part 4 r 17 Medicines Regulations 1984 Version as at 16 June 2023 Regulation 16: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
Form and manner of labelling Subject to subclause (4), every label that is required by these regulations to be borne on a container shall— (a) (b) (c) (d) (e) (f) (g) be conspicuously written in English and, for each statement separately required, be in a colour or colours contrasting strongly with the state‐ ment’s background; and be legibly and durably marked either on the material of the container or on material firmly and securely attached to the container; and be of such nature and material that it will not fade to the extent of becoming illegible, or become detached, by the influence of— (i) (ii) (iii) (iv) (v) light; or 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 not readily be defaced in the course of normal handling and use; 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.
[Revoked] The lettering of the words required by these regulations shall be clear, distinct, and legible, with no decoration, embellishment, or distortion that could inter‐ fere with the legibility of the words.

Every label that is required by these regulations to appear on a container shall, if the medicine or related product is sold otherwise than in a container, appear on the medicine or related product.
It shall be sufficient compliance with subclause (1) if the particulars required by paragraphs (d) and (e) of regulation 13(1) are embossed conspicuously on the container of the medicine.

Regulation 17(1)(a): amended, on 30 November 2000, by regulation 7(1) of the Medicines Amend‐ ment Regulations 2000 (SR 2000/220).

Regulation 17(1)(g): revoked, on 30 November 2000, by regulation 7(2) of the Medicines Amend‐ ment Regulations 2000 (SR 2000/220).
17 (1) (2) (3) (4) 22 Version as at 16 June 2023 18 Size of letters Medicines Regulations 1984 Part 4 r 19 (1) A minimum size of lettering used on labels that is prescribed by these regula‐ tions refers to the height of capital letters, or lower case letters with an ascender or descender, in the typeface used.
(2) (3) (4) (5) [Revoked] [Revoked] [Revoked] Subject to subclause (6) and except as otherwise expressly permitted by any of the provisions of these regulations, the lettering of words required by these regulations to appear on labels shall be not less than 1.5 millimetres in height.
(6) Where words are required by these regulations to appear on labels in letters of a specified size, and the container to be labelled 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 largest size practicable in the circumstances and are in any event no smaller than 0.75 millimetres.

(7) [Revoked] Regulation 18(1): substituted, on 30 November 2000, by regulation 8(1) of the Medicines Amend‐ ment Regulations 2000 (SR 2000/220).
Regulation 18(2): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).

Regulation 18(3): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).

Regulation 18(4): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).

Regulation 18(7): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
19 Labelling of prescription medicines, restricted medicines, and pharmacy- only medicines Where a label on a container is required by these regulations to bear— (a) (b) (c) (d) (e) (f) (g) the words “PRESCRIPTION MEDICINE” or words of a similar mean‐ ing; or the words “PRESCRIPTION ONLY MEDICINE” or words 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” or words of a similar meaning; or the words “PHARMACY MEDICINE” or words of a similar mean‐ ing,— 23 Part 4 r 20 Medicines Regulations 1984 Version as at 16 June 2023 the words or acronym, as the case may require, shall be placed prominently and legibly on the label.
Regulation 19: substituted, on 1 January 1995, by regulation 5 of the Medicines Regulations 1984, Amendment No 6 (SR 1994/299).

Regulation 19: amended, on 1 August 2011, by regulation 9 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).

20 Consumer information panel [Revoked] Regulation 20: revoked, on 1 August 2011, by regulation 10 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
21 Labels on containers of medicines or related products containing vitamins The quantitative declaration of every vitamin in any medicine or related prod‐ uct shall be expressed in milligrams or micrograms.

22 Warning statements for medicines and related products (1) Every container of a medicine or related product must include on its label any warning statement that may be required by guidelines issued from time to time by the Ministry of Health.
(2) A warning statement is additional to any other statement or information that is required by these regulations to be shown on a label.

(3) Subclause (1) is subject to regulation 23.

Regulation 22: substituted, on 1 August 2011, by regulation 11 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
23 Labels on containers of medicines sold by authorised prescribers or pharmacists It shall not be necessary to comply with the requirements of regulation 13 or regulation 16(1) or regulation 22 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 reference to the needs of a particular patient or (as the case may be) a particular customer, if the label contains the following: (a) (b) (c) (d) (e) the name of, or a description of the nature of, the contents; 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 and frequency of dose; and in the case of a medicine for external use, a statement of the directions for use and frequency of use, and one or other of the following state‐ ments, or words of similar meaning: “Caution: Not To Be Taken”, or “For External Use Only”; and 24 Version as at 16 June 2023 Medicines Regulations 1984 Part 4 r 25 (f) a unique identifying number or code for the prescription or record of supply; and (g) the date on which the medicine was packed, sold, or supplied.
Regulation 23 heading: substituted, on 11 October 2001, by regulation 7(1) of the Medicines Amend‐ ment Regulations 2001 (SR 2001/232).

Regulation 23 heading: amended, on 1 October 2005, by regulation 5(1) of the Medicines Amend‐ ment Regulations 2005 (SR 2005/255).

Regulation 23: amended, on 1 August 2011, by regulation 12(1) of the Medicines Amendment Regu‐ lations 2011 (SR 2011/245).
Regulation 23: amended, on 1 October 2005, by regulation 5(2) of the Medicines Amendment Regu‐ lations 2005 (SR 2005/255).

Regulation 23(a): substituted, on 1 August 2011, by regulation 12(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 23(e): amended, on 1 August 2011, by regulation 12(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 23(f): added, on 1 August 2011, by regulation 12(3) of the Medicines Amendment Regu‐ lations 2011 (SR 2011/245).
Regulation 23(g): added, on 1 August 2011, by regulation 12(3) of the Medicines Amendment Regu‐ lations 2011 (SR 2011/245).
24 (1) Labels on containers of hair dyes This regulation applies to labels on containers of related products and cosmet‐ ics that are intended for dyeing hair and consist of or contain— (a) (b) (c) (d) phenylenediamine, or its salts; or toluenediamine, or its salts; or other aromatic amines intended for dyeing hair, or their salts; or any derivative of any substance to which paragraph (a) or paragraph (b) or paragraph (c) applies.
(2) Every label to which this regulation applies shall include the following: (a) (b) (c) (d) the name or description of the dye substance: the name and address of the manufacturer or (as the case may be) the packer or seller of the related product or cosmetic: directions for the use of the related product or cosmetic: one or other of the following statements, or words of similar meaning: “Not To Be Taken”, or “For External Use Only”: (e) the following statement, or words of similar meaning: “May cause serious inflammation of the skin.
Do not use on eyelashes”.
25 Misleading statements (1) No written, pictorial, or other descriptive matter appearing on or attached to or supplied or displayed with any medicine or medical device shall include any comment on, reference to, or explanation of any statement or label required by 25 Part 5 r 26 Medicines Regulations 1984 Version as at 16 June 2023 these regulations to be borne on any medicine or medical device if that com‐ ment, reference, or explanation either directly or by implication contradicts, qualifies, or modifies that statement or the contents of that label.
(2) No written, pictorial, or other descriptive matter supplied or displayed with any medicine or medical device shall include any false or misleading statement, word, brand, picture, or mark purporting to indicate the nature, suitability, quantity, quality, strength, purity, composition, weight, origin, age, effects, or proportion of the medicine or medical device or any ingredients of the medi‐ cine or components of the medical device.
Part 5 Manufacture, packing, storage, and handling 26 (1) Persons handling medicines, related products, and cosmetics Every person who— (a) (b) is engaged or employed in the manufacture, packing, labelling, storage, or supply of any medicine, related product, or cosmetic for sale; and in the course of his engagement or employment in that activity comes into direct contact with— (i) (ii) any medicine, related product, or cosmetic; or the interior part of any container containing any medicine, related product, or cosmetic; or (iii) a wrapper for any medicine, related product, or cosmetic— shall, at all times while so engaged or employed, maintain his clothing and his person in a state of cleanliness.
(2) No person who is engaged or employed in the sale of any medicine, related product, or cosmetic, or in the manufacture, packing, labelling, storage, or sup‐ ply of any medicine, related product, or cosmetic for sale, shall do any act or make any default or omission whereby that medicine, related product, or cos‐ metic becomes or is liable to become contaminated, polluted, or tainted.
27 Infected persons No person who is suffering from a communicable disease (within the meaning of the Health Act 1956), or is a carrier (within the meaning of that Act), or is suffering from a condition 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— any medicine, related product, or cosmetic; or any material or article used or likely to be used as a wrapper or container for any medicine, related product, or cosmetic.
(a) (b) 26 Version as at 16 June 2023 Medicines Regulations 1984 Part 5 r 29 28 (1) Persons in contact with infected persons The Medical Officer of Health may, by notice in writing served on a person who has been in recent contact with any person to whom regulation 27 applies, prohibit the person so served from engaging or being employed in the sale of any medicine, related product, or cosmetic, or the manufacture, packing, label‐ ling, storage, or supply of any medicine, related product, or cosmetic for sale.
(2) Where, in the opinion of the Medical Officer of Health, there is no longer any risk of any medicine, related product, or cosmetic becoming infected by a per‐ son on whom any such notice has been served, the Medical Officer of Health shall revoke the notice, and shall notify the person in writing of the revocation.
(3) No person shall— (a) (b) engage or undertake employment in any activity in contravention of a notice served on him under this regulation; or knowingly employ any other person in contravention of a notice served on that other person under this regulation.
29 Places of manufacture, storage, and sale No person shall use any place or permit any place to be used for or in connec‐ tion with the sale of any medicine, related product, or cosmetic, or the manu‐ facture, storage, or packing of any medicine, related product, or cosmetic for sale, unless the place complies with the following requirements: (a) (b) (c) (d) (e) (f) the place shall be kept adequately lighted by daylight or artificial light, as the circumstances require, at all times when any work is being carried out there: the place shall be kept appropriately ventilated at all times while any medicine, related product, or cosmetic, or any container or material for the packing of any medicine, related product, or cosmetic, is present there: if a waste liquid is produced there, the place shall be provided with a means of drainage that is sufficient for the 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 and free from foul odours and free from dust and creatures likely to contaminate the medi‐ cine, related product, or cosmetic: the walls, floors, ceilings, and roofs shall be properly constructed and kept in good repair, and shall be easy to clean: the place shall not be used for any purpose (other than the sale of any medicine, related product, or cosmetic, or the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale) that might affect the quality of the medicine, related
 product, or cosmetic: 27 Part 5 r 30 Medicines Regulations 1984 Version as at 16 June 2023 (g) (h) (i) the place shall be provided with sinks and other sanitary fittings reason‐ ably necessary for cleansing appliances used there, and all such sinks and other sanitary fittings shall be maintained in good, clean working order and condition: the place shall be provided with an adequate supply of hot and cold water, and soap or other detergent: the place shall be provided adequately with wash basins and toilets for the use of persons engaged or employed in or about the premises, and all such wash basins and toilets shall be maintained in good, clean working order and condition, and shall be provided with an adequate supply of hot and cold water, soap or other detergent, nail brushes, and towels or other drying equipment.
30 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.
31 (1) (2) Powers of Medical Officer of Health in respect of premises This regulation shall apply to premises that are, in the opinion of the Medical Officer of Health, by reason of their construction or disrepair, or by reason of the use or character of any neighbouring premises, in such a condition that any medicine, related product, or cosmetic in the first premises may be exposed to contamination or taint, or may deteriorate or become dirty.
Subject to subclause (6), the Medical Officer of Health may serve a notice in writing on any owner or occupier of any premises to which this regulation applies, prohibiting the use of the premises for or in connection with the manu‐ facture, storage, or packing of any medicine, related product, or cosmetic for sale.

(3) Every such notice shall— (a) (b) (c) specify the premises to which it relates: state the reason for the prohibition: specify a date on which the prohibition is to come into force.
(4) Subject to subclause (6), where in the opinion of the Medical Officer of Health the reason for which any such notice was served has ceased to exist, he shall revoke the notice, and shall notify in writing the owner or occupier of the premises concerned, and every other person on whom a copy of the notice has been served, of the revocation.
(5) While any such notice remains in force,— 28 Version as at 16 June 2023 (a) Medicines Regulations 1984 Part 5 r 33 no person on whom it has been served shall use or permit the use of the premises specified in the notice for or in connection with the manufac‐ ture, storage, or packing of any medicine, related product, or cosmetic for sale; and (b) no person on whom a copy of the notice has been served or who knows the contents of the notice shall use those premises for any such purpose.
(6) No notice shall be served by a Medical Officer of Health pursuant to subclause (2) or subclause (4) unless approval to serve the notice has first been obtained from the Director-General.
32 (1) (2) Storage of medicines, etc Every person in possession or control of any medicine, related product, or cos‐ metic for sale, or of any container or appliance used for or in connection with the sale of any medicine, related product, or cosmetic, or the manufacture, stor‐ age, or packing of any medicine, related product, or cosmetic for sale, shall at all times— (a) (b) keep the medicine, related product, cosmetic, container, or appliance clean and free from contamination by moisture, foul odours, or dust; and protect the medicine, related product, cosmetic, container, or appliance from access by creatures likely to contaminate it.
Every person in possession of any medicine, related product, or cosmetic for sale shall at all times store and keep it packed in such manner as to minimise its deterioration, and shall comply with all requirements for storage stated on the label or contained in a specified publication in respect of that medicine, related product, or cosmetic.
33 Construction and use of containers, etc (1) No person shall use, or permit to be used, any container, appliance, 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 vehicle is constructed of such material and in such manner as to allow for easy cleaning, and is kept clean.
(2) No person shall use, or permit to be used, in the supply of any medicine, rela‐ ted product, or cosmetic for sale any container, appliance, or vehicle that is also used for the carriage of any matter that endangers or could endanger the clean‐ liness or freedom from contamination of the medicine, related product, or cos‐ metic.
(3) No person shall use, or permit to be used, for the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale, any container that has been used for any purpose that may contaminate or taint the medicine, related product, or cosmetic, unless the container has been thoroughly cleaned.
29 Part 5 r 34 Medicines Regulations 1984 Version as at 16 June 2023 34 Exposure to toxic substances prohibited Except as otherwise provided in these regulations, no person 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 contamination by that sub‐ stance at any time.
35 Containers for medicines, related products, and cosmetics (1) A person must not pack, store, or sell a prescription medicine, restricted medi‐ cine, or pharmacy-only medicine in a container made of paper; but nothing in this subclause prevents the person from packing, storing, or selling the medi‐ cine in a container made of cardboard.
(2) [Revoked] (3) No person shall use, or permit to be used, in the storage, packing, or supply of any medicine, related product, or cosmetic for sale, a container that yields, or could yield, to its contents a toxic, injurious, or tainting substance.

(4) (5) (6) (7) Every container used in the packing of a medicine and made of glass or plastic shall comply with the tests for that type of container (if any) specified in the United States Pharmacopeia.
Every container used in the packing of a medicine and made of metal shall be impermeable to moisture.

Every container used in the packing of a medicine and made of metal or plastic shall be made of a material that will not adversely 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 millilitres and not more than 2.5 litres any medicine, related product, or cosmetic that— (a) (b) (c) is in liquid form; and is intended for external use; and has poisonous properties,— unless the container is a poison bottle.
(8) It shall not be necessary to pack in a poison bottle any medicine, related prod‐ uct, or cosmetic to which subclause (7) applies if that medicine, related prod‐ uct, or cosmetic is— (a) (b) supplied to or held for use in educational establishments, or in scientific or industrial laboratories; or supplied to or held by analysts, pharmacists, authorised prescribers, or veterinary surgeons; or 30 Version as at 16 June 2023 Medicines Regulations 1984 Part 5 r 37 (c) supplied to or held by persons engaged as suppliers to any of the estab‐ lishments, laboratories, or classes of persons mentioned in paragraphs (a) and (b); or (d) a hair dye to which regulation 24 applies.
(9) No person shall have in his possession or charge (whether for the purposes of sale or otherwise) in an open container, any medicine, related product, or cos‐ metic that has poisonous properties, except while the container is being filled or the medicine, related product, or cosmetic in the container is being used.
(10) No person in possession or charge of any medicine, related product, or cos‐ metic shall keep it, whether temporarily or permanently, in any bottle, jar, can, tinplate container, culinary utensil, or other container of a type that— (a) (b) bears any brand, mark, statement, or picture that indicates the presence in the container of any food, drink, or condiment; or is of a distinctive type in which any food, drink, or condiment, has been commonly or is being currently sold, whether or not the container bears any brand, mark, statement, or picture.
Regulation 35(1): substituted, on 24 July 2006, by regulation 6 of the Medicines Amendment Regula‐ tions 2006 (SR 2006/158).

Regulation 35(2): revoked, on 24 July 2006, by regulation 6 of the Medicines Amendment Regula‐ tions 2006 (SR 2006/158).

Regulation 35(8)(b): amended, on 1 October 2005, by regulation 6 of the Medicines Amendment Regulations 2005 (SR 2005/255).
36 Storage to be separate No person shall store or keep for ready use any medicine, related 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.
37 Safety containers (1) No person shall sell any tablet, or other single item in solid form that is inten‐ ded to be taken orally, being or comprising a medicine or belonging to a class of medicines to which this regulation applies, unless the tablet or item is enclosed in a safety container.
(2) Subclause (1) shall not apply— (a) where an authorised prescriber directs, either on the prescription or otherwise,— (i) (ii) that a medicine is not to be sold enclosed in a safety container; or that he or she does not wish the name of the medicine to appear on the label; or 31 Part 6 r 38 Medicines Regulations 1984 Version as at 16 June 2023 (b) where a pharmacist is of the opinion that, because of the age or infirmity of a particular person, a medicine to be used by that person should not be enclosed in a safety container; or (c) in the case of capsules, pills, powder, or other solid dose forms, prepared in a pharmacy with reference to the particular needs of a patient.
(3) (4) [Revoked] This regulation applies to the following medicines: aspirin, and its salts; and medicines containing aspirin or its salts: iron, in medicines for human use containing more than 24 milligrams of ele‐ mental iron per dose: paracetamol; and medicines containing paracetamol.
(5) This regulation applies to the following classes of medicines: barbiturates: phenothiazine, and derivatives of phenothiazine and their salts, except dime‐ thothiazine, 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 regulation 7 of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 37(2)(a)(ii): amended, on 11 October 2001, by regulation 9(b) of the Medicines Amend‐ ment Regulations 2001 (SR 2001/232).

Regulation 37(3): revoked, on 1 August 2011, by regulation 13 of the Medicines Amendment Regu‐ lations 2011 (SR 2011/245).
Part 6 Importation and transport 38 (1) Containers Every medicine imported into, or packed or consigned for transport in, New Zealand shall be securely packed in a container that is sufficiently strong to withstand, and to protect the contents from damage arising in, the ordinary course of transport.

(2) No person shall import into, or transport or cause to be transported in, New Zealand any medicine that is not packed in compliance with subclause (1).
(3) Every related product packed or consigned for transport in New Zealand shall be securely packed in a container that is sufficiently strong to withstand, and to protect the contents from damage arising in, the ordinary course of transport.

(4) No person shall transport or cause to be transported in New Zealand any rela‐ ted product that is not packed in compliance with subclause (3).
32 Version as at 16 June 2023 Medicines Regulations 1984 Part 7 r 39A Part 7 Prescriptions 39 Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines (1) An authorised prescriber (including a designated prescriber) may only pre‐ scribe a prescription medicine if the authorised prescriber— (a) is prescribing the prescription medicine— (i) for the treatment of a patient under the authorised prescriber’s care; and (ii) within, and in accordance with all conditions (if any) stated in, the authorised prescriber’s scope of practice, as determined by an authorisation granted under section 21 of the Health Practitioners Competence Assurance Act 2003 by the authority responsible for the registration of the authorised prescriber; and (b) is not prohibited by a notice under section 48(1) of the Act from pre‐ scribing that prescription medicine or any prescription medicines of a class or description that includes that prescription medicine.
(2) An authorised prescriber who is a designated prescriber may only prescribe a prescription medicine if— (a) (b) the prescription medicine is of a class or description that the designated prescriber is authorised to prescribe by regulations made under the Act; and the requirements specified in or imposed under those regulations are satisfied.

(3) A veterinarian may only prescribe a prescription medicine that is for the treat‐ ment of an animal under the veterinarian’s care.
(4) Subclause (1) does not apply to an authorised prescriber who is acting in the course of his or her employment by the Crown.

Regulation 39: substituted, on 1 December 2011, by regulation 14 of the Medicines Amendment Regulations 2011 (SR 2011/245).
39A Limit on period of supply of prescription medicines (1) An authorised prescriber may not on any occasion prescribe for any patient a quantity of any prescription medicine that exceeds— (a) (b) 6 months’ supply in the case of an oral contraceptive; or 3 months’ supply in any other case.
(2) However, the Director-General may, at his or her discretion, authorise— 33 Part 7 r 40 Medicines Regulations 1984 Version as at 16 June 2023 (a) (b) an authorised prescriber to prescribe for any patient, or any specified class or classes of patients, a quantity of a prescription medicine exceed‐ ing the period of supply in subclause (1)(a) or (b): a class of authorised prescribers to prescribe for any patient, or any spe‐ cified class or classes of patients, a quantity of a prescription medicine exceeding the period of supply in subclause (1)(a) or (b).
Regulation 39A: inserted, on 1 December 2011, by regulation 15 of the Medicines Amendment Regulations 2011 (SR 2011/245).

Prescriptions to comply with regulations Except as provided in regulation 40A, every authorised prescriber or veterinar‐ ian who issues a prescription to a person must comply with regulation 41.

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 supply in circumstances corresponding to retail sale, or the dispensing, of a medicine (other than a pre‐ scription medicine) without a prescription.

Regulation 40: substituted, on 11 October 2001, by regulation 11 of the Medicines Amendment Regulations 2001 (SR 2001/232).

Regulation 40(1): amended, on 1 August 2011, by regulation 16 of the Medicines Amendment Regu‐ lations 2011 (SR 2011/245).
Regulation 40(1): amended, on 1 October 2005, by regulation 9 of the Medicines Amendment Regu‐ lations 2005 (SR 2005/255).
40 (1) (2) (3) 40A Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed (1) Where an authorised prescriber or veterinarian finds it necessary to do so, he or she may communicate orally to a pharmacist to whom he or she is known per‐ sonally (whether in the pharmacist’s presence or by speaking to the pharmacist on the telephone) a prescription relating to a prescription medicine that the authorised prescriber or veterinarian requires urgently.
(2) Within 7 days after a communication made by an authorised prescriber or vet‐ erinarian to a pharmacist under subclause (1), the authorised prescriber or vet‐ erinarian must issue a prescription in paper or electronic form that confirms the oral communication and forward or transmit the prescription to the pharmacist.

Regulation 40A: inserted, on 11 October 2001, by regulation 11 of the Medicines Amendment Regu‐ lations 2001 (SR 2001/232).
Regulation 40A heading: amended, on 22 December 2022, by regulation 4(1) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).

Regulation 40A(1): amended, on 1 August 2011, by regulation 17 of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 40A(1): amended, on 1 October 2005, by regulation 10(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 40A(1): amended, on 1 October 2005, by regulation 10(2) of the Medicines Amendment Regulations 2005 (SR 2005/255).

34 Version as at 16 June 2023 Medicines Regulations 1984 Part 7 r 41 Regulation 40A(2): amended, on 22 December 2022, by regulation 4(2) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 40A(2): amended, on 1 August 2011, by regulation 17 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 40A(2): amended, on 1 October 2005, by regulation 10(3) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 40A(2): amended, on 1 October 2005, by regulation 10(4) of the Medicines Amendment Regulations 2005 (SR 2005/255).

41 Form of prescription (1) A prescription issued or given under these regulations must be in paper or elec‐ tronic form.
(2) Every prescription must— (a) (b) (c) [Revoked] be dated with the date on which it was issued; and set out the following information in relation to the prescriber: (i) (ii) the prescriber’s full name; and the full street address of the prescriber’s place of work or, in the absence of the prescriber having a place of work, the postal address of the prescriber; and (iii) the prescriber’s telephone number; and (d) set out— (i) (ii) the surname, each given name, and the address of the person for whose use the prescription is given; 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 sold or dispensed, or the total period of supply; and if the medicine is to be administered by injection, or by insertion into any cavity of the body, or by swallowing, indicate the dose and fre‐ quency of dose; and if the medicine is for application externally, indicate the method and fre‐ quency of use; and [Revoked] in the case of a prescription relating to the treatment of an animal,— (i) set out the surname, each given name, and the address of the owner of the animal; and (e) (f) (g) (h) (i) (j) 35 Part 7 r 42 Medicines Regulations 1984 Version as at 16 June 2023 (ii) contain the following statement, or words of similar meaning: “Not for human use”.
(3) A paper prescription must— (a) (b) be legible and indelible; and be signed physically by the prescriber in their own handwriting.

(4) An electronic prescription must be completed using, and transmitted through, an approved system.

(5) Any reference in these regulations that relates to including or recording any‐ thing in or on a prescription means, for an electronic prescription, including or recording it in the electronic records for the electronic prescription.
(6) In this regulation, approved system means a system approved by the Director- General by notice in the Gazette.

Regulation 41(1): inserted, on 22 December 2022, by regulation 5(1) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).

Regulation 41(2): amended, on 22 December 2022, by regulation 5(2) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(2)(a): revoked, on 22 December 2022, by regulation 5(3) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 41(2)(b): replaced, on 22 December 2022, by regulation 5(3) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 41(2)(c): substituted, on 1 December 2011, by regulation 18(1) of the Medicines Amend‐ ment Regulations 2011 (SR 2011/245).
Regulation 41(2)(d)(i): substituted, on 1 December 2011, by regulation 18(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 41(2)(f): substituted, on 1 December 2011, by regulation 18(3) of the Medicines Amend‐ ment Regulations 2011 (SR 2011/245).

Regulation 41(2)(i): revoked, on 1 December 2011, by regulation 18(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(2)(j)(i): substituted, on 1 December 2011, by regulation 18(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 41(3): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).

Regulation 41(4): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(5): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).

Regulation 41(6): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Dispensing of prescription medicines Except as provided in subclause (2), no person other than an authorised pre‐ scriber, veterinarian, pharmacist, pharmacy graduate, a pharmacy technician, a student, or dispensary technician may dispense a prescription medicine.
42 (1) 36 Version as at 16 June 2023 Medicines Regulations 1984 Part 7 r 42 (1A) The following persons may not dispense prescription medicines unless under the direct personal supervision of a pharmacist: (a) (b) (c) (d) dispensary technicians: pharmacy graduates: pharmacy technicians: students.
(2) An agent or employee of a veterinarian may, in any particular case, dispense any prescription medicine at the direction of the veterinarian for use in the treatment of any animal under the care of the veterinarian.
(3) Every person dispensing a prescription relating to a prescription medicine must comply with the following requirements: (a) if the prescription has been communicated orally under regulation 40A(1), the prescription must not be dispensed on more than 1 occasion before the pharmacist has received the confirmation of the prescription, as required by regulation 40A(2): (b) the following information must be recorded on the prescription: (i) (ii) (iii) (iv) the name and address of the proprietor of the business 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 prescription: (c) (d) (e) a prescription for a medicine other than an oral contraceptive must not be dispensed on any occasion after 6 months have elapsed from the date on which the prescription was issued or, if given under regulation 40A(1), communicated orally: a prescription for a medicine that is an oral contraceptive must not be dispensed on any occasion after 9 months have elapsed from the date on which the prescription was issued or, if given under regulation 40A(1), communicated orally: every paper prescription must be retained for a period of 3 years by the pharmacist on the premises on which it was dispensed or at a place approved by the Medical Officer of Health and must be kept in an orderly and consecutive manner so as to be readily available for inspec‐ tion.
(4) If an authorised prescriber or a veterinarian refers in a prescription to a medi‐ cine by its trade mark or trade name, or by reference to the name of its manu‐ facturer, a pharmacist may supply an alternative brand of medicine, provided that— (a) the authorised prescriber or veterinarian has not marked the prescription “No brand substitution permitted” or with words of similar meaning; and 37 Part 7 r 43 Medicines Regulations 1984 Version as at 16 June 2023 (b) (c) (d) (e) (f) (fa) (g) the substituted brand contains the same active ingredient or active ingre‐ dients, and no other active ingredients; and the substituted brand is in the same dose form and strength as the pre‐ scribed brand; and there is no clinical reason why the substituted brand should not be sup‐ plied; and the pharmacist records the brand substitution on the prescription; and the pharmacist dates the prescription; and for a paper prescription, the pharmacist signs the prescription; and the pharmacist informs the patient of the brand substitution.
(5) This regulation is subject to regulation 43.

Regulation 42(1): substituted, on 11 October 2001, by regulation 12(1) of the Medicines Amendment Regulations 2001 (SR 2001/232).

Regulation 42(1): amended, on 1 August 2011, by regulation 19(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 42(1): amended, on 1 October 2005, by regulation 11(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 42(1): amended, on 19 December 2002, by regulation 4(1) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).

Regulation 42(1A): inserted, on 19 December 2002, by regulation 4(2) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).

Regulation 42(2): amended, on 1 August 2011, by regulation 19(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(3): substituted, on 1 August 2011, by regulation 19(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 42(3)(a): amended, on 22 December 2022, by regulation 6(1) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 42(3)(c): amended, on 22 December 2022, by regulation 6(2) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).
Regulation 42(3)(d): amended, on 22 December 2022, by regulation 6(2) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 42(3)(e): amended, on 22 December 2022, by regulation 6(3) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 42(4): substituted, on 1 August 2011, by regulation 19(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(4)(f): amended, on 22 December 2022, by regulation 6(4) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 42(4)(fa): inserted, on 22 December 2022, by regulation 6(5) of the Medicines Amend‐ ment Regulations (No 2) 2022 (SL 2022/304).

Regulation 42(5): added, on 1 August 2011, by regulation 19(2) of the Medicines Amendment Regu‐ lations 2011 (SR 2011/245).
43 Director-General may waive certain requirements (1) Despite the requirements in regulations 41 and 42, the Director-General may, at his or her discretion,— 38 Version as at 16 June 2023 Medicines Regulations 1984 Part 7 r 44 (a) (b) authorise a form of prescription that does not comply with all or any of the requirements in regulation 41, but that is subject to any other require‐ ments that he or she thinks fit; and authorise the dispensing of prescription medicines in a manner that does not comply with all or any of the requirements in regulation 42, but that is subject to any other requirements that he or she thinks fit.
(2) A form of prescription that may be authorised under subclause (1)(a) includes, but is not limited to, an electronic form of prescription.

Regulation 43: substituted, on 1 August 2011, by regulation 20 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
44 Prescriptions for prescription medicines not required in certain cases A prescription medicine may be sold or dispensed otherwise than under a pre‐ scription given by a practitioner, registered midwife, veterinarian, or designated prescriber if it is sold to or dispensed for— (a) (b) (c) (d) (e) (f) (fa) (fb) (g) a person licensed to sell the prescription medicine by wholesale; or a person obtaining the prescription medicine for use in any process of manufacture or trade not involving the resale of the medicine; or an analyst under the Act, or a person approved by the Director-General and in charge of a laboratory maintained for the purposes of research, study, or analysis; or a hospital care operator within the meaning of section 58(4) of the Health and Disability Services (Safety) Act 2001; or a pharmacist in control of any pharmacy, or any dispensary in a hospital care institution within the meaning of section 58(4) of the Health and Disability Services (Safety) Act 2001; or an authorised prescriber or veterinarian; or [Revoked] [Revoked] a patient under his or her care by an authorised prescriber; or (ga) [Revoked] (gb) [Revoked] (h) a patient under the care of an authorised prescriber, provided that— (i) (ii) (iii) the medicine is administered by a person who has been instructed by the authorised prescriber (either verbally or in writing) to do so; and the person administering the medicine records the administration in the patient’s medical record; and the authorised prescriber records the instruction
 under subpara‐ graph (i) in the patient’s medical record; or 39 Part 7 r 44 Medicines Regulations 1984 Version as at 16 June 2023 (ha) [Revoked] (hb) [Revoked] (i) the master of a New Zealand ship within the meaning of the Maritime Transport Act 1994,— (i) (ii) if the medicine is prescribed by rules under section 36(1)(e) of that Act; or at a time before the commencement of the first rules made under section 36(1)(e) of that Act, if the medicine is authorised or required by scales issued under section 138 or
 section 239 of the Shipping and Seamen Act 1952; or the master of a foreign ship within the meaning of the Maritime Trans‐ port Act 1994, if the law of the State whose flag the ship is entitled to fly requires the master to carry the medicine; or a person for inclusion in an emergency medical kit kept or to be kept for use in any vessel to which paragraph (i) does not apply, and is so sold or dispensed pursuant to an order signed by a Medical Officer of Health; or the person in charge of an aircraft if the medicine is required to be car‐ ried on the aircraft as a condition of the issue of a certificate of air‐ worthiness; or a person for inclusion in an emergency medical kit pursuant to an order signed by a Medical Officer of Health for use in a place of a class approved by the Director-General; or a person who has previously been supplied with the medicine on the pre‐ scription of an authorised prescriber for a particular condition, and is so sold or dispensed— (i) (ii) by a pharmacist who is satisfied that the person requires an emer‐ gency supply of the medicine for that condition; and in an amount not exceeding the quantity reasonably required by that person for a period of 72 hours, or a minimum pack of a spe‐ cial container from which it is not practicable to dispense a lesser amount; or any person by a veterinarian for the treatment of an animal under the care of the veterinarian; or a person or body authorised to distribute, or a person authorised to administer, the prescription medicine in an approved immunisation pro‐ gramme.
(ia) (j) (k) (l) (m) (n) (o) Regulation 44 heading: amended, on 11 October 2001, by regulation 13(1) of the Medicines Amend‐ ment Regulations 2001 (SR 2001/232).

Regulation 44: amended, on 30 November 2000, by regulation 10(1) of the Medicines Amendment Regulations 2000 (SR 2000/220).

40 Version as at 16 June 2023 Medicines Regulations 1984 Part 7 r 44A Regulation 44(d): substituted, on 1 October 2002, by section 58(3) of the Health and Disability Ser‐ vices (Safety) Act 2001 (2001 No 93).
Regulation 44(e): substituted, on 1 October 2002, by section 58(3) of the Health and Disability Ser‐ vices (Safety) Act 2001 (2001 No 93).

Regulation 44(f): substituted, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 44(f): amended, on 1 August 2011, by regulation 21(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(fa): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 44(fb): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 44(g): substituted, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 44(ga): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(gb): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 44(h): substituted, on 1 August 2011, by regulation 21(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 44(ha): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 44(hb): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(i): substituted, on 30 November 2000, by regulation 10(2) of the Medicines Amend‐ ment Regulations 2000 (SR 2000/220).

Regulation 44(ia): inserted, on 30 November 2000, by regulation 10(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).

Regulation 44(m): amended, on 1 August 2011, by regulation 21(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(m): amended, on 1 October 2005, by regulation 12(2) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Regulation 44(n): amended, on 1 August 2011, by regulation 21(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 44(n): amended, on 17 April 1992, by regulation 3(2) of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).

Regulation 44(o): added, on 17 April 1992, by regulation 3(1) of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).
44A Administration of vaccines in approved immunisation programmes (1) Any medical practitioner or other person who is authorised by the Director- General or a Medical Officer of Health in accordance with this regulation to administer, for the purposes of an approved immunisation programme, a vac‐ cine that is a prescription medicine, may, in carrying out that immunisation programme, administer that prescription medicine otherwise than pursuant to a prescription.
41 Part 7 r 44AA Medicines Regulations 1984 Version as at 16 June 2023 (2) The Director-General or a Medical Officer of Health may authorise any person to administer a vaccine for the purposes of an approved immunisation pro‐ gramme if that person, following written application, provides documentary evidence satisfying the Director-General or the Medical Officer of Health, as the case may be, that that person— (a) (b) (c) (d) can carry out basic emergency techniques including resuscitation and the treatment of anaphylaxis; and has knowledge of the safe and effective handling of immunisation prod‐ ucts and equipment; and can demonstrate clinical interpersonal skills; and has knowledge of the relevant diseases and vaccines in order to be able to explain the vaccination to the patient, or to the parent or guardian of the patient who is to consent to the vaccination on behalf of the patient, to ensure that the patient or the parent or guardian of the patient can give informed consent to the vaccination.
(3) Subject to subclause (4), any authorisation given by the Director-General or a Medical Officer of Health under subclause (2) shall be valid for a period of 2 years and shall be subject to such conditions as the Director-General or the Medical Officer of Health, as the case may be, thinks fit.
(4) An authorisation given to any person under subclause (2) may be withdrawn at any time before its expiry if the Director-General or a Medical Officer of Health is satisfied that the authorised person has failed to comply with any con‐ dition specified by the Director-General or the Medical Officer of Health under subclause (3).

Regulation 44A: inserted, on 17 April 1992, by regulation 4 of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).
Regulation 44A(2)(a): amended, on 11 October 2001, by regulation 14 of the Medicines Amendment Regulations 2001 (SR 2001/232).

44AA Alternative authorisation of vaccinators (1) The Director-General or a Medical Officer of Health may authorise a person who meets the requirements of this regulation to— (a) (b) prepare a vaccine: administer a vaccine without a prescription.
(2) An authorised person must, at all times while performing the tasks authorised under these regulations, work under the clinical supervision and direction of a suitably qualified health practitioner.
Application for authorisation (3) In applying for authorisation, a person must provide evidence to satisfy the Director-General or the Medical Officer of Health, as the case may be,— 42 Version as at 16 June 2023 Medicines Regulations 1984 Part 7 r 44B (a) that the person has successfully completed training as approved by the Director-General for either or both of the following: (i) preparing for administration the 1 or more vaccines for which the person has applied for authorisation: (ii) administering those vaccines; and (b) that the person also has the following competencies: (i) (ii) the person can carry out basic emergency techniques, including resuscitation and the treatment of anaphylaxis; and the person has knowledge of the safe and effective handling of immunisation products and equipment.
Conditions, etc, of authorisation (4) The Director-General or the Medical Officer of Health, as the case may be,— (a) must specify in the authorisation the 1 or more vaccines that the author‐ ised person may prepare or administer (or both): (b) may, on application by the authorised person, amend the authorisation by adding or removing any vaccine.

(5) An application to add a vaccine must be made in accordance with sub‐ clause (3)(a).
(6) The Director-General or the Medical Officer of Health, as the case may be, may— (a) (b) impose conditions on an authorisation as they think fit: amend or revoke any condition by written notice to the authorised per‐ son.

(7) An authorisation is valid for a period of 2 years, unless it is revoked earlier under subclause (8).
(8) The Director-General or the Medical Officer of Health, as the case may be, may revoke an authorisation by written notice to the authorised person if satis‐ fied that the authorised person has failed to comply with any condition on their authorisation.

Regulation 44AA: inserted, on 19 May 2022, by regulation 4 of the Medicines Amendment Regula‐ tions 2022 (SL 2022/116).

44AB Authorisation of COVID-19 vaccinators [Revoked] Regulation 44AB: revoked, on 1 June 2023, by regulation 44AB(5).
44B Duty to supply information (1) The Medical Officer of Health may require any authorised prescriber to supply information relating to the prescribing, administering, or supplying of any pre‐ scription medicines if the Medical Officer of Health has reason to suspect that 43 Part 7A r 44C Medicines Regulations 1984 Version as at 16 June 2023 prescription medicines may have been improperly prescribed, administered, or supplied by the authorised prescriber.
(2) (3) Every requirement to supply information must be in writing, stating the reasons for the Medical Officer of Health’s suspicion.

The information that must be supplied is information justifying the prescrip‐ tion, administering, or supply of the prescription medicines as follows: (a) (b) (c) (d) (e) 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.
(4) An authorised prescriber to whom any such notice is sent must supply the required information in writing to the Medical Officer of Health within 30 days.

Regulation 44B: inserted, on 18 September 1997, by regulation 2(1) of the Medicines Amendment Regulations 1997 (SR 1997/165).

Regulation 44B(1): amended, on 1 October 2005, by regulation 13(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44B(4): amended, on 1 October 2005, by regulation 13(2) of the Medicines Amendment Regulations 2005 (SR 2005/255).

Part 7A Export of prescription medicines Part 7A: inserted, on 3 November 2000, by regulation 11 of the Medicines Amendment Regulations 2000 (SR 2000/220).
44C No export of prescription medicines for retail sale without New Zealand prescription (1) No person may export a prescription medicine in the course or for the purpose of retail sale, otherwise than under a prescription given by a practitioner, a registered midwife, or a designated prescriber.

The meaning of retail sale in subclause (1) must be determined by reference to section 5(2) of the Act.
Subclause (1) is intended to limit the sale and supply of prescription medicines pursuant to section 33(b) of the Act.

Regulation 44C: inserted, on 3 November 2000, by regulation 11 of the Medicines Amendment Regulations 2000 (SR 2000/220).

(2) (3) 44 Version as at 16 June 2023 Medicines Regulations 1984 Part 8 r 45 Part 7B Supply of restricted medicine and pharmacy-only medicine Part 7B: inserted, on 18 September 2004, by regulation 3 of the Medicines Amendment Regulations 2004 (SR 2004/300).
44D Supply of restricted medicine and pharmacy-only medicine (1) A person may, in the course of any business carried on by that person, supply a restricted medicine or pharmacy-only medicine if he or she— (a) is authorised to supply the medicine in accordance with a standing order; and (b) supplies that medicine in accordance with that standing order.
(2) The circumstances in which a person may supply a restricted medicine or phar‐ macy-only medicine under subclause (1) are in addition to the circumstances in which a person may supply a restricted medicine or pharmacy-only medicine under section 18(1)(b) or (c) of the Medicines Act 1981.

Regulation 44D: inserted, on 18 September 2004, by regulation 3 of the Medicines Amendment Regulations 2004 (SR 2004/300).
Part 8 Licences 45 (1) Application for licence to manufacture, hawk, sell, or pack medicine Every application for a licence to manufacture, hawk, sell, or pack medicine must— (a) (b) (c) be made in form 1 of Schedule 2: be accompanied by the appropriate fee: specify— (i) (ii) the premises the applicant intends to use for the activity to which the application relates; or in the case of an application for a licence to hawk medicines, the area in which the applicant intends to operate: (d) specify the medicines, or the descriptions or classes of medicines, that the applicant proposes to manufacture, hawk, sell, or pack: (e) specify— (i) (ii) the applicant’s qualifications; or if the applicant is a body corporate, the qualifications of every person who will, if the application is successful, be a responsible person for the purposes of the licence to which the application relates: 45 Part 8 r 45A Medicines Regulations 1984 Version as at 16 June 2023 (f) in the case of an application for a licence to sell any medicine by retail or to hawk any medicine, be accompanied by a certificate of character that states that the applicant— (i) (ii) (iii) is well known to the person giving the certificate; and is of good character; and is considered by the person giving the certificate to be a fit and proper person to be licensed to sell or hawk medicine.
(2) A licence to undertake an activity referred to in subclause (1) may only be granted in respect of 1 place of business.
(3) Despite subclause (2), the licensing authority may grant a licence that allows for the manufacture of medicine, or a description or class of medicines, at more than 1 place of business if— (4) (5) (a) (b) the application to which the licence relates is made by a body corporate; and the licensing authority is satisfied that the body corporate has taken steps to ensure appropriate supervision of the manufacture of the product at each of the places of business.
Every applicant for a licence under this regulation must provide the licensing authority with the following things if required by the licensing authority under section 51 of the Act: (a) (b) further information: an opportunity to inspect the applicant’s premises and equipment.
The licensing authority may, in order to determine if a person to whom section 51(1)(d) of the Act applies has a sufficient knowledge of the obligations of a licensee and of the hazards associated with the medicines to which a licence to manufacture, hawk, sell, or pack medicine relates, require that person to under‐ take and pass any oral, written, or practical tests that the licensing authority considers reasonably necessary in the particular case.
Regulation 45: substituted, on 18 September 2004, by regulation 4 of the Medicines 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) be made,— (i) (ii) in the case of a company, in form 1A of Schedule 2; and in the case of a person (including a body corporate that is not a company), in form 1B of Schedule 2; and (b) be accompanied by— (i) (ii) the appropriate fee prescribed in Schedule 5A; and a completed statutory declaration (as set out in the relevant form).
46 Version as at 16 June 2023 Medicines Regulations 1984 Part 8 r 46 (2) A licence to operate a pharmacy may only be granted in respect of 1 place of business.

(3) (4) Every applicant for a licence under this regulation must provide the licensing authority with the following things if required by the licensing authority under section 51 of the Act: (a) (b) further information: an opportunity to inspect the applicant’s premises and equipment.
The licensing authority may, in order to determine if a person to whom section 51(1)(d) of the Act applies has a sufficient knowledge of the obligations of a licensee and of the hazards associated with the medicines to which a licence to operate a pharmacy relates, require that person to undertake and pass any oral, written, or practical tests that the licensing authority considers reasonably necessary in the particular case.
Regulation 45A: inserted, on 18 September 2004, by regulation 4 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Regulation 45A(1)(b)(i): substituted, on 21 August 2006, by regulation 4 of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
45B Licences that relate to CBD products (1) A licence to manufacture medicines, to sell medicines by wholesale, to pack medicines, or to operate a pharmacy that is issued under these regulations does not apply to a CBD product (as defined by section 2A of the Misuse of Drugs Act 1975) unless expressly authorised by the licence.
(2) The licence must not be issued, or amended, to expressly authorise its applica‐ tion to a CBD product unless the product has been assessed as complying with the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.
(3) A product is assessed as complying with the minimum quality standard under those regulations if— (a) (b) an application is made under those regulations to assess the CBD prod‐ uct, in which case those regulations (including the requirement to pay fees) apply for that purpose as if the product were being assessed as a medicinal cannabis product; and the Director-General assesses the evidence in the application and is satis‐ fied that a representative sample of at least 10% of each of 3 batches of the product complied with the minimum quality standard.
Regulation 45B: inserted, on 1 April 2020, by regulation 85 of the Misuse of Drugs (Medicinal Can‐ nabis) Regulations 2019 (LI 2019/321).
46 (1) Form and conditions of licence The following licences must be in the following forms: (a) a licence to manufacture medicines must be in form 2 of Schedule 2: 47 Part 8 r 47 Medicines Regulations 1984 Version as at 16 June 2023 (b) (c) (d) (e) (f) a licence to hawk medicines must be in form 3 of Schedule 2: a licence to sell medicines by wholesale must be in form 4 of Schedule 2: a licence to sell medicines by retail must be in form 5 of Schedule 2: a licence to pack medicines must be in form 6 of Schedule 2: a licence to operate a pharmacy must be in form 7 of Schedule 2.
(2) On granting a licence under the Act, the licensing authority may impose such conditions as he thinks fit.

Regulation 46(1): substituted, on 18 September 2004, by regulation 5 of the Medicines Amendment Regulations 2004 (SR 2004/300).
47 (1) Licence to manufacture medicines Every application for a licence to manufacture any medicine shall specify which of the following descriptions or classes the medicine comes within or belongs to: (a) (b) (c) (d) (e) (f) antibiotics and preparations of antibiotics: vaccines and sera: sterile preparations: hormones and steroid preparations: preparations, other than vitamins, that have a dose of 5 milligrams or less per unit dose: antineoplastic agents and immunosuppressant agents, other than steroid preparations: (g) other medicines.
(2) Where an application to manufacture medicines applies to 1 or more medicines or descriptions or classes of medicines, the licensing authority may grant a licence for all the medicines or descriptions or classes of medicines to which the application relates, or for such of the medicines or descriptions or classes of medicines to which the application relates as the licensing authority is satisfied the applicant is qualified to manufacture and capable of manufacturing.
Licence to hawk certain medicines Subject to subclause (2), and without affecting the generality of regulation 46(2), every licence to hawk any prescription medicine, restricted medicine, or pharmacy-only medicine shall be granted subject to the following conditions: (a) (b) the licence shall apply only to those medicines or descriptions or classes of medicine specified in the licence: the licensee shall keep the stocks of medicines in a place approved by the licensing authority: 48 (1) 48 Version as at 16 June 2023 Medicines Regulations 1984 Part 8 r 49 (c) (d) where the licensing authority imposes a limit on the quantity of medi‐ cines that may be carried by the licensee when hawking, the licensee shall not carry medicines in excess of that quantity: the licensee shall hawk medicines only to those persons or classes of persons specified in the licence.
(2) No person shall be granted a licence to hawk any prescription medicines, restricted medicines, or pharmacy-only medicines by retail.
48A Licensing authority to be advised of change in particulars relating to operating pharmacy (1) A company or person who is granted a licence to operate a pharmacy must advise the licensing authority as soon as practicable of any change in the details that relate to the application for that licence (including, without limita‐ tion, changes in the details of any additional information required by the licens‐ ing authority).
(2) A company that is granted a licence to operate a pharmacy under section 55D(2)(a) of the Act must immediately advise the licensing authority if there is a change or are changes in the ownership of the share capital of the company that means that more than 50% of the share capital is no longer owned by a pharmacist or pharmacists.

(3) The requirement imposed by subclause (2) is in addition to the requirement imposed by subclause (1).
Regulation 48A: inserted, on 18 September 2004, by regulation 6 of the Medicines Amendment Regulations 2004 (SR 2004/300).

49 (1) Surrender of licence Subclause (1A) applies if a licensee ceases to— (a) manufacture, hawk, sell, or pack any medicine; or (b) operate a pharmacy.

(1A) If this subclause applies, the licensee must, within 7 days of ceasing to under‐ take the activity to which the licence relates, surrender that licence to the licensing authority.
(2) The licensing authority, on receiving a licence pursuant to subclause (1A), shall retain the licence for the remainder of the current licence period.

(3) Nothing in this regulation shall prevent a licensee who has surrendered his licence pursuant to subclause (1A) from applying to the licensing authority for restoration of the licence to the licensee at any time during the current licence period.
(4) In any such case, but subject to subclause (5), the licensing authority, on being satisfied that the licensee complies with the requirements of the Act and these regulations relating to the granting of licences, shall restore the licence to the licensee.
49 Part 9 r 50 Medicines Regulations 1984 Version as at 16 June 2023 (5) Notwithstanding anything in these regulations, it shall not be necessary for any licensee who surrenders his licence to pay a further licence fee on application for restoration of that licence.

Regulation 49(1): substituted, on 18 September 2004, by regulation 7(1) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).
Regulation 49(1A): inserted, on 18 September 2004, by regulation 7(1) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Regulation 49(2): amended, on 18 September 2004, by regulation 7(2) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Regulation 49(3): amended, on 18 September 2004, by regulation 7(3) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Part 9 Withdrawal of medicines, etc 50 Withdrawal of medicines, etc (1) The Director-General may issue to any importer, manufacturer, or seller of any medicine, related product, or medical device an order— (a) (b) (c) (d) directing the withdrawal from sale of any medicine, related product, or medical device in respect of which there is in force a notice given by the Minister under section 35 or section 37 of the Act, or of any portion of the produced quantity of any such medicine, related product, or medical device, if the Director-General believes on reasonable grounds that such withdrawal is necessary to protect the public; or directing the withdrawal from sale of any medicine, related product, or medical device, or any portion of the produced quantity of any medicine, related product, or medical device, that does not conform to the specifi‐ cations claimed for that medicine, related product, or medical device; or requiring the disposal of any medicine or related product, or any specific quantity of a medicine or related product, that has been directed to be withdrawn under paragraph (a) or paragraph (b); or requiring the disposal or destruction of any medical device, or any spe‐ cific quantity of any medical device, that has been directed to be with‐ drawn under paragraph (a) or paragraph (b).
(2) The importer, manufacturer, or seller shall, on receipt of an order made under subclause (1), advise the Director-General of the manner and time in which he proposes to comply with the order, and shall give written notice to the Director- General when the order has been complied with.

(3) Notwithstanding anything in subclause (2), the Director-General may issue directions to the recipient of an order made under subclause (1) as to the man‐ ner and time in which the order is to be complied with.
50 Version as at 16 June 2023 Medicines Regulations 1984 Part 10 r 53 Part 10 Data sheets 51 Interpretation In this Part, unless the context otherwise requires, data sheet, in relation to a medicine, means a document containing information relating to the safe and effective use of the medicine.

Regulation 51: substituted, on 1 August 2011, by regulation 22 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
52 Approval of data sheets for new medicines (1) A person who applies under section 20 or 23 of the Act for the consent of the Minister to the distribution of a prescription medicine or restricted medicine (an applicant) must include 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.
(2) On receipt of the proposed data sheet, the Minister may— (a) (b) approve the data sheet; or require the data sheet to be resubmitted for approval after such changes have been made to it as the Minister considers appropriate.

(3) Within 10 days after the Minister’s consent to the distribution of a prescription medicine or restricted medicine has been notified in the Gazette, the applicant must send to the Director-General for publication an electronic copy of the approved data sheet for that medicine.
Regulation 52: substituted, on 1 August 2011, by regulation 22 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
53 Approval of data sheets for changed medicines (1) An importer or manufacturer who gives to the Director-General a notice under section 24(1) of the Act describing a material change to a prescription medicine or restricted medicine must include with the notice a proposed revised data sheet for the medicine in such form as may be required by guidelines issued from time to time by the Ministry of Health if a revision of the data sheet is necessary or desirable because of the material change.
(2) On receipt of the proposed revised data sheet, the Director-General may— (a) (b) approve the revised data sheet; or require the revised data sheet to be resubmitted for approval after such changes have been made to it as the Director-General considers appro‐ priate.

(3) After the Director-General has approved a revised data sheet, the Director- General must give written notice of the approval to the importer or manufac‐ turer.
51 Part 10 r 54 Medicines Regulations 1984 Version as at 16 June 2023 (4) Within 10 days after receiving a notice of approval under subclause (3), the importer or manufacturer must send to the Director-General for publication an electronic copy of the approved revised data sheet.

Regulation 53: substituted, on 1 August 2011, by regulation 22 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
54 Particulars in data sheets [Revoked] Regulation 54: revoked, on 1 August 2011, by regulation 22 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).

Part 11 Records 54A Sale of Medicines Registers (1) This regulation applies to the sale of a medicine if it is— (a) (b) a restricted medicine sold by retail otherwise than under a prescription; or a prescription medicine, restricted medicine, or pharmacy-only medi‐ cine, sold by wholesale.
(2) A person who makes sales to which subclause (1) applies must— (a) maintain a Sale of Medicines Register for recording and keeping the information stated in subclause (4); and (b) ensure that the information kept in it is arranged in such a way that the information about each particular sale can be conveniently inspected, or retrieved and inspected.
(3) The register must be in 1 or more of the following forms: (a) (b) (c) a system for recording and keeping the information electronically: a book for recording and keeping the information in writing: some other system for recording and keeping the information, approved by the Director-General (either generally or in any particular case) for the purposes of this regulation.
(4) The information to be recorded and kept in relation to each sale is— 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.
(a) (b) (c) (d) (e) (f) 52 Version as at 16 June 2023 Medicines Regulations 1984 Part 11 r 57 55 (1) (2) 56 (1) Regulation 54A: inserted, on 30 November 2000, by regulation 12 of the Medicines Amendment Regulations 2000 (SR 2000/220).

Records of sales by retail or wholesale Before giving to the buyer a medicine to whose sale regulation 54A(1) applies, the person making the sale must record in the Sale of Medicines Register main‐ tained under regulation 54A(2) the information stated in regulation 54A(4).
It is not necessary to comply with subclause (1) in relation to a sale by whole‐ sale if the information stated in regulation 54A(4) can be discovered from the seller’s books and records.

Regulation 55: substituted, on 30 November 2000, by regulation 12 of the Medicines Amendment Regulations 2000 (SR 2000/220).
Record of hawker’s sales Every person who hawks any prescription medicine, restricted medicine, or pharmacy-only medicine shall keep and maintain a “Hawker’s Medicines” book that records the medicines that he hawks or has in his possession.

(2) Each page of the Hawker’s Medicines book shall— (a) (b) be in the form set out in Schedule 4: relate to only 1 form and 1 strength of 1 medicine.
(3) The particulars in the Hawker’s Medicines book shall be legibly and indelibly entered not later than the ordinary business day next following the day on which the medicine concerned was sold.
(4) Every person to whom subclause (1) applies shall— (a) (b) satisfy himself that the purchaser is entitled to the medicine; and before selling the medicine to the purchaser, obtain from the purchaser a printed request for the medicine, signed and dated by the purchaser, that contains the following particulars: (i) (ii) (iii) (iv) (v) the date of each transaction: the name of the purchaser: the address of the place of business or residence of the purchaser: the name of the medicine sold: the quantity of the medicine sold.
57 (1) Record of supplies pursuant to prescriptions Every person who dispenses or supplies any prescription medicine or restricted medicine pursuant to a prescription shall, not later than the ordinary business day next following the day on which the medicine was dispensed or supplied, record that dispensing or supply of the medicine in a “Prescriptions” register, or in such other form, or within such other period of time, as the Director- General may from time to time approve.
53 Part 11 r 58 Medicines Regulations 1984 Version as at 16 June 2023 (a) (b) (c) (d) (e) (f) (g) the date of each transaction: the name of the patient or (as the case may require) the owner of the ani‐ mal: 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 identifying number or code of the prescription.
58 (1) Records to be kept The person responsible for a record to which this Part applies must keep it for at least 3 years after it was made (or, if it is kept together with other records, for at least 3 years after the most recent of them was made).

(2) The person must keep the record— (a) (b) in a secure place at his or her place of business; or in some other place authorised by the licensing authority.
Regulation 58: substituted, on 30 November 2000, by regulation 13 of the Medicines Amendment Regulations 2000 (SR 2000/220).
Part 12 Miscellaneous 58A Substances that are not medicines or related products for purposes of Act (1) The following classes of substances are not medicines or related products for the purposes of the Act: (a) dentifrice products, provided that— (i) (ii) the dentifrice product does not contain a medicine specified in Schedule 1; and the dentifrice product is not claimed to be for use in relation to any therapeutic purpose other than one or both of the following: (A) (B) preventing dental decay: improving oral hygiene: (b) anti-dandruff hair products, provided that— (i) the hair product does not contain a medicine specified in Schedule 1; and 54 Version as at 16 June 2023 Medicines Regulations 1984 Part 12 r 58A (ii) (iii) the hair product is not claimed to be for use in relation to any ther‐ apeutic purpose except controlling dandruff; and the hair product is claimed to be effective through cleansing, moisturising, exfoliating, or drying the scalp and not through any other process: (c) anti-acne skin care products, provided that— (i) (ii) (iii) the skin care product does not contain a medicine specified in Schedule 1; and the skin care product is not claimed to be for use in relation to any therapeutic purpose except preventing acne; and the skin care product is claimed to be effective through cleansing, moisturising, exfoliating, or drying the skin and not through any other process: (d) barrier cream products, provided that— (i) (ii) (iii) the barrier cream product does not contain a medicine specified in
 Schedule 1; and the barrier cream product is not claimed to be for use in relation to any therapeutic purpose except preventing nappy rash; and the barrier cream product is claimed to be effective through pro‐ viding a barrier to the transmission of moisture and not through any other process: (e) anti-bacterial skin products, provided that— (i) (ii) the product does not contain a medicine specified in Schedule 1; and the product is not claimed to be for use in relation to any thera‐ peutic purpose except preventing the spread of bacteria (but not a named bacterium); and (iii) the product is not presented as being for use in connection with— (A) any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids; or (B) either of the procedures specified in subclause (2); and (iv) the product is not recommended for use in connection with the provision of health services (as defined in section 2 of the Health and Disability Commissioner Act 1994).
(2) The procedures referred to in subclause (1)(e)(iii)(B) are— (a) (b) 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 regulation 23 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).
55 Part 12 r 58B Medicines Regulations 1984 Version as at 16 June 2023 58B Fluoridating agents and fluoridated water not medicines or related products (1) (2) (3) This regulation applies in relation to drinking water in a drinking water supply.

Fluoridating agents for use in fluoridating drinking water are not medicines or related products for the purposes of the Act.
The addition of 1 or more fluoridating agents to drinking water does not make the drinking water a medicine or related product for the purposes of the Act.
(4) In this regulation,— drinking water has the same meaning as in section 6 of the Water Services Act 2021 drinking water supply has the same meaning as in section 9 of the Water Ser‐ vices Act 2021 fluoridating agent means— (a) (b) (c) (d) hydrofluorosilicic acid: sodium fluoride: sodium silicofluoride: any other substance that releases fluoride when added to water.

Regulation 58B: inserted, on 30 January 2015, by regulation 4 of the Medicines Amendment Regula‐ tions 2015 (LI 2015/7).
Regulation 58B(1): amended, on 15 November 2021, by section 206(2) of the Water Services Act 2021 (2021 No 36).

Regulation 58B(4) drinking water: replaced, on 15 November 2021, by section 206(2) of the Water Services Act 2021 (2021 No 36).

Regulation 58B(4) drinking water supply: replaced, on 15 November 2021, by section 206(2) of the Water Services Act 2021 (2021 No 36).
58C Substances used to terminate pregnancy are medicines Substances used to terminate a pregnancy are medicines for the purposes of the Act.

Regulation 58C: inserted, on 24 March 2020, by section 18(2) of the Abortion Legislation Act 2020 (2020 No 6).

58D Non-oral products containing nicotine are medicines (1) Products containing nicotine that are not for oral use are medicines for the pur‐ poses of the Act.

(2) To avoid doubt, oral use includes (without limitation) inhalation.
Regulation 58D: inserted, on 11 November 2020, by section 30 of the Smokefree Environments and Regulated Products (Vaping) Amendment Act 2020 (2020 No 62).

58E Medications used for assisted dying are medicines Medications, when used for assisted dying under the End of Life Choice Act 2019, are medicines for the purposes of the Act.
56 Version as at 16 June 2023 Medicines Regulations 1984 Part 12 r 61 Regulation 58E: inserted, on 7 November 2021, by regulation 4 of the Medicines (Assisted Dying Medications) Amendment Regulations 2021 (LI 2021/266).
59 (1) General sale medicines may be sold by vending machine The Director-General may, by notice in the Gazette,— (a) (b) (c) (d) approve the sale of a general sale medicine by means of a vending machine: specify any conditions to which an approval under paragraph (a) is sub‐ ject: withdraw an approval given under paragraph (a): vary or revoke any conditions specified under paragraph (b), or specify additional conditions, to which an approval under paragraph (a) is sub‐ ject.
(2) A notice given under subclause (1) takes effect on the day after the date of noti‐ fication.

Regulation 59: substituted, on 1 August 2011, by regulation 24 of the Medicines Amendment Regula‐ tions 2011 (SR 2011/245).

60 Certificate of analyst The certificate of an analyst given for the purposes of section 70 of the Act shall be in the form set out in Schedule 5.

Fees The licence fees set out in Schedule 5A are payable for the licences to which they relate.
The amount to be deposited with the Medicines Review Committee pursuant to section 13(2) of the Act shall be $9,000.

The fee to accompany an application made under section 21 of the Act for the Minister’s consent under section 20 of the Act shall be $122,625 where any active ingredient of the medicine that is the subject of the application is not generally available as at the date of that application.
The fee to accompany any other application made under section 21 of the Act for the Minister’s consent under section 20 of the Act shall be $79,877.

The fee to accompany an application made under section 21 of the Act (as applied by section 96(1) of the Act) for the Minister’s consent under section 20 of the Act in relation to a related product shall be $5,731.

The fee to accompany an application made under section 23 of the Act for the Minister’s provisional consent shall be $85,202.
The fee to accompany a notice deposited with the Director-General under sec‐ tion 24 of the Act shall be $79,877.

61 (1) (2) (3) (4) (5) (6) (7) 57 Part 12 r 61A Medicines Regulations 1984 Version as at 16 June 2023 (8) (9) The fee to accompany an application made under section 30 of the Act for the approval of a clinical trial, and of the persons (in that section called investiga‐ tors) who will conduct that trial, shall be $9,843.
For the purposes of section 70(4) of the Act, the fee for a copy of a certificate of an analyst, or (as the case may be) a copy of a report made by an analyst in respect of a sample, shall be $60.

(10) For the purposes of section 97(1) of the Act, the fee for procuring a sample of any medicine and submitting it for analysis shall be $600.
(11) For the purposes of subclause (3), not generally available means not legally available other than pursuant to an exemption granted under any or all of sec‐ tions 25, 26, 27, 28, 29, 30, 31, 32, 32A, or 33 of the Act.

Regulation 61: substituted, on 29 August 1991, by regulation 2 of the Medicines Regulations 1984, Amendment No 4 (SR 1991/134).

Regulation 61(1): substituted, on 21 August 2006, by regulation 5(1) of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(3): amended, on 21 August 2006, by regulation 5(2) of the Medicines (Fees) Amend‐ ment Regulations 2006 (SR 2006/188).

Regulation 61(4): amended, on 1 July 2022, by regulation 6(1) of the Medicines Amendment Regula‐ tions 2022 (SL 2022/116).

Regulation 61(5): amended, on 1 July 2022, by regulation 6(2) of the Medicines Amendment Regula‐ tions 2022 (SL 2022/116).

Regulation 61(6): amended, on 1 July 2022, by regulation 6(3) of the Medicines Amendment Regula‐ tions 2022 (SL 2022/116).
Regulation 61(7): amended, on 1 July 2022, by regulation 6(4) of the Medicines Amendment Regula‐ tions 2022 (SL 2022/116).

Regulation 61(8): amended, on 21 August 2006, by regulation 5(6) of the Medicines (Fees) Amend‐ ment Regulations 2006 (SR 2006/188).

61A Waiver and refund of fees (1) (2) The Director-General may, in a particular case or class of cases, waive or refund, in whole or in part, any fee otherwise payable under regulation 61.
In exercising his or her powers under subclause (1), the Director-General shall have regard to— (a) (b) the time reasonably required to consider any application made or notice given under the Act: the degree of complexity involved in considering any such application or notice: (c) the interests of public health in New Zealand.

Regulation 61A: inserted, on 29 August 1991, by regulation 2 of the Medicines Regulations 1984, Amendment No 4 (SR 1991/134).
61B Fees inclusive of goods and services tax The fees fixed by these regulations are inclusive of goods and services tax under the Goods and Services Tax Act 1985.

58 Version as at 16 June 2023 Medicines Regulations 1984 Part 12 r 64 Regulation 61B: inserted, on 29 August 1991, by regulation 2 of the Medicines Regulations 1984, Amendment No 4 (SR 1991/134).
62 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) (b) such properties are, before or at the time of sale, quantitatively described to the purchaser in writing in terms that can be measured by scientific physical means; and the medical device demonstrably has the properties claimed and described.
63 Restriction on, and supervision of, compounding medicine (1) A dispensary technician must not undertake any process of compounding a medicine.

(2) The following persons may compound a medicine, but only if under the direct personal supervision of a pharmacist: (a) (b) (c) (d) pharmacy graduates: pharmacy technicians: students: despite subclause (1), dispensary technicians who have served an apprenticeship in pharmacy under the Pharmacy Act 1939.
Regulation 63: substituted, on 19 December 2002, by regulation 6 of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
64 (1) Offences Every person commits an offence against these regulations who— (a) (b) (c) contravenes or fails to comply with any of the provisions of regulations 26(1), 26(2), 27, 28(3), 29, 30, 31(5), 32(1), 32(2), 33(1), 33(2), 33(3), 34, 35(1), 35(3), 35(7), 35(9), 35(10), 36, 37(1), 39, 39A(1), 40(1), 40A(2), 42(1), 42(3), 42(4), 44B(4), and 49(1); or fails to comply with any order made by the Director-General under regu‐ lation 50(1); or contravenes or fails to comply with any of the provisions of regulations 50(2), 52(3), 53(4), 55(1), 56(1), 56(3), 56(4), 57(1), 58, 62, and 63.
(2) Every person who commits an offence against these regulations is liable on conviction to a fine not exceeding $500.

59 Part 12 r 65 Medicines Regulations 1984 Version as at 16 June 2023 Regulation 64(1)(a): amended, on 1 August 2011, by regulation 25(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 64(1)(a): amended, on 11 October 2001, by regulation 16 of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 64(1)(a): amended, on 18 September 1997, by regulation 2(2) of the Medicines Amend‐ ment Regulations 1997 (SR 1997/165).

Regulation 64(1)(c): amended, on 1 August 2011, by regulation 25(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 64(2): amended, on 1 July 2013, by section 413 of the Criminal Procedure Act 2011 (2011 No 81).
65 Appeals to District Court (1) Any occupier of premises in respect of which any decision has been made under regulation 31 by a Medical Officer of Health, may appeal against that decision to a District Court within 14 days after being notified in writing of the decision.
(2) An appeal under this regulation shall be made by way of originating applica‐ tion in accordance with the District Courts Rules 2014, and shall be filed in the office of the court nearest to the place of business or employment of the appel‐ lant.

(3) On hearing an appeal brought under this regulation, the court may confirm, reverse, or modify the decision made by the Medical Officer of Health, and the decision of the court on the appeal shall be final.
Regulation 65(2): amended, on 1 July 2014, by regulation 4 of the Medicines Amendment Regula‐ tions 2014 (LI 2014/165).

65A Transitional provision arising from enactment of Medicines Amendment Regulations 2011 [Revoked] Regulation 65A: revoked, on 16 June 2023, by regulation 5 of the Medicines Amendment Regula‐ tions 2023 (SL 2023/130).

Revocations The regulations specified in Schedule 6 are hereby revoked.

Amendment(s) incorporated in the Drug Tariff 1981 (SR 1981/171).
66 (1) (2) 60 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1AA Schedule 1AA Transitional, savings, and related provisions Schedule 1AA: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regulations 2023 (SL 2023/130).

r 2A Part 1 Provisions relating to Medicines Amendment Regulations 2023 Schedule 1AA Part 1: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regu‐ lations 2023 (SL 2023/130).
1 2 Exemption from requirement in regulation 13(1)(f) for zopiclone and zolpidem supplied before 1 July 2023 The requirement in regulation 13(1)(f) does not apply in respect of zopiclone or zolpidem supplied by a retailer, manufacturer, or wholesaler before 1 July 2023.

Schedule 1AA clause 1: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regulations 2023 (SL 2023/130).
Exemption from requirement in regulation 13(1)(f) for tramadol supplied before 1 October 2023 The requirement in regulation 13(1)(f) does not apply in respect of tramadol supplied by a retailer, manufacturer, or wholesaler before 1 October 2023.

Schedule 1AA clause 2: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regulations 2023 (SL 2023/130).
61 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 Schedule 1 Prescription, restricted, and pharmacy-only medicines r 3 Schedule 1: replaced, on 1 September 2021, by regulation 4 of the Medicines Amendment Regula‐ tions (No 2) 2021 (LI 2021/228).

Every reference to a medicine in this schedule applies whether the medicine is syn‐ thetic in origin or is from biological or mineral sources.
Unless specific reference is made otherwise, every reference applies also to medicines that are— • • • • preparations and admixtures containing any proportion of any substance listed in this schedule: salts and esters of any substance listed in this schedule: preparations or extracts of biological materials listed in this schedule: salts or oxides of elements listed in this schedule.
Unless specific reference is made otherwise, every reference to a medicine in this schedule applies,— • • if the medicine is an injection or eye preparation, to any concentration of that medicine; and if the medicine is not an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.
Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol, or element unless specifically stated otherwise.

Part 1 Prescription medicines Amending or replacing this Part may affect designated prescriber regulations under section 105(1)(q) of the Act.
19-norandrostenedione 2,4-dinitrochlorobenzene 4-aminopyridine 4-chloromethandienone 4-chlorotestosterone 5-aminolevulinic acid Abacavir Abatacept Abciximab 62 Version as at 16 June 2023 Medicines Regulations 1984 Schedule Abemaciclib Abiraterone Abrus precatorius; at all strengths Acamprosate Acarbose Acebutolol Acepromazine Acetanilides Acetarsol Acetazolamide Acetohexamide Acetylcarbromal Acetylcholine; except in medicines containing 1 milligram or less per litre or per kilogram Acetylcysteine; for injection or inhalation Acetyldigitoxin Acetylmethyldimethyloximidophenylhydrazine Acetylstrophanthidin Aciclovir; except when specified elsewhere in this schedule Acipimox Acitretin Aclidinium bromide Acokanthera ouabaio Acokanthera schimperi Aconitum spp; except when specified elsewhere in this schedule Acrivastine Adalimumab Adapalene; except in medicines containing 1 milligram or less per millilitre or gram and when supplied by a pharmacist in a pack containing not more than 30 grams for the treatment of comedo, popular, and pustular acne (acne vulga‐ ris) of the face, chest, or back Adefovir Adenosine; for injection Adinazolam Adiphenine 63 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 Adonis vernalis Adrafinil Adrenal extract; except for dermal use in medicines containing 0.02% or less of ketosteroids Adrenaline; in medicines containing more than 1% Adrenocortical hormones;
 except adrenal extract for dermal use containing 0.02% or less of ketosteroids Afamelanotide Afatinib Aflibercept Agalsidase Agomelatine Alatrofloxacin Albendazole Albumin; except human albumin Alclofenac Alclometasone; except when specified elsewhere in this schedule Alcohol; for injection in medicines containing more than 20% Alcuronium Aldesleukin Aldosterone; except in medicines containing 10 micrograms or less per litre or per kilogram Alectinib Alefacept Alemtuzumab Alendronic acid Alfacalcidol Alfentanil
 Alfuzosin Alglucerase Alglucosidase Alirocumab Aliskiren Alitretinoin Alkyl nitrites Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 Alkyl sulfonals Allergens Allopurinol Allylisopropylacetylurea; at all strengths Allyloestrenol Alogliptin Aloracetam Alosetron Alpelisib Alpha1-proteinase inhibitor Alphadolone Alphaxalone Alprazolam Alprenolol Alprostadil Alseroxylon Alteplase Altretamine Amantadine Ambenonium Ambrisentan Ambucetamide Ambutonium Amcinonide Amethocaine; except when specified elsewhere in this schedule; for ophthal‐ mic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board Amfebutamone Amfepramone 100 Amidopyrine 101 Amifampridine 102 Amifostine 103 Amikacin 104 Amiloride 105 Aminocaproic acid 65 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 106 Aminoglutethimide 107 Aminometradine 108 Aminophenazone; at all strengths 109 Aminophylline; except when specified elsewhere in this schedule 110 Aminopterin 111 Aminorex 112 Aminosalicylic acid 113 Amiodarone 114 Amiphenazole 115 Amisometradine 116 Amisulpride 117 Amitriptyline 118 Amlodipine 119 Ammi visnaga 120 Ammonium bromide 121 Amobarbital 122 Amodiaquine 123 Amorolfine; except when specified elsewhere in this schedule; except in prep‐
 arations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board 124 Amoxapine 125 Amoxycillin 126 Amphomycin 127 Amphotericin 128 Ampicillin 129 Amprenavir 130 Amrinone 131 Amsacrine 132 Amygdalin; at all strengths 133 Amyl nitrite; except when sold to a person who is appropriately authorised under the Health and Safety at Work Act 2015 134 Amylocaine 135 Anabolic steroids 136 Anagrelide 137 Anakinra 66 Version as at 16 June 2023 138 Anastrozole
 139 Ancestim Medicines Regulations 1984 Schedule 1 140 Anchusa officinalis; at all strengths 141 Ancrod and its immunoglobulin antidote 142 Androgenic and anabolic steroidal agents 143 Androgens 144 Androisoxazole 145 Androstanolone 146 Androstenediol 147 Androstenedione 148 Anecortave 149 Angiotensinamide 150 Anidulafungin 151 Aniracetam 152 Anistreplase 153 Antazoline; except for ophthalmic use 154 Antibiotic substances; except when specified elsewhere in this schedule 155 Antigens 156 Antihistamines; except when specified elsewhere in this schedule 157 Antimony; except in medicines containing 1 milligram or less per litre or per kilogram 158 Antisera; for injection 159 AOD-9604 160 Apalutamide 161 Apixaban 162 Apocynum spp 163 Apomorphine; except in medicines containing 1 milligram or less per litre or per kilogram 164 Apraclonidine 165 Apremilast 166 Aprepitant 167 Apronal 168 Aprotinin 169 Arecoline 170 Aripiprazole 67 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 171 Aristolochia spp; at all strengths 172 Aristolochic acid; at all strengths 173 Armodafinil 174 Arsenic; except in medicines containing 1 milligram or less per litre or per kilogram 175 Artemether 176 Artemisia annua extract 177 Artesunate 178 Articaine; except when used as a local anaesthetic in practice by a dental thera‐ pist or oral health therapist registered with the Dental Council 179 Asenapine 180 Asfotase alfa 181 Asparaginase 182 Aspirin; except when specified elsewhere
 in this schedule; for injection; when combined with caffeine, paracetamol, or salicylamide 183 Astemizole 184 Asunaprevir 185 Atamestane 186 Atazanavir 187 Atenolol 188 Atezolizumab 189 Atomoxetine 190 Atorvastatin 191 Atosiban 192 Atovaquone 193 Atracurium 194 Atropa belladonna; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram 195 Atropine; except when specified elsewhere in this schedule;
 except when used as an antidote in a device designed for self-injection; except in medicines con‐ taining 300 micrograms or less per litre or per kilogram 196 Atropine methonitrate 197 Auranofin 198 Aurothiomalate sodium 199 Avanafil 68 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 200 Avelumab 201 Avibactam 202 Aviptadil 203 Axitinib 204 Azacitidine 205 Azacyclonol 206 Azapropazone 207 Azaribine 208 Azatadine; except when specified elsewhere in this schedule 209 Azathioprine 210 Azelaic acid; except when specified elsewhere in this schedule 211 Azelastine; except when specified elsewhere in this schedule 212 Azithromycin 213 Azlocillin 214 Aztreonam 215 Bacampicillin 216 Bacitracin 217 Baclofen 218 Baloxavir marboxil 219 Balsalazide 220 Bambuterol 221 Bamethan 222 Bamipine 223 Bamlanivimab 224 Barbital 225 Barbiturates 226 Baricitinib 227 Basiliximab 228 Bazedoxifene 229 Becaplermin 230 Beclamide 231 Beclomethasone; except when specified elsewhere in this schedule 232 Bedaquiline 233 Belatacept 234 Belimumab 69 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 235 Bemegride 236 Benactyzine 237 Benazepril 238 Bendamustine 239 Bendrofluazide 240 Benethamine penicillin 241 Benorylate 242 Benoxaprofen 243 Benperidol 244 Benralizumab 245 Benserazide 246 Benzathine penicillin 247 Benzatropine 248 Benzbromarone 249 Benzhexol 250 Benzilonium 251 Benzocaine; except when specified elsewhere in this schedule 252 Benzodiazepine
 derivatives; except when specified elsewhere in this schedule 253 Benzodiazepines; except when specified elsewhere in this schedule 254 Benzoyl metronidazole 255 Benzoyl peroxide; except when specified elsewhere in this schedule 256 Benzthiazide 257 Benzydamine; except when specified elsewhere in this schedule 258 Benzylpenicillin 259 Bepridil 260 Beractant 261 Besifloxacin 262 Beta carotene; in medicines containing more than 18 milligrams per recom‐ mended daily dose 263 Betahistine 264 Betaine; for the treatment of
 homocystinuria 265 Betamethasone 266 Betaxolol 267 Bethanechol 268 Bethanidine 70 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 269 Bevacizumab 270 Bevantolol 271 Bexarotene 272 Bezafibrate 273 Bezlotoxumab 274 Bicalutamide 275 Bictegravir 276 Bifonazole; except when specified elsewhere in this schedule 277 Bilastine; except when specified elsewhere in this schedule 278 Bimatoprost 279 Binimetinib 280 Biperiden 281 Bismuth; except for external use in medicines containing 3% or less 282 Bisoprolol 283 Bithionol; at all strengths 284 Bivalirudin 285 Bleomycin 286 Blinatumomab 287 Boceprevir 288 Bolandiol 289 Bolasterone 290 Bolazine 291 Boldenone 292 Bolenol 293 Bolmantalate 294 Boron, including borax and boric acid; except in medicines for internal use containing 6 milligrams or less per recommended daily dose; except in medi‐ cines for dermal use other than paediatric use containing 0.35% or less; except when present as an excipient 295 Bortezomib 296 Bosentan 297 Bosutinib 298 Botulinum toxins 299 Brentuximab vedotin 300 Bretylium 71 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 301 Brexpiprazole 302 Brigatinib 303 Brimonidine 304 Brinzolamide 305 Brivaracetam (and its stereoisomers) 306 Brolucizumab 307 Bromazepam 308 Bromocriptine 309 Bromoform 310 Brompheniramine; except when specified elsewhere in this schedule 311 Bromvaletone 312 Brotizolam 313 Brugmansia spp 314 Buclizine; except for oral use 315 Budesonide; except
 when specified elsewhere in this schedule 316 Bufexamac; except in suppositories; except for dermal use in medicines con‐ taining 5% or less 317 Bumetanide 318 Buniodyl sodium; at all strengths 319 Buphenine 320 Bupivacaine 321 Buprenorphine 322 Bupropion 323 Buserelin 324 Buspirone 325 Busulphan 326 Butacaine 327 Butobarbital 328 Butoconazole; except for vaginal use 329 Butorphanol 330 Butyl aminobenzoate; except in medicines for dermal use containing 2% or less 331 Butyl nitrite 332 Butylchloral hydrate
 333 Cabazitaxel 72 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 334 Cabergoline 335 Cabotegravir 336 Cabozantinib 337 Cacalia spp; at all strengths 338 Cadmium 339 Calcipotriol; except in medicines containing not more than 50 micrograms per gram or per millilitre and when sold in a pack of not more than 30 grams or 30 millilitres by a pharmacist to an adult with mild to moderate psoriasis previ‐ ously diagnosed by a doctor 340 Calcitonin 341 Calcitriol 342 Calcium carbimide 343 Calcium polystyrene sulphonate 344 Calotropis gigantea 345 Calotropis procera 346 Calusterone 347 Camazepam 348 Camphorated oil 349 Camphotamide 350 Canagliflozin 351 Canakinumab 352 Candesartan 353 Candicidin 354 Cannabidiol 355 Capecitabine 356 Capreomycin 357 Captodiame 358 Captopril 359 Capuride 360 Caramiphen 361 Carbachol 362 Carbamazepine 363 Carbaryl; except for external use in medicines containing 2% or less 364 Carbazochrome 365 Carbenicillin 73 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 366 Carbenoxolone; except for external use 367 Carbetocin 368 Carbidopa 369 Carbimazole 370 Carbocromen 371 Carboplatin 372 Carboprost 373 Carbromal 374 Carbutamide 375 Carbuterol 376 Carfilzomib 377 Carglumic acid 378 Carindacillin 379 Carisoprodol 380 Carmustine 381 Carprofen 382 Carvedilol 383 Caspofungin 384 Catumaxomab 385 Cebaracetam (and its stereoisomers) 386 Cedazuridine 387 Cefacetrile 388 Cefaclor 389 Cefaloridine 390 Cefamandole 391 Cefapirin
 392 Cefazolin 393 Cefepime 394 Cefetamet 395 Cefixime 396 Cefodizime 397 Cefonicid 398 Cefoperazone 399 Cefotaxime 400 Cefotetan 74 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 401 Cefotiam 402 Cefoxitin 403 Cefpirome 404 Cefpodoxime 405 Cefsulodin 406 Ceftaroline fosamil 407 Ceftazidime 408 Ceftibuten 409 Ceftolozane 410 Ceftriaxone 411 Cefuroxime 412 Celecoxib 413 Celiprolol 414 Cenegermin 415 Cephaelis acuminata; except in medicines containing less than 0.2% of emetine 416 Cephaelis
 ipecacuanha; except in medicines containing less than 0.2% of emet‐ ine 417 Cephalexin 418 Cephalothin 419 Cephradine 420 Ceritinib 421 Cerivastatin 422 Cerliponase alfa 423 Certolizumab pegol 424 Ceruletide 425 Cetirizine; except when specified elsewhere in this schedule 426 Cetrorelix 427 Cetuximab 428 Chenodeoxycholic acid 429 Chloral hydrate; except for dermal use in medicines containing 2% or less 430 Chloralformamide 431 Chloralose 432 Chlorambucil 75 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 433 Chloramphenicol; except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when specified elsewhere in this schedule 434 Chlorandrostenolone 435 Chlorazanil 436 Chlorcyclizine 437 Chlordiazepoxide 438 Chlormerodrin 439 Chlormethiazole 440 Chlormezanone 441 Chloroform; for anaesthesia; except when specified elsewhere in this schedule 442 Chloroquine 443 Chlorothiazide 444 Chlorotrianisene 445 Chloroxydienone 446 Chloroxymesterone 447 Chlorpheniramine; except when specified elsewhere in this schedule 448 Chlorphentermine 449 Chlorpromazine 450 Chlorpropamide 451 Chlorprothixene 452 Chlorquinaldol 453 Chlortetracycline 454 Chlorthalidone 455 Chlorzoxazone 456 Cholera vaccine; except in the form of an oral liquid containing vibrio cholerae when sold in a pharmacy by a registered pharmacist 457 Cholic acid 458 Choline salicylate; except in medicines containing 10% or less and in pack sizes of 15
 grams or less 459 Chorionic gonadotrophin; except in pregnancy test kits 460 Chymopapain 461 Ciclacillin 462 Ciclesonide 463 Ciclopirox; except when specified elsewhere in this schedule 76 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 464 Cidofovir 465 Cilastatin 466 Cilazapril 467 Cilnidipine 468 Cilostazol 469 Cimetidine; except when specified elsewhere in this schedule 470 Cinacalcet 471 Cinchocaine; for injection; for ophthalmic use; for external use in medicines containing more than
 0.5% 472 Cinchophen 473 Cinnarizine 474 Cinoxacin 475 Ciprofloxacin 476 Cisapride 477 Cisatracurium 478 Cisplatin 479 Citalopram 480 CJC-1295 481 Cladribine 482 Clarithromycin 483 Clavulanic acid 484 Clemastine; except for oral use 485 Clemizole 486 Clenbuterol 487 Clevidipine 488 Clidinium 489 Clindamycin 490 Clioquinol; at all strengths 491 Clobazam 492 Clobetasol 493 Clobetasone; except when specified elsewhere in this schedule 494 Clocortolone 495 Clodronic acid 496 Clofarabine 497 Clofazimine 77 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 498 Clofenamide 499 Clofibrate 500 Clomiphene 501 Clomipramine 502 Clomocycline 503 Clonazepam 504 Clonidine 505 Clopamide 506 Clopidogrel 507 Clorazepic acid 508 Clorexolone 509 Clorprenaline 510 Clostebol 511 Clotiazepam 512 Clotrimazole; except when specified elsewhere in this schedule 513 Cloxacillin 514 Cloxazolam 515 Clozapine 516 Cobalt 517 Cobicistat 518 Cobimetinib 519 Cocaine; except when specified elsewhere in this schedule 520 Codeine 521 Co-dergocrine 522 Colaspase 523 Colchicine 524 Colchicum 525 Colecalciferol; except in medicines containing 25 micrograms or less per rec‐ ommended daily dose; except in parenteral nutrition replacement preparations 526 Colestipol 527 Colestyramine 528 Colfosceril 529 Colistin 530 Collagen; in injections or implants for tissue augmentation or cosmetic use 531 Collagenase clostridium histolyticum 78 Version as at 16 June 2023 Medicines Regulations 1984
 Schedule 1 532 Coluracetam 533 Conium maculatum; at all strengths 534 Convallaria keiski 535 Convallaria majalis 536 Corifollitropin alfa 537 Coronilla spp 538 Corticosterone 539 Corticotrophin 540 Cortisone and other steroidal hormones of the adrenal cortex; except when spe‐ cified elsewhere in this schedule; except adrenal extract for dermal use in med‐ icines containing 0.02% or less of ketosteroids 541 Cotarnine; at all strengths 542 Co-trimoxazole 543 Coumarin 544 COVID-19 vaccines; except when administered
 by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the COVID-19 Vaccinator Education Course (or any equivalent training course on COVID-19 vaccination approved by the Ministry of Health) and who com‐ ply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course or the COVID-19 Vaccinator - Working under Supervision Course) 545 Crisaborole 546 Crizotinib 547 Crofelemer 548 Crotalaria spp; at all strengths 549 Croton tiglium; except in medicines containing 1 milligram or less per litre or per kilogram 550 Crystal violet 551 Curare 552 Cyclandelate 553 Cyclizine; except when specified elsewhere in this schedule 554 Cyclobenzaprine 555 Cyclofenil 556 Cycloheximide 557 Cyclopenthiazide 558 Cyclopentolate; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board 79 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 559 Cyclophosphamide 560 Cyclopropane 561 Cycloserine 562 Cyclosporin 563 Cyclothiazide 564 Cycrimine 565 Cymarin 566 Cynoglossum spp; at all strengths 567 Cyproheptadine; except for oral use 568 Cyproterone 569 Cysteamine 570 Cytarabine 571 Dabigatran 572 Dabrafenib mesilate 573 Dacarbazine 574 Daclatasvir 575 Daclizumab 576 Dactinomycin 577 Dalfopristin 578 Dalteparin 579 Danaparoid 580 Danazol 581 Danthron 582 Dantrolene 583 Dapagliflozin 584
 Dapoxetine 585 Dapsone 586 Daptomycin 587 Daratumumab 588 Darbepoetin 589 Darifenacin 590 Darolutamide 591 Darunavir 592 Dasabuvir 593 Dasatinib 80 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 594 Datura spp; except for oral use when specified elsewhere in this schedule; except datura stramonium or datura tatula for smoking or burning 595 Daunorubicin 596 Deanol 597 Debrisoquine 598 Decamethonium 599 Decitabine 600 Deferasirox 601 Deferiprone 602 Defibrotide 603 Deflazacort 604 Degarelix
 605 Dehydrochloromethyltestosterone 606 Dehydrocorticosterone 607 Delavirdine 608 Delorazepam 609 Demecarium 610 Demeclocycline 611 Denosumab 612 Deoxycortone 613 Deoxycholic acid; for injection; except for oral use 614 Deoxyribonuclease; except for external use 615 Dermatophagoides farina allergen extract 616 Dermatophagoides pteronyssinus allergen extract 617 Desferrioxamine 618 Desflurane 619 Desipramine 620 Desirudin 621 Deslanoside 622 Desloratadine; except for oral use 623 Deslorelin 624 Desmopressin 625 Desogestrel; except when supplied for oral contraception to women who meet the clinical and eligbility criteria of the Pharmacy Council and the Pharmaceut‐ ical Society of New Zealand Incorporated approved training programme on 81 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 oral contraception, when sold in the manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharma‐ cist who has successfully completed the approved training programme 626 Desonide 627 Desoximetasone 628 Desvenlafaxine 629 Dexamethasone 630 Dexamfetamine 631 Dexchlorpheniramine; except when specified elsewhere in this schedule 632 Dexfenfluramine 633 Dexmedetomidine 634 Dextromethorphan; except when specified elsewhere in this schedule 635 Dextromoramide 636 Dextropropoxyphene 637 Dextrorphan 638 Di-iodohydroxy quinoline; except when
 specified elsewhere in this schedule 639 Di-isopropylamine dichloroacetate 640 Diazepam 641 Diazoxide 642 Dibenzepin 643 Dibotermin 644 Dibrompropamidine; except for ophthalmic use 645 Dichloralphenazone 646 Dichlorophen 647 Dichlorphenamide 648 Diclofenac; in preparations for the treatment of solar keratosis; except when specified elsewhere in this schedule; except in preparations for topical use other than for the treatment of solar keratosis 649 Dicloxacillin 650 Dicyclomine 651 Didanosine 652 Dienoestrol
 653 Dienogest 654 Diethazine 655 Diethylcarbamazine 82 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 656 Diethylstilbestrol 657 Diflorasone 658 Diflucortolone 659 Diflunisal 660 Digitalis lanata 661 Digitalis purpurea 662 Digitoxin 663 Digoxin 664 Digoxin-specific antibody fragment 665 Dihydralazine 666 Dihydrocodeine 667 Dihydroergotoxine 668 Dihydrolone 669 Dihydrotachysterol 670 Diltiazem 671 Dimenhydrinate; except when specified elsewhere in this schedule 672 Dimercaprol 673 Dimethandrostanolone 674 Dimethazine 675 Dimethindene; except for oral use 676 Dimethothiazine 677 Dimethoxanate 678 Dimethyl fumarate 679 Dimethyl sulphoxide 680 Dimiracetam (and its stereoisomers) 681 Dinitrocresols 682 Dinitronaphthols 683 Dinitrophenols 684 Dinitrothymols 685 Dinoprost 686 Dinoprostone 687 Diperodon 688 Diphemanil; except for dermal use 689 Diphenhydramine; except when specified elsewhere in this schedule 690 Diphenidol 83 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 691 Diphenoxylate; except when specified elsewhere in this schedule 692 Diphenylpyraline 693 Diphtheria, tetanus, and pertussis (acellular, component) vaccine; except when administered in a single dose to a person 18 years of age or over or to a preg‐ nant woman aged 13 years or over by a registered pharmacist who has success‐ fully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with
 the immu‐ nisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Provisional Vaccinator Foundation Course) 694 Diphtheria toxoid 695 Diphtheria vaccine 696 Dipivefrin 697 Dipyridamole 698 Dirithromycin 699 Disopyramide 700 Distigmine 701 Disulfiram 702 Disulphamide 703 Ditiocarb 704 DMHA, including the isomers 2-amino-6-methylheptane (also known as 1,5- dimethylhexylamine, and octodrine) and 2-amino-5-methylheptane (also known as 1,4-dimethylhexylamine) 705 Dobutamine
 706 Docetaxel 707 Dofetilide 708 Dolasetron 709 Doliracetam (and its stereoisomers) 710 Dolutegravir 711 Domperidone 712 Donepezil 713 Dopamine 714 Dopexamine 715 Doravirine 716 Doripenem 717 Dornase 718 Dorzolamide 84 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 719 Dothiepin 720 Doxantrazole 721 Doxapram 722 Doxazosin 723 Doxepin 724 Doxorubicin 725 Doxycycline 726 Doxylamine; except when specified elsewhere in this schedule 727 Dronedarone 728 Droperidol 729 Drospirenone 730 Drostanolone 731 Drotrecogin 732 Duboisia leichhardtii; except when specified elsewhere in this schedule 733 Duboisia myoporides; except when specified elsewhere in this schedule 734 Dulaglutide 735 Dulcin; at all strengths 736 Duloxetine 737 Dupilumab 738 Dupracetam 739 Durvalumab 740 Dutasteride 741 Dydrogesterone 742 Econazole; except when specified elsewhere in this schedule 743 Ecothiopate 744 Ectylurea 745 Eculizumab 746 Edetic acid; except in medicines containing 0.25% or less; except in contact lens preparations; except dicobalt edetate for the treatment of cyanide poison‐ ing 747 Edoxudine 748 Edrophonium 749 Efalizumab 750 Efavirenz 751 Eflornithine 85 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 752 Elbasvir 753 Eletriptan 754 Elosulfase alfa 755 Elotuzumab 756 Eltrombopag olamine 757 Eluxadoline 758 Elvitegravir 759 Emepronium 760 Emetine; except in medicines containing 0.2% or less 761 Emicizumab 762 Empagliflozin 763 Emtricitabine 764
 Enalapril 765 Enasidenib 766 Encorafenib 767 Enestebol 768 Enflurane 769 Enfuvirtide 770 Enobosarm 771 Enoxacin 772 Enoxaparin 773 Enoximone 774 Enprostil 775 Entacapone 776 Entecavir 777 Entrectinib 778 Enzalutamide 779 Ephedrine 780 Epicillin 781 Epinastine 782 Epirubicin 783 Epitiostanol 784 Eplerenone 785 Epoetins 786 Epoprostenol 86 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 787 Eprosartan 788 Eptifibatide 789 Erenumab 790 Ergocalciferol; except in medicines containing 25
 micrograms or less per rec‐ ommended daily dose 791 Ergometrine 792 Ergot 793 Ergotamine 794 Ergotoxine 795 Eribulin 796 Erlotinib 797 Ertapenem 798 Ertugliflozin 799 Erysimum spp; except in medicines containing 1 milligram or less per litre or per kilogram 800 Erythromycin 801 Erythropoietin 802 Escitalopram 803 Esketamine 804 Esmolol 805 Esomeprazole; except when specified elsewhere in this schedule 806 Estazolam 807 Estramustine 808 Estropipate 809 Etanercept 810 Ethacrynic acid 811 Ethambutol 812 Ethamivan 813 Ethanolamine; for injection 814 Ethchlorvynol 815 Ether; for anaesthesia; except when specified elsewhere in this schedule 816 Ethinamate 817 Ethinyloestradiol; except when supplied at a strength of 35 micrograms or less in combination with either levonorgestrel or norethisterone for oral contracep‐ tion to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated 87 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 approved training programme on oral contraception, when sold in the manufac‐ turer’s original pack that has received the consent of the Minister or Director- General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme 818 Ethionamide 819 Ethisterone 820 Ethoglucid 821 Ethoheptazine 822 Ethopropazine 823 Ethosuximide 824 Ethotoin 825
 Ethoxzolamide 826 Ethyl chloride; for inhalation 827 Ethyl loflazepate 828 Ethyldienolone 829 Ethylhexanediol; at all strengths 830 Ethyloestrenol 831 Ethynodiol 832 Etidocaine 833 Etidronic acid; except in medicines for external use containing 1% or less 834 Etilefrine 835 Etiracetam 836 Etodolac 837 Etofenamate; except for external use 838 Etomidate 839 Etonogestrel 840 Etoposide 841 Etoricoxib 842 Etravirine 843 Etretinate 844 Everolimus 845 Evolocumab 846 Exemestane 847 Exenatide 88 Version as at 16 June
 2023 848 Ezetimibe Medicines Regulations 1984 Schedule 1 849 Factor VIII inhibitor bypassing fraction 850 Famciclovir; except when specified elsewhere in this schedule 851 Famotidine; except when specified elsewhere in this schedule 852 Fampridine 853 Farfugium japonicum; at all strengths 854 Fasoracetam (and its stereoisomers) 855 Febuxostat 856 Felbamate 857 Felbinac; except for external use 858 Felodipine 859 Felypressin; except when combined with a local anaesthetic and used in prac‐ tice by a dental therapist or oral health therapist registered with the Dental Council 860 Fenbufen 861 Fenclofenac 862 Fenfluramine 863 Fenofibrate 864 Fenoldopam 865 Fenoprofen 866 Fenoterol 867 Fenpipramide 868 Fenpiprane 869 Fentanyl 870 Ferric carboxymaltose 871 Ferric derisomaltose 872 Fexofenadine; except when specified elsewhere in this schedule 873 Fibrin 874 Fibrinolysin; except for external use 875 Fibroblast growth factor 876 Fidaxomicin 877 Filgrastim 878 Finasteride 879 Fingolimod 880 Flecainide 89 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 881 Fleroxacin 882 Floctafenine 883 Fluanisone 884 Flubromazolam 885 Fluclorolone 886 Flucloxacillin 887 Fluconazole; except when specified elsewhere in this schedule 888 Flucytosine 889 Fludarabine 890 Fludiazepam 891 Fludrocortisone 892 Flufenamic acid 893 Flumazenil 894 Flumethasone 895 Flumethiazide 896 Flunarizine 897 Flunisolide 898 Flunitrazepam 899 Fluocinolone 900 Fluocinonide 901 Fluocortin 902
 Fluocortolone 903 Fluorescein; for injection 904 Fluorides; for internal use in medicines containing more than 0.5 milligrams per dose unit except in medicines containing 15 milligrams or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for exter‐ nal use in medicines containing more than 5.5 grams per litre or per kilogram except when supplied to a dental professional registered with the Dental Coun‐ cil 905 Fluorometholone 906 Fluorouracil 907 Fluoxetine 908
 Fluoxymesterone 909 Flupenthixol 910 Fluphenazine 911 Flurandrenolone 90 Version as at 16 June 2023 912 Flurazepam Medicines Regulations 1984 Schedule 1 913 Flurbiprofen; except when specified elsewhere in this schedule 914 Fluroxene 915 Fluspirilene 916 Flutamide 917 Fluticasone; except when specified elsewhere in this schedule 918 Fluvastatin 919 Fluvoxamine 920 Folic acid; except when specified elsewhere in this schedule 921 Folinic acid; except when specified elsewhere in this schedule 922 Follicle-stimulating hormone; except in medicines containing 100 micrograms or less per litre or per kilogram 923 Follistatin 924 Follitropin 925 Follitropin delta 926 Fomepizole 927 Fomivirsen 928 Fondaparinux 929 Fonturacetam (and its stereoisomers) 930 Formebolone 931 Formestane 932 Formoterol 933 Fosamprenavir 934 Fosaprepitant 935 Foscarnet 936 Fosfestrol 937 Fosfomycin 938 Fosinopril 939 Fosnetupitant 940 Fosphenytoin 941 Fotemustine 942 Framycetin 943 Fremanezumab 944 Fulvestrant 945 Furaltadone 91 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 946 Furazabol 947 Furazolidone 948 Furosemide 949 Fusidic acid 950 Gabapentin 951 Galantamine 952 Galanthus spp 953 Galcanezumab 954 Gallamine 955 Galsulfase 956 Ganciclovir 957 Ganirelix 958 Gatifloxacin 959 Gefitinib 960 Gemcitabine 961 Gemeprost 962 Gemfibrozil 963 Gemifloxacin 964 Gemtuzumab ozogamicin 965 Gentamicin 966 Gestodene 967 Gestonorone 968 Gestrinone 969 Ghrelin 970 Gilteritinib 971 Gitalin 972 Glatiramer
 acetate 973 Glecaprevir 974 Glibenclamide 975 Glibornuride 976 Gliclazide 977 Glimepiride 978 Glipizide 979 Glisoxepide 980 Glutathione; for injection 92 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 981 Glyceryl trinitrate; for injection; for transdermal use; except in medicines con‐ taining 100 micrograms or less per litre or per kilogram 982 Glycopyrronium 983 Glymidine 984 Golimumab 985 Gonadorelin 986 Gonadotrophic hormones; except when specified elsewhere in this schedule 987
 Goserelin 988 Gramicidin 989 Granisetron 990 Grazoprevir 991 Grepafloxacin 992 Griseofulvin 993 Growth hormone releasing hormones 994 Growth hormone releasing peptide-6 995 Growth hormone releasing peptides 996 Guaifenesin; except when specified elsewhere in this schedule 997 Guanabenz 998 Guanethidine 999 Guanfacine 1000 Guanidine 1001 Guselkumab 1002 Hachimycin 1003 Haematin 1004 Haemophilus influenzae vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds 1005 Halazepam 1006 Halcinonide 1007 Halofantrine 1008 Halofenate 1009 Haloperidol; except in medicines containing 1 milligram or less per litre or per kilogram 1010 Halothane 1011 Haloxazolam 1012 Halquinol; except for external use 93 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1013 Heliotropium spp; at all strengths 1014 Hemerocallis 1015 Heparins; except when present as an excipient; except for external use 1016 Hepatitis A vaccine 1017 Hepatitis B vaccine 1018 Hetacillin 1019 Hexachlorophane; in medicines containing more than 3%; except when speci‐ fied elsewhere in this schedule 1020 Hexamethonium 1021 Hexarelin 1022 Hexetidine; except for external use 1023 Hexobendine 1024 Hexocyclium 1025 Hexoprenaline 1026 Hexaminolevulinate 1027 Histamine; except in medicines containing 0.5% or less 1028 Homatropine 1029 Human chorionic gonadotrophin; except in pregnancy test kits 1030 Human growth hormone secretagogues 1031 Human papillomavirus vaccine; except when
 administered by a registered pharmacist or registered intern pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Pro‐ visional Vaccinator Foundation Course) 1032 Human protein C 1033 Hyaluronic acid; in injections or implants for tissue augmentation or cosmetic use 1034 Hydralazine 1035
 Hydrargaphen 1036 Hydrochlorothiazide 1037 Hydrocortisone; except when specified elsewhere in this schedule 1038 Hydrocyanic acid; except when specified elsewhere in this schedule 1039 Hydroflumethiazide 1040 Hydromorphone 1041 Hydroquinone; except when specified elsewhere in this schedule 94 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1042 Hydroxychloroquine 1043 Hydroxyephedrine 1044 Hydroxyphenamate 1045 Hydroxyprogesterone 1046 Hydroxystenozol 1047 Hydroxyurea 1048 Hydroxyzine 1049 Hylan polymer; in injections or implants for tissue augmentation or cosmetic use 1050 Hyoscine; except when specified elsewhere in this schedule; except in medi‐ cines containing 300 micrograms or less per litre or per kilogram 1051 Hyoscine butylbromide; except when specified elsewhere in this schedule 1052 Hyoscyamine; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less per litre or per kilogram 1053 Hyoscyamus niger; except when specified elsewhere in this schedule 1054 Hypothalamic releasing factors 1055 Hypromellose; for injection; except in intraocular viscoelastic products 1056 Ibandronic acid 1057 Ibogaine 1058 Ibritumomab tiuxetan 1059 Ibrutinib 1060 Ibufenac 1061 Ibuprofen; except when specified elsewhere in this schedule 1062 Ibutamoren 1063 Ibuterol 1064 Ibutilide 1065 Icatibant 1066 Idarubicin 1067 Idarucizumab 1068 Idebenone 1069 Idelalisib 1070 Idoxuridine; except for dermal use in medicines containing
 0.5% or less 1071 Idursulfase 1072 Ifosfamide 1073 Iloprost 95 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1074 Imatinib 1075 Imiglucerase 1076 Imipenem 1077 Imipramine 1078 Imiquimod 1079 Immunoglobulins 1080 Imuracetam 1081 Indacaterol 1082 Indapamide 1083 Indinavir 1084 Indocyanine green 1085 Indomethacin; except when specified elsewhere in this schedule 1086 Indoprofen 1087 Indoramin 1088 Infliximab 1089 Influenza and coryza vaccines; for injection; for nasal use 1090 Influenza
 vaccine; except when administered by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Pro‐ visional Vaccinator Foundation Course) 1091 Ingenol mebutate 1092 Inotuzumab ozogamicin 1093 Insulin degludec 1094 Insulin-like growth factors; except when specified elsewhere in this schedule 1095 Insulins 1096 Interferons 1097 Interleukins 1098 Iodothiouracil 1099 Ipamorelin 1100 Ipecacuanha; except when specified elsewhere in this schedule 1101 Ipilimumab 1102 Ipratropium; except for nasal use 1103 Ipriflavone 1104 Iprindole 96 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1105 Iproniazid 1106 Irbesartan 1107 Irinotecan 1108 Iron; except when specified elsewhere in this schedule 1109 Isatuximab 1110 Isavuconazole 1111 Isoaminile 1112 Isoamyl nitrite 1113 Isobutyl nitrite 1114 Isocarboxazid 1115 Isoconazole; except when specified elsewhere in this schedule 1116 Isoetarine 1117 Isoflurane 1118 Isometheptene 1119 Isoniazid 1120 Isoprenaline 1121 Isoprinosine 1122 Isopropamide; except when specified elsewhere in this schedule 1123 Isosorbide dinitrate 1124 Isosorbide mononitrate 1125 Isotretinoin 1126 Isoxicam 1127 Isoxsuprine 1128 Isradipine 1129 Itraconazole 1130 Ivabradine 1131
 Ivacaftor 1132 Ivermectin 1133 Ixabepilone 1134 Ixazomib 1135 Ixekizumab 1136 Japanese encephalitis vaccine 1137 Juniperus sabina; at all strengths 1138 Kanamycin 1139 Ketamine 97 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1140 Ketanserin 1141 Ketazolam 1142 Ketoconazole; except when specified elsewhere in this schedule 1143 Ketoprofen; except when specified elsewhere in this schedule 1144 Ketorolac 1145 Ketotifen; except for ophthalmic use in medicines containing 0.025% or less 1146
 Khellin 1147 Labetalol 1148 Lacidipine 1149 Lacosamide 1150 Lamivudine 1151 Lamotrigine 1152 Lanadelumab 1153 Lanatosides 1154 Lanreotide 1155 Lansoprazole; except when specified elsewhere in this schedule 1156 Lanthanum 1157 Lapatinib 1158 Laronidase-rch 1159 Laropiprant 1160 Larotrectinib 1161 Latamoxef 1162 Latanoprost 1163 Laudexium 1164 Lauromacrogols; for injection 1165 Lead 1166 Ledipasvir 1167 Lefetamine 1168 Leflunomide 1169 Lenalidomide 1170 Lenograstim 1171 Lenvatinib 1172 Lepirudin 1173 Leptazol 1174 Lercanidipine 98 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1175 Lesinurad 1176 Letermovir 1177 Letrozole 1178 Leucovorin; for injection 1179 Leuprorelin 1180 Levallorphan 1181 Levamisole 1182 Levetiracetam 1183 Levobunolol 1184 Levobupivacaine 1185 Levocabastine; except for nasal or ophthalmic use 1186 Levocetirizine; except for oral use 1187 Levodopa 1188 Levomepromazine 1189 Levomilnacipran 1190 Levonorgestrel; except when specified elsewhere in this schedule; except in medicines for use as emergency post-coital contraception when sold by nurses recognised by their professional body as having competency in the field of sex‐ ual and reproductive health; except when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health; except when supplied for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical
 Society of New Zealand Incorporated approved training programme on oral contraception, when sold in the manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medi‐ cines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme 1191 Levosimendan 1192 Lidoflazine 1193 Lidocaine; for injection except when used as a local anaesthetic in practice by a nurse whose scope of
 practice permits the performance of general nursing functions or by a podiatrist registered with the Podiatrists Board or by a dental therapist or an oral health therapist registered with the Dental Council; for oph‐ thalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for oral use except in throat loz‐ enges containing 30 milligrams or less per dose form; for external use in medi‐ cines containing more than 10%; except in throat sprays in medicines contain‐ ing 2% or less; except when specified elsewhere in this schedule 1194 Lifitegrast 99 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1195 Ligularia dentata; at all strengths 1196 Linaclotide 1197 Linagliptin 1198 Lincomycin 1199 Lindane; except for external use in medicines containing 2% or less 1200 Linezolid 1201 Liothyronine 1202 Lipegfilgrastim 1203 Liraglutide 1204 Lisdexamfetamine 1205 Lisinopril 1206 Lisuride 1207 Lithium; except when specified elsewhere in this schedule; except when present as an excipient in dermal medicines containing 0.25% or less 1208 Lixisenatide 1209 Lodoxamide; except in medicines for ophthalmic use 1210 Lofexidine 1211 Lomefloxacin 1212 Lomustine 1213 Loperamide; except when specified elsewhere in this schedule 1214 Lopinavir 1215 Loprazolam 1216 Loracarbef 1217 Loratadine; except when specified elsewhere in this schedule 1218 Lorazepam 1219 Lorlatinib 1220 Lormetazepam 1221 Losartan 1222
 Loteprednol 1223 Lovastatin; except when present as an unmodified, naturally occurring sub‐ stance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches 1224 Loxapine 1225 Lumacaftor 100 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1226 Lumefantrine 1227 Lumiracoxib 1228 Lurasidone 1229 Luteinising hormone 1230 Lymecycline 1231 Macitentan 1232 Mafenide 1233 Mannomustine 1234
 Maprotiline 1235 Maraviroc 1236 Mazindol 1237 Measles vaccine; except when administered, in combination with mumps and rubella vaccines in a combination product the supply of which the Minister of Health has consented to, by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course) 1238 Mebanazine 1239 Mebeverine 1240 Mebhydrolin 1241 Mebolazine 1242 Mebutamate 1243 Mecamylamine 1244 Mecasermin 1245 Mecillinam 1246 Meclocycline 1247 Meclofenamate 1248 Meclofenoxate 1249 Meclozine; except when specified elsewhere in this schedule 1250 Medazepam 1251 Medigoxin 1252 Medroxyprogesterone 1253 Medrysone 1254 Mefenamic acid; except when specified elsewhere in this schedule 101 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1255 Mefloquine 1256 Mefruside 1257 Megestrol 1258 Melagatran 1259 Melanocyte stimulating compounds 1260 Melatonin; except when supplied in medicines for oral use containing 3 milli‐ grams or less per immediate release dose unit, or 2 milligrams or less per modi‐ fied release dose unit, when sold in the manufacturer’s original pack that has received consent from the Minister of Health or the Director General for the treatment
 of primary insomnia for adults aged 55 years or older for up to 13 weeks by a registered pharmacist 1261 Meldonium 1262 Melengestrol 1263 Melia azedarach; at all strengths 1264 Meloxicam 1265 Melphalan 1266 Memantine 1267 Meningococcal vaccine; except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed the Vacci‐ nator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation
 standards of the Ministry of Health (but excluding a vaccinator who has completed the Provi‐ sional Vaccinator Foundation Course) 1268 Menotrophin 1269 Mepacrine 1270 Mepenzolate 1271 Mephenesin 1272 Mephentermine 1273 Mepindolol 1274 Mepitiostane 1275 Mepivacaine 1276 Mepolizumab 1277 Meprobamate 1278 Meptazinol 1279 Mepyramine; except when specified elsewhere in this schedule 1280 Mequitazine 1281 Mercaptomerin 102 Version as at 16 June 2023 1282 Mercaptopurine Medicines Regulations 1984 Schedule 1 1283 Mercurochrome; except when specified elsewhere in this schedule 1284 Mercury; except when specified elsewhere in this schedule 1285 Meropenem 1286 Mersalyl 1287 Mesabolone 1288 Mesalazine 1289 Mesna 1290 Mestanolone 1291 Mesterolone 1292 Mestranol 1293 Metamfetamine 1294 Metamizole 1295 Metandienone 1296 Metaraminol 1297 Metenolone 1298 Metergoline 1299 Metformin 1300 Methacholine 1301 Methacycline 1302 Methadone 1303 Methallenoestril 1304 Methandriol 1305 Methanthelinium 1306 Methazolamide 1307 Methdilazine; except for oral use 1308 Methicillin 1309 Methimazole 1310 Methisazone 1311 Methixene 1312 Methocarbamol 1313 Methohexitone 1314 Methoin 1315 Methotrexate 1316 Methoxamine; except when specified elsewhere in this schedule 103 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1317 Methoxsalen 1318 Methoxyflurane 1319 Methsuximide 1320 Methyclothiazide 1321 Methyl aminolevulinate 1322 Methyl androstanolone 1323 Methyl clostebol 1324 Methyl
 mercury; except in medicines containing 300 micrograms or less per litre or per kilogram 1325 Methyl salicylate; except for external use; except for internal use when present as an excipient in medicines containing 1.04% or less per dose form 1326 Methyl trienolone 1327 Methyldopa 1328 Methylene blue; for injection 1329 Methylergometrine 1330 Methylhexanamine (1,3-dimethylamylamine (DMAA)); except when present as an unmodified, naturally occurring substance 1331 Methylnaltrexone 1332 Methylpentynol 1333
 Methylphenidate 1334 Methylphenobarbital 1335 Methylphenylpiracetam 1336 Methylprednisolone 1337 Methyltestosterone 1338 Methylthiouracil 1339 Methyprylon 1340 Methysergide 1341 Metoclopramide; except when specified elsewhere in this schedule 1342 Metolazone 1343 Metoprolol 1344 Metribolone 1345 Metrifonate 1346 Metronidazole 1347 Metyrapone 1348 Mexiletine 104 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1349 Mezlocillin 1350 Mianserin 1351 Mibefradil 1352 Mibolerone 1353 Micafungin 1354 Miconazole; except when specified elsewhere in this schedule 1355 Midazolam 1356 Midodrine 1357 Midostaurin 1358 Mifepristone 1359 Migalastat 1360 Miglitol 1361 Miglustat 1362 Milnacipran 1363 Milrinone 1364 Minocycline 1365 Minoxidil; except for dermal use in medicines containing 5% or less 1366 Mirabegron 1367 Mirtazapine 1368 Misoprostol 1369 Mitobronitol 1370 Mitomycin 1371 Mitoxantrone 1372 Mitragyna speciosa 1373 Mitragynine 1374 Mivacurium 1375 Moclobemide 1376 Modafinil 1377 Molgramostim 1378 Molindone 1379 Molracetam 1380 Mometasone; except when specified elsewhere in this schedule 1381 Monobenzone 1382 Monoclonal antibodies; except in pregnancy test kits 1383 Montelukast 105 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1384 Moperone 1385 Morazone 1386 Moricizine 1387 Morphine; except when specified elsewhere in this schedule 1388 Motrazepam 1389 Motretinide 1390 Moxifloxacin 1391 Mumps vaccine; except when administered, in
 combination with measles and rubella vaccines in a combination product the supply of which the Minister of Health has consented to, by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course) 1392
 Mupirocin 1393 Muraglitazar 1394 Muromonab 1395 Mustine 1396 Mycophenolic acid 1397 Nabilone 1398 Nabumetone 1399 Nadolol 1400 Nadroparin 1401 Nafarelin 1402 Naftidrofuryl 1403 Nalbuphine 1404 Nalidixic acid 1405 Nalmefene 1406 Nalorphine 1407 Naloxegol 1408 Naloxone; except when provided as part of an approved emergency kit for the treatment of opioid overdose 1409 Naltrexone 1410 Nandrolone 1411 Naproxen; except when specified elsewhere in this schedule 106 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1412 Naratriptan 1413 Natalizumab 1414 Natamycin 1415 Nateglinide 1416 Nebacumab 1417 Nebivolol 1418 Nebracetam (and its stereoisomers) 1419 Nedocromil 1420 Nefazodone 1421 Nefiracetam 1422 Nefopam 1423 Nelfinavir 1424 Neomycin 1425 Neostigmine 1426 Nepafenac 1427 Nepidermin 1428 Neratinib 1429 Nerium oleander 1430 Nesiritide 1431 Netilmicin 1432 Netupitant 1433 Nevirapine 1434 Nialamide 1435 Nicardipine 1436 Nicergoline 1437 Nicofuranose 1438 Nicoracetam 1439 Nicorandil 1440 Nicotine; except when specified elsewhere in this schedule; except in prepar‐ ations for oromucosal or transdermal absorption; for nasal use except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner; in medicines other than for smoking cessation 1441 Nicotinic acid except nicotinamide; except when specified elsewhere in this schedule 1442 Nicoumalone 107 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1443
 Nifedipine 1444 Nifenazone 1445 Nikethamide 1446 Nilotinib 1447 Nilutamide 1448 Nimesulide 1449 Nimetazepam 1450 Nimodipine 1451 Nimorazole 1452 Nintedanib 1453 Niraparib 1454 Niridazole 1455 Nisoldipine 1456 Nitazoxanide 1457 Nitisinone 1458 Nitrazepam 1459 Nitrendipine 1460 Nitric oxide 1461 Nitrofurantoin 1462 Nitrofurazone 1463 Nitrous oxide; when supplied for inhalation 1464 Nitroxoline 1465 Nivolumab 1466 Nizatidine; except when specified elsewhere in this schedule 1467 Nomegestrol 1468 Nomifensine
 1469 Noopept (and its stereoisomers) 1470 Noradrenaline 1471 Norandrostenolone 1472 Norbolethone 1473 Norclostebol 1474 Nordazepam 1475 Norelgestromin 1476 Norethandrolone 108 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 1477 Norethisterone; except when supplied for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated approved training pro‐ gramme on oral contraception, when sold in the manufacturer’s original pack that has received the consent of the Minister or Director-General to their distri‐ bution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme 1478 Norfloxacin 1479 Norgestrel 1480 Noribogaine 1481 Normethandrone 1482 Nortriptyline 1483 Noxiptyline 1484 Nusinersen 1485 Nux vomica; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine 1486 Nystatin; except when specified elsewhere in this schedule 1487 Obeticholic acid 1488 Obinutuzumab 1489 Ocrelizumab 1490 Ocriplasmin 1491 Octamylamine 1492 Octatropine 1493 Octreotide 1494 Octyl nitrite 1495 Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram 1496 Oestriol 1497 Oestrogens 1498 Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram 1499 Ofatumumab 1500 Ofloxacin 1501 Olanzapine 1502
 Olaparib 1503 Olaratumab 1504 Oleandomycin 109 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1505 Oleandrin 1506 Olmesartan 1507 Olodaterol 1508 Olopatadine 1509 Olsalazine 1510 Omalizumab 1511 Omberacetam 1512 Ombitasvir 1513 Omeprazole; except when specified elsewhere in this schedule 1514 Ondansetron 1515 Opipramol 1516 Opium 1517 Orciprenaline 1518 Orlistat; except in medicines for weight control containing 120 milligrams or less per dose form 1519 Ornidazole 1520 Ornipressin 1521
 Orphenadrine 1522 Orthopterin 1523 Oseltamivir; except when specified elsewhere in this schedule 1524 Osimertinib 1525 Otilonium bromide 1526 Ouabain 1527 Ovandrotone 1528 Oxabolone 1529 Oxacillin 1530 Oxaliplatin 1531 Oxandrolone 1532 Oxaprozin 1533 Oxazepam 1534 Oxazolam 1535 Oxcarbazepine 1536 Oxedrine; except in medicines containing 30 milligrams or less per recommen‐ ded daily dose 1537 Oxetacaine; except for internal use 110 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 1538 Oxiconazole; except when specified elsewhere in this schedule 1539 Oxiracetam (and its stereoisomers) 1540 Oxitropium 1541 Oxolamine 1542 Oxolinic acid 1543 Oxpentifylline 1544 Oxprenolol 1545 Oxybuprocaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board 1546 Oxybutynin 1547 Oxycodone 1548 Oxymesterone 1549 Oxymetholone 1550 Oxyphenbutazone 1551 Oxyphencyclimine 1552 Oxyphenisatin; at all strengths 1553 Oxyphenonium 1554 Oxytetracycline 1555 Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram 1556 Ozanimod 1557 Paclitaxel 1558 Palbociclib 1559 Palifermin 1560 Paliperidone 1561 Palivizumab 1562 Palonosetron 1563 Pamaquin 1564 Pamidronic acid 1565 Pancreatic enzymes; except in medicines containing 20 000 BP units or less of lipase activity 1566 Pancuronium 1567 Panitumumab 1568 Panobinostat 1569 Pantoprazole; except when specified elsewhere in this schedule 111 Schedule 1
 Medicines Regulations 1984 Version as at 16 June 2023 1570 Papaveretum 1571 Papaverine; for injection 1572 Paracetamol; except when specified elsewhere in this schedule 1573 Paraldehyde 1574 Paramethadione 1575 Paramethasone 1576 Parecoxib 1577 Paricalcitol 1578 Paritabprevir 1579 Paromomycin 1580 Paroxetine 1581 Pasireotide 1582 Patent blue V; for injection when used in diagnostic procedures 1583 Patiromer sorbitex calcium 1584 Pazopanib 1585 Pecazine 1586 Pefloxacin 1587 Pegaptanib 1588 Pegaspargase 1589
 Pegfilgrastim 1590 Peginterferon 1591 Peginterferon beta-1a 1592 Pegvisomant 1593 Pembrolizumab 1594 Pemetrexed 1595 Pemoline 1596 Pempidine 1597 Penbutolol 1598 Penciclovir; except when specified elsewhere in this schedule 1599 Penicillamine 1600 Pentaerythrityl tetranitrate 1601 Pentagastrin 1602 Pentamethonium 1603 Pentamidine 1604 Pentazocine 112 Version as at 16 June 2023 1605 Penthienate 1606 Pentolinium Medicines Regulations 1984 Schedule 1 1607 Pentosan polysulfate sodium 1608 Pentostatin 1609 Pentoxifylline 1610 Peramivir 1611 Perampanel 1612 Pergolide 1613 Perhexiline 1614 Pericyazine 1615 Perindopril 1616 Permethrin; except in medicines containing 5% or less 1617 Perphenazine 1618 Pertussis antigen 1619 Pertussis (whooping cough) vaccine 1620 Pertuzumab 1621 Pethidine 1622 Phenacemide 1623 Phenacetin; except when present as an excipient 1624 Phenaglycodol 1625 Phenazone; except for external use 1626 Phenazopyridine 1627 Phenelzine 1628 Pheneticillin 1629 Phenformin 1630 Phenglutarimide 1631 Phenibut 1632 Phenindione 1633 Pheniramine; except when specified elsewhere in this schedule 1634 Phenisatin 1635 Phenobarbital 1636 Phenol; for injection 1637 Phenolphthalein 1638 Phenoperidine 1639 Phenoxybenzamine 113 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1640 Phenoxymethylpenicillin 1641 Phensuximide 1642 Phentermine 1643 Phenthimentonium 1644 Phentolamine 1645 Phenylbutazone 1646 Phenylephrine; except when specified elsewhere in this
 schedule 1647 Phenylpiracetam 1648 Phenylpropanolamine 1649 Phenyltoloxamine 1650 Phenytoin 1651 Phleum pratense extract 1652 Pholcodine; except when specified elsewhere in this schedule 1653 Phosphodiesterase type 5 inhibitors; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in this sched‐ ule 1654 Phthalylsulfathiazole 1655 Physostigmine 1656 Pibrentasvir 1657 Picibanil 1658 Picric acid 1659 Picrotoxin 1660 Pilocarpine; except in medicines containing
 0.025% or less 1661 Pimecrolimus 1662 Pimozide 1663 Pinacidil 1664 Pinazepam 1665 Pindolol 1666 Pioglitazone 1667 Pipecuronium 1668 Pipemidic acid 1669 Pipenzolate 1670 Piperacetam 1671 Piperacillin 1672 Piperidine 114 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1673 Piperidolate 1674 Pipobroman 1675 Pipothiazine 1676 Pipradrol 1677 Piracetam 1678 Pirbuterol 1679 Pirenoxine 1680 Pirenzepine 1681 Piretanide 1682 Pirfenidone 1683 Piroxicam; except for external use 1684 Pirprofen 1685 Pitavastatin 1686 Pituitary hormones 1687 Pivampicillin 1688 Pizotifen 1689 Plerixafor 1690 Plicamycin 1691 Plitidepsin 1692 Pneumococcal vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds 1693 Podophyllotoxin; for internal use; for external use for the treatment of anogeni‐ tal warts; for other external use in medicines containing more than 1%; except in medicines containing 1 milligram or less of podophyllin per litre or per kilo‐ gram 1694 Podophyllum emodi; for internal use; for external use for the treatment of ano‐ genital warts; for other external use in medicines containing more than 20% of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram 1695 Podophyllum peltatum; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 20% of podophyllin; except in medicines containing 1 milligram or less
 of podo‐ phyllin per litre or per kilogram 1696 Polatuzumab vedotin 1697 Polidexide 1698 Poliomyelitis vaccine 115 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1699 Polyacrylamide; in injections or implants for tissue augmentation or cosmetic use 1700 Polyestradiol 1701 Polylactic acid; in injections or implants for tissue augmentation or cosmetic use 1702 Polymyxin 1703 Polysulfated glycosaminoglycans; for injection except in intraocular viscoelas‐ tic products 1704 Polythiazide 1705
 Pomalidomide 1706 Ponatinib 1707 Poractant alfa 1708 Posaconazole 1709 Potassium bromide 1710 Potassium perchlorate 1711 Practolol 1712 Pradofloxacin 1713 Pralatrexate 1714 Pralidoxime 1715 Pralmorelin 1716 Pramipexole 1717 Pramiracetam 1718 Pramocaine 1719 Prampine 1720 Prasterone 1721 Prasugrel 1722 Pravastatin 1723 Prazepam 1724 Praziquantel 1725 Prazosin 1726 Prednisolone 1727 Prednisone 1728 Pregabalin 1729 Pregnenolone 1730 Prenalterol 116 Version as at 16 June 2023 1731 Prenylamine Medicines Regulations 1984 Schedule 1 1732 Prilocaine; for injection except when used as a local anaesthetic in practice by a dental therapist or an oral therapist registered with the Dental Council; except when specified elsewhere in this schedule 1733 Primaquine 1734 Primidone 1735 Probenecid 1736 Probucol 1737 Procainamide 1738 Procaine 1739 Procaine penicillin 1740 Procarbazine 1741 Prochlorperazine; except when specified elsewhere in this schedule; except when sold for the treatment of nausea associated with emergency contraception by pharmacists or nurses accredited to sell levonorgestrel for emergency con‐ traception 1742 Procyclidine; except for dermal use in medicines containing 5% or less 1743 Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram 1744 Progestogens 1745 Proglumide 1746 Proguanil 1747 Prolintane 1748 Promazine 1749 Promethazine; except when specified elsewhere in this schedule 1750 Promoxolane 1751 Propafenone 1752
 Propamidine; except for ophthalmic use 1753 Propanidid 1754 Propantheline 1755 Propetandrol 1756 Propionibacterium acnes 1757 Propofol 1758 Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram 1759 Propylthiouracil 117 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1760 Propyphenazone 1761 Proquazone 1762 Proscillaridin 1763 Prostaglandins 1764 Protamine 1765 Prothionamide 1766 Prothipendyl 1767 Protirelin 1768 Protoveratrines 1760 Protriptyline 1770
 Proxymetacaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board 1771 Prucalopride 1772 Pseudoephedrine 1773 Pulmonaria spp; at all strengths 1774 Pyrazinamide 1775 Pyridinolcarbamate 1776 Pyridostigmine 1777 Pyridoxal; except in medicines containing 200 milligrams or less per recom‐ mended daily dose 1778 Pyridoxamine; except in medicines containing 200 milligrams or less per rec‐ ommended daily dose 1779 Pyridoxine; except in medicines containing 200 milligrams or less per recom‐ mended daily dose 1780 Pyrimethamine 1781 Pyrvinium 1782 Quazepam 1783 Quetiapine 1784 Quinagolide 1785 Quinapril 1786 Quinbolone 1787 Quinethazone 1788 Quinidine 1789 Quinine; except in medicines containing 50 milligrams or less per recommen‐ ded daily dose 1790 Quinisocaine 118 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1791 Quinupristin 1792 Rabeprazole 1793 Rabies vaccine 1794 Racetams; except when specified elsewhere in this schedule 1795 Raloxifene 1796 Raltegravir 1797 Raltitrexed 1798 Ramipril 1799 Ramucirumab 1800 Ranibizumab 1801 Ranitidine; except when specified elsewhere in this schedule 1802 Ranolazine 1803 Rapacuronium 1804 Rasagiline 1805 Rasburicase 1806 Rauwolfia serpentina 1807 Rauwolfia vomitoria 1808 Razoxane 1809 Reboxetine 1810 Recombinant human epidermal growth factor 1811 Recombinant varicella zoster virus glycoprotein E antigen 1812 Regorafenib 1813 Remdesivir 1814 Remestemcel-L
 1815 Remifentanil 1816 Remoxipride 1817 Repaglinide 1818 Reserpine 1819 Reslizumab 1820 Retapamulin 1821 Reteplase 1822 Retigabine 1823 Ribavirin 1824 Ribociclib 1825 Ridaforolimus 119 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1826 Rifabutin 1827 Rifampicin 1828 Rifamycin 1829 Rifapentine 1830 Rifaximin 1831 Rilmazafone 1832 Rilpivirine 1833 Riluzole 1834 Rimexolone 1835 Rimiterol 1836 Rimonabant 1837 Riociguat 1838 Ripretinib 1839 Risankizumab 1840 Risedronic acid 1841 Risperidone 1842
 Ritodrine 1843 Ritonavir 1844 Rituximab 1845 Rivaroxaban 1846 Rivastigmine 1847 Rizatriptan; except when specified elsewhere in this schedule 1848 Rocuronium 1849 Rofecoxib 1850 Roflumilast 1851 Rolipram (and its stereoisomers) 1852 Rolitetracycline 1853 Rolziracetam 1854 Romidepsin 1855 Romiplostim 1856 Romosozumab 1857 Ropinirole 1858 Ropivacaine 1859 Rosiglitazone 1860 Rosoxacin 120 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1861 Rosuvastatin 1862 Rotavirus vaccine 1863 Rotigotine 1864 Roxibolone 1865 Roxithromycin 1866 Rubella vaccine; except when administered, in combination with measles and mumps vaccines in a combination product the supply of which the Minister of Health has consented to, by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course) 1867 Ruboxistaurin 1868 Rufinamide 1869 Rupatadine 1870 Ruxolitnib 1871 Sabadilla; except in preparations containing 10 milligrams or less of total alka‐ loids of schoenocaulon officinale per litre or per kilogram 1872 Sacubitril 1873 Safinamide 1874 Safrole; for internal use except in medicines containing 0.1% or less 1875 Salbutamol 1876 Salcatonin 1877 Salmeterol 1878 Sapropterin 1879
 Saquinavir 1880 Sargramostim 1881 Sarilumab 1882 Saxagliptin 1883 Schoenocaulon officinale; except in preparations containing 10 milligrams or less of total alkaloids of schoenocaulon officinale per litre or per kilogram 1884 Scopolia carniolica 1885 Sebelipase alfa 1886 Secbutabarbital 1887 Secobarbital 1888 Secukinumab 121 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1889 Selective androgen receptor modulators 1890 Seletracetam (and its stereoisomers) 1891 Selegiline 1892 Selenium;
 except when specified elsewhere in this schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose 1893 Selexipag 1894 Semaglutide 1895 Serelaxin 1896 Sermorelin 1897 Sertindole 1898 Sertraline 1899 Serum, dried human 1900 Sevelamer 1901 Sevoflurane 1902 Sex hormones and all substances having sex hormone activity 1903 Sialoepoetin 1904 Sibutramine 1905 Silandrone 1906 Sildenafil and its structural analogues; except sildenafil in medicines for oral use containing 100 milligrams or less per dose unit when sold in the manufac‐ turer’s original pack containing not more than 12 solid dosage units for the treatment of erectile dysfunction in males aged 35–70 years by a registered pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand Incorporated 1907 Silicones; for injection 1908 Silodosin 1909 Siltuximab 1910 Silver sulfadiazine; except for external use in packs containing 50 grams or less 1911 Simeprevir 1912 Simvastatin 1913 Siponimod 1914 Sirolimus 1915 Sisomicin 1916 Sitagliptin 1917 Sitaxentan 1918 Sodium bromide 122 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 1919 Sodium cellulose phosphate; for internal use 1920 Sodium cromoglycate; except for nasal and ophthalmic use 1921 Sodium morrhuate; for injection 1922 Sodium nitroprusside 1923 Sodium phenylbutyrate 1924 Sodium phosphate; in oral laxative preparations 1925 Sodium polystyrene
 sulphonate 1926 Sodium tetradecyl sulphate; for injection 1927 Sodium zirconium cyclosilicate 1928 Sofosbuvir 1929 Solasadine 1930 Solifenacin 1931 Somatostatin 1932 Somatropin 1933 Sonidegib 1934 Sontoquine 1935 Sorafenib 1936 Sotalol 1937 Sparfloxacin 1938 Sparteine 1939 Spectinomycin 1940 Spiramycin 1941 Spirapril 1942 Spironolactone 1943 Squill 1944 Stanolone 1945 Stanozolol 1946 Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds 1947 Stavudine
 1948 Stenabolic (SR9009) and other synthetic REV-ERB agonists 1949 Stenbolone 1950 Steroid hormones 1951 Stilboestrol 1952 Stiripentol 123 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 1953 Stramonium; except for oral use when specified elsewhere in this schedule; except datura stramonium or datura tatula for smoking or burning 1954 Streptococcus beta-haemolyticus vaccine; except in oral vaccines for the pro‐ phylaxis of bacterial complications of colds 1955 Streptodornase 1956 Streptokinase 1957 Streptomycin 1958 Streptozocin 1959 Strontium ranelate 1960 Strophanthins 1961 Strophanthus spp 1962 Strychnos spp; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine 1963 Styramate 1964 Succimer 1965 Sufentanil 1966 Sugammadex 1967 Sulbactam 1968 Sulconazole; except for dermal use 1969 Sulfacetamide; except for ophthalmic use in medicines containing 10% or less 1970 Sulfadiazine; except silver sulfadiazine for external use in pack sizes of 50 grams or less 1971 Sulfadimethoxine 1972 Sulfadimidine 1973 Sulfadoxine 1974 Sulfafurazole 1975 Sulfaguanidine 1976 Sulfamerazine 1977 Sulfamethizole 1978 Sulfamethoxazole 1979 Sulfamethoxydiazine 1980 Sulfamethoxypyridazine 1981 Sulfametrole 1982 Sulfamonomethoxine 1983 Sulfamoxole 124 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 1984 Sulfaphenazole 1985 Sulfapyridine 1986 Sulfasalazine 1987 Sulfathiazole 1988 Sulfatroxazole 1989 Sulfinpyrazone 1990
 Sulfomyxin 1991 Sulfonmethane 1992 Sulindac 1993 Sultamicillin 1994 Sulthiame 1995 Sumatriptan; except when specified elsewhere in this schedule 1996 Sunifiram 1997 Sunitinib 1998 Suprofen 1999 Suvorexant 2000 Sutilains 2001 Suxamethonium 2002 Suxethonium 2003 T cell receptor antibody 2004 Tacrine 2005 Tacrolimus 2006 Tadalafil and its structural analogues 2007 Tafamidis 2008 Tafenoquine succinate 2009 Tafluprost 2010 Talazoparib 2011 Taliglucerase alfa 2012 Talimogene laherparepvec 2013 Tamoxifen 2014
 Tamsulosin 2015 Tanacetum vulgare; except in medicines containing 0.8% or less of oil of tansy 2016 Tapentadol 2017 Tasonermin 2018 Tazarotene 125 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 2019 Tazobactam 2020 Teduglutide 2021 Tegafur 2022 Tegaserod 2023 Teicoplanin 2024 Telaprevir 2025 Telbivudine 2026 Telithromycin 2027 Telmisartan 2028 Telotristat ethyl 2029 Temazepam 2030 Temozolomide 2031 Temsirolimus 2032 Tenecteplase 2033 Teniposide 2034 Tenofovir 2035 Tenoxicam 2036 Terazosin 2037 Terbinafine; except when specified elsewhere in this schedule 2038 Terbutaline 2039 Terfenadine 2040 Teriflunomide 2041 Teriparatide 2042 Terlipressin 2043 Terodiline 2044 Teropterin 2045 Tesamorelin 2046 Testolactone 2047 Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram 2048 Tetanus antitoxin 2049 Tetanus toxoid 2050 Tetanus vaccine 2051 Tetrabenazine 2052 Tetracosactrin 126 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 2053 Tetracycline 2054 Tetraethylammonium 2055 Tetrahydrocannabinol 2056 Tetrazepam 2057 Tetroxoprim 2058 Thalidomide 2059 Thenyldiamine 2060 Theophylline; except when specified elsewhere in this schedule 2061 Thevetia peruviana 2062 Thevetin 2063 Thiambutosine 2064 Thiazosulfone 2065 Thiethylperazine 2066 Thioacetazone 2067 Thiocarlide 2068 Thioguanine 2069 Thiomesterone 2070 Thiopentone 2071 Thiopropazate 2072 Thioproperazine 2073 Thioridazine 2074 Thiotepa 2075 Thiothixene
 2076 Thiouracil 2077 Thiourea; except in medicines containing 0.1% or less 2078 Thymosin beta-4 2079 Thymoxamine 2080 Thyroid 2081 Thyrotrophin 2082 Thyrotrophin-releasing factor 2083 Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram 2084 Tiagabine 2085 Tianeptine 2086 Tiaprofenic acid 127 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 2087 Tiaramide 2088 Tibolone 2089 Ticagrelor 2090 Ticarcillin 2091 Ticlopidine 2092 Tiemonium 2093 Tienilic acid 2094
 Tigecycline 2095 Tigloidine 2096 Tiletamine 2097 Tilidine 2098 Tilmanocept 2099 Tiludronic acid 2100 Timbetasin 2101 Timolol 2102 Tinidazole 2103 Tinzaparin 2104 Tioconazole; except when specified elsewhere in this schedule 2105 Tiotropium 2106 Tipepidine 2107 Tipiracil 2108 Tiprinavir 2109 Tirilazad 2110 Tirofiban 2111 Tivozanib 2112 Tizanidine 2113 Tobramycin 2114 Tocainide 2115 Tocilizumab 2116 Tofacitinib 2117 Tolazamide 2118 Tolazoline 2119 Tolbutamide 2120 Tolcapone 2121 Tolfenamic acid 128 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 2122 Tolmetin 2123 Tolonium 2124 Tolpropamine 2125 Tolrestat 2126 Tolterodine 2127 Tolvaptan 2128 Topiramate 2129 Topotecan 2130 Torasemide 2131 Toremifene 2132 Toxoids; for injection 2133 Tramadol 2134 Trametinib dimethyl sulfoxide 2135 Trandolapril 2136 Tranexamic acid 2137 Tranylcypromine 2138 Trastuzumab 2139 Trastuzumab emtansine 2140 Travoprost 2141 Trazodone 2142 Trenbolone 2143 Treosulphan 2144 Treprostinil 2145 Trestolone 2146 Tretamine 2147 Tretinoin 2148 Triacetyloleandomycin 2149 Triamcinolone; except when specified elsewhere in this schedule 2150 Triamterene 2151 Triaziquone 2152 Triazolam 2153 Trichlormethiazide 2154 Trichloroacetic acid; except for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts 2155 Trichloroethylene 129 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 2156 Trichodesma africana; at all strengths 2157 Triclofos
 2158 Tricyclamol 2159 Tridihexethyl 2160 Trientine 2161 Trifluoperazine 2162 Trifluperidol 2163 Triflupromazine 2164 Trifluridine 2165 Trimeprazine; except when specified elsewhere in this schedule 2166 Trimetaphan 2167 Trimethoprim; except in medicines for oral use containing 300 milligrams or less per dose unit when sold in a pack of 3 solid dosage units to a woman aged 16–65 years for the treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the
 New Zealand Col‐ lege of Pharmacists’ training in the treatment of urinary tract infections 2168 Trimipramine 2169 Trimustine 2170 Trinitrophenol 2171 Trioxysalen 2172 Triparanol; at all strengths 2173 Triple antigen vaccine 2174 Triprolidine; except when specified elsewhere in this schedule 2175 Triptorelin 2176 Troglitazone 2177 Trometamol; for injection in medicines containing more than 3% 2178 Tropicamide; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board 2179 Tropisetron 2180 Trovafloxacin 2181 Troxidone 2182 Tryptophan; except in medicines containing 100 milligrams or less per recom‐ mended daily dose; except in parenteral nutrition replacement preparations 2183 Tuberculin 2184 Tuberculosis vaccine 2185 Tubocurarine 130 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 2186 Tucatinib 2187 Tulobuterol 2188 Typhoid vaccine 2189 Ulipristal 2190 Umeclidinium bromide 2191 Unifiram 2192 Unoprostone 2193 Upadacitinib 2194 Uracil 2195 Urapidil 2196 Urethane 2197 Urofollitropin 2198 Urokinase 2199 Ursodeoxycholic acid 2200 Ustekinumab 2201 Vaccines; except when specified elsewhere in this schedule 2202 Vaccinia virus vaccine 2203 Valaciclovir 2204 Valdecoxib 2205 Valganciclovir 2206 Valnoctamide 2207 Valproic acid 2208 Valsartan 2209 Vancomycin 2210 Vandetanib 2211 Vardenafil and its structural analogues 2212 Varenicline 2213 Varicella vaccine; except when administered for the prevention of
 herpes zoster (shingles) to a person 50 years of age or over by a registered pharmacist who has successfully completed the Vaccinator Foundation Course (or any equiva‐ lent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Provisional Vaccinator Foundation Course) 2214 Vasopressin 2215 Vecuronium 2216 Vedolizumab 131 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023
 2217 Velaglucerase alfa 2218 Velpatasvir 2219 Vemurafenib 2220 Venetoclax 2221 Venlafaxine 2222 Verapamil 2223 Veratrum spp 2224 Vernakalant 2225 Verteporfin 2226 Veruprevir 2227 Vidarabine 2228 Vigabatrin 2229 Vilanterol 2230 Vildagliptin 2231 Viloxazine 2232 Vinblastine 2233 Vincamine 2234 Vincristine 2235 Vindesine 2236 Vinflunine 2237 Vinorelbine 2238 Vinyl ether 2239 Virginiamycin 2240 Vismodegib 2241 Visnadine 2242 Vitamin A; except for internal use in medicines containing 3 milligrams or less of retinol equivalents per recommended daily dose; except in parenteral nutri‐ tion replacement preparations; except for external use in medicines containing 1% or less 2243 Vitamin D; except for external use; except for internal use in medicines con‐ taining 25 micrograms or less per recommended daily dose; except in paren‐ teral nutrition replacement preparations 2244 Voglibose 2245 Vorapaxar 2246 Voretigene neparvovec 2247 Voriconazole 132 Medicines Regulations 1984 Schedule 1 Version as at 16 June 2023 2248 Vorinostat 2249 Vortioxetine 2250 Voxilaprevir 2251 Warfarin 2252 Xamoterol 2253 Xanthinol nicotinate 2254 Ximelagatran 2255 Xipamide 2256 Yellow fever vaccine 2257 Yohimbine 2258 Zafirlukast 2259 Zalcitabine 2260 Zaleplon 2261 Zanamivir 2262 Zidovudine 2263 Zimeldine 2264 Zinc; except for internal use in medicines containing 25 milligrams or less per recommended daily dose; except for internal use in medicines containing 50 milligrams or less and more than 25
 milligrams per recommended daily dose in packs that have received the consent of the Minister or the Director- General to their distribution as general sale medicines, when sold in the manu‐ facturer’s original pack and when labelled with a statement that the product may be dangerous if taken in large amounts or for long periods; except for external use when in medicines containing 5% or less; except in parenteral nutrition replacement preparations 2265 Ziprasidone 2266 Zoledronic acid 2267 Zolmitriptan; except
 when specified elsewhere in this schedule 2268 Zolpidem 2269 Zonisamide 2270 Zopiclone 2271 Zoster immunoglobulin, human 2272 Zoxazolamine 2273 Zuclopenthixol Schedule 1, Part 1 item 1090: amended, on 19 May 2022, by regulation 7 of the Medicines Amend‐ ment Regulations 2022 (SL 2022/116).
133 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 Part 2 Restricted medicines Adrenaline; in medicines containing 1% or less except in medicines for injec‐ tion containing 0.02% or less Alclometasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than 30 grams that have received the consent of the Minister or the Director-General to their distribution as restricted medicines, when sold in the manufacturer’s original pack Aminophylline; for oral use in liquid form in medicines containing 2% or less Amorolfine; for external use in medicines containing more than 0.25% Aspirin; in slow-release forms; in enteric coated forms containing more than 300 milligrams per dose form Azatadine; for oral use in adults and children over 2 years of age Azelastine; in medicines for ophthalmic use containing 0.05% or less Brompheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units Buclizine; for oral use Butoconazole; for vaginal use Chloramphenicol; for ophthalmic use; except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board Chlorbutol; except when specified elsewhere in this schedule Chlorpheniramine; for oral use in medicines for adults or children over 2 years of
 age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units Ciclopirox; for external use in medicines containing more than 2%; in prepar‐ ations for application to the nails containing more than 8% Cimetidine; in medicines for the symptomatic relief of heartburn, dyspepsia, and hyperacidity or to be used on the recommendation of a registered medical practitioner, when sold
 in the manufacturer’s original pack containing not more than 14 days’ supply Clemastine; for oral use Clobetasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than 30 grams that have received the consent of the Minister or the Director-General to their distribution as restricted medicines, when sold in the manufacturer’s original pack 18 Clotrimazole; for vaginal use 134 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 26 27 28 29 30 31 32 33 34 Cyclizine; for oral use other than in medicines used for the treatment of insom‐ nia when sold in the manufacturer’s original pack containing not more than 6 dosage units; for oral use in medicines used for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units Cyproheptadine; for oral use Dexchlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units Dextromethorphan; in liquid form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milli‐ grams; in medicines for the treatment of symptoms of cough and cold in adults and children aged six years and over Di-iodohydroxy quinoline; for vaginal use Diclofenac; in solid
 dose form in medicines containing 25 milligrams or less and more than 12.5 milligrams per dose form in packs containing not more than 30 tablets or capsules Dimenhydrinate; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule Dimethindene; for oral use Diphenhydramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when
 sold in the manufacturer’s original pack containing not more than 10 dosage units Dithranol Doxylamine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units Econazole; for vaginal use Erythrityl tetranitrate Famciclovir; in divided solid dosage forms for oral use containing 500 milli‐ grams or less for the treatment of recurrent herpes labialis when sold in the manufacturer’s original pack containing up to 3 dosage units Flavoxate Fluconazole; for oral use in medicines that have received the consent of the Minister or the Director-General to their distribution as restricted medicines, when sold in the manufacturer’s original pack containing 150 milligrams or less as a single dose for the treatment of vaginal candidiasis 135 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 Fluorides; for external use in liquid form in medicines containing 5.5 grams or less and more than 1 gram per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines; for external use in non-liquid form in medicines containing 5.5 grams or less and more than 1 gram per litre or per kilogram, except in medicines containing 1.5 grams or less and more than 1 gram per litre or per kilogram; except when
 supplied to a dental professional registered with the Dental Council Glucagon; except in medicines containing 100 micrograms or less per litre or per kilogram Glyceryl trinitrate; for oral or sublingual use; for rectal use Guaifenesin; for oral use in modified release form with a maximum recommen‐ ded daily dose of not more than 2.4 grams when sold in the manufacturer’s ori‐ ginal pack containing more than 10 days’ supply but not more than 30 days’ supply; except for oral use in modified release form with a
 maximum recom‐ mended daily dose of not more than 2.4 grams when sold in the manufacturer’s original pack containing not more than 10 days’ supply; except for oral use in medicines containing 2% or less or 200 milligrams or less per dose form Haemophilus influenzae vaccine; in oral vaccines for the prophylaxis of bacte‐ rial complications of colds Hydrocortisone and hydrocortisone acetate but no other esters of hydrocorti‐ sone; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except an anti‐ fungal and in a quantity of 30 grams or less or 30 millilitres or less per con‐ tainer; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except 5% or less by weight of aciclovir and in a quantity of 2 grams or less or 2 millilitres or less per container in adults and children 12 years of age and older; in rectal medicines containing 1% or less but more than 0.5% by weight of hydrocorti‐ sone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or up to 12 suppositories per pack Hyoscine butylbromide; for oral use in medicines containing not more than 20 milligrams per dose form and in packs containing not more than 10 tablets or capsules for the relief of muscle spasm of the gastrointestinal tract Ibuprofen; for oral use in tablets or capsules containing up to 400
 milligrams per dose form and in packs containing not more than 50 dose units and that have received the consent of the Minister or the Director-General to their distri‐ bution as restricted medicines, when sold in the manufacturer’s original pack labelled for use by adults or children over 12 years of age Inositol nicotinate Isoconazole; for vaginal use 35 36 37 38 39 40 41 42 43 44 136 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 45 46 Ketoprofen; in solid dose form containing 25
 milligrams or less per dose form in packs of not more than 30 capsules or tablets Lansoprazole; in divided solid dosage forms for oral use containing 15 milli‐ grams or less with a maximum daily dose of 15 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over for the relief of heartburn when sold in the manufacturer’s original pack containing not more than 14 dosage units 47 Levonorgestrel; in medicines for use as emergency post-coital contraception when in packs containing not more than 1.5 milligrams 48 Macrogols; in oral preparations for bowel cleansing prior to diagnostic, med‐ ical, or surgical procedures 49 Malathion; except for external use in medicines containing 2% or less 50 Mannityl hexanitrate 51 Meclozine; in a pack size of up to 10 dosage units for the treatment of insom‐ nia 52 Mepyramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack con‐ taining not more than 10 dosage units 53 Methdilazine; for oral use 54 Metoclopramide; when compounded with paracetamol in packs of not more than 10 tablets or capsules for the treatment of nausea associated with migraine 55 Miconazole; for the treatment of oral candidiasis; for vaginal use 56 57 58 59 60 61 62 63 Nicotinic acid except nicotinamide; in medicines containing 250
 milligrams or less but more than 100 milligrams per dose form; except in medicines contain‐ ing 100 milligrams or less per dose form Nicotinyl alcohol; except in medicines containing 100 milligrams or less per dose form Nystatin; for the treatment of oral candidiasis; for vaginal use Orlistat; in medicines for weight control containing 120 milligrams or less per dose form Oseltamivir; in solid dosage forms for oral use containing 75 milligrams in a pack size of up to 10 dosage units for the treatment or
 prophylaxis of influenza in adults and children aged 13 years and older who have been exposed to the influenza virus Oxiconazole; for vaginal use Paracetamol; in modified-release forms containing 665 milligrams or less Pheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for 137 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 the treatment of insomnia when sold in the manufacturer’s original pack con‐ taining not more than 10 dosage units Pneumococcal vaccine; in oral vaccines for the prophylaxis of bacterial com‐ plications of colds Podophyllotoxin; for external use for the treatment of warts other than anogeni‐ tal warts in medicines containing 1% or less and more than 0.5%; except in medicines containing 1 milligram or less of podophyllin per litre or per kilo‐ gram Podophyllum emodi; for external use for the treatment of warts other than ano‐ genital warts in medicines containing 20% or less and more than 10% of podo‐ phyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram Podophyllum peltatum; for external use for the treatment of warts other than anogenital warts in medicines containing 20% or less and more than 10% of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram Prochlorperazine; in packs containing not more than 10 tablets or capsules for
 the treatment of nausea associated with migraine Promethazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack con‐ taining not more than 10 dosage units Rizatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms, when in wafers
 containing 5 milligrams or less per wafer and when sold in a pack containing not more than 2 wafers approved by the Minister or the Director-General for distribution as a restricted medicine Salicylic acid; except in medicines for dermal use containing 40% or less Santonin Sodium phosphate; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures Sodium picosulphate; in oral preparations for bowel cleansing prior to diagnos‐ tic, medical, or surgical procedures Staphyloccocus aureus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds Stramonium; for oral use in liquid form; in solid dose form in medicines con‐ taining more than 0.3 milligrams per dose or more than 1.2 milligrams per rec‐ ommended daily dose Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds 64 65 66 67 68 69 70 71 72 73 74 75 76 77 138 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 78 79 80 81 82 83 84 85 Sulfacetamide; for ophthalmic use in medicines containing 10% or less Sumatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when in tablets containing 50 milligrams or less per tablet and when sold in a pack containing not more than 2 tablets that has received the consent of the Minister or the Director-General to its sale as a
 restricted medicine Theophylline; in liquid form for oral use in medicines containing 2% or less Tioconazole; for vaginal use Triamcinolone; for buccal use in medicines containing 0.1% or less of triamci‐ nolone acetonide and in pack sizes of 5 grams or less Trimeprazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack con‐ taining not more than
 10 dosage units Triprolidine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule Zolmitriptan; in a pre-filled nasal spray device containing not more than 5 mil‐ ligrams of zolmitriptan, for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms and when sold in a pack of not more than 2 devices approved by the Minister or the Director-General for distribution as a restricted medicine Part 3 Pharmacy-only medicines 8-hydroxyquinoline and its non-halogenated derivatives; in medicines contain‐ ing more than 1% of such substances; except for hydroxyquinoline sulphate for external use Acetic acid and preparations containing more than 80% of acetic acid (CH3COOH); excluding its salts and derivatives Acetylcysteine; for oral use in medicines containing more than 1 gram per rec‐ ommended daily dose Aciclovir; for external use for the treatment of herpes labialis except in medi‐ cines containing 5% or less and in tubes containing 10 grams or less Aconitum spp; for oral use in packs containing 0.2 milligrams or less and more than 0.02 milligrams of total alkaloids; for dermal use in concentrations of 0.02% or less and in packs containing 0.2 milligrams or less and more than 0.02 milligrams of total alkaloids Aloes; for internal use; except when obtained solely from the mucilaginous gel of the leaf Aloin 139 Schedule 1 Medicines Regulations
 1984 Version as at 16 June 2023 Aloxiprin Amethocaine; for external use in medicines containing 10% or less and more than 2%; except in medicines for external use containing 2% or less Amorolfine; in preparations for topical use; except in preparations for the treat‐ ment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board Antazoline; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
 Atropa belladonna; for external use in medicines containing 0.03% or less of the alkaloids of belladonna; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli‐ grams per recommended daily dose of the alkaloids of belladonna or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of the alkaloids of bel‐ ladonna Atropine; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recom‐ mended daily dose or in solid dose form in medicines containing 0.3 milli‐ grams or less per dose form and not more than 1.2 milligrams per recommen‐ ded daily dose; in medicines containing atropine sulphate for the treatment of organophosphorus poisoning either in packs of not more than 20 dose units containing 0.6 milligrams or less per dose unit or in injections in packs of not more than 5 vials containing 0.6 milligrams per millilitre; except when sold as an antidote in a device designed for self-injection from outlets licensed to sell organophosphorus poisons; except in medicines containing 300 micrograms or less per litre or per kilogram Azelaic acid; for dermal use Azelastine; in preparations for nasal use containing 0.15% azelastine hydro‐ chloride or less; in topical eye preparations containing 0.05% or less Beclomethasone; for the
 treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack con‐ taining 200 actuations or less Benzocaine; in preparations for topical use, other than eye drops, containing 10% or less of total anaesthetic substances except in dermal preparations con‐ taining 2% or less of total anaesthetic
 substances; in divided preparations con‐ taining 200 milligrams or less of total anaesthetic substances per dosage unit except in lozenges containing 30 milligrams or less of total anaesthetic sub‐ stances per dosage unit Benzoyl peroxide; for external use in medicines containing more than 5% and not more than 10%; except for medicines for external use containing 5% or less 140 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 26 27 28 29 30 31 32 33 34 Benzydamine; for external use except for oromucosal or topical use Bephenium Bifonazole; except when specified elsewhere in this schedule; except for der‐ mal use in medicines for tinea pedis only or in shampoos containing 1% or less or when sold in practice by a podiatrist registered with the Podiatrists Board Bilastine; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjunctivitis (sea‐ sonal and perennial) Bisacodyl Bromhexine Brompheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other thera‐ peutically active ingredients either when in the bedtime dose of a day/night pack containing brompheniramine or when at least 1 of the other active ingre‐ dients is a sympathomimetic decongestant Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of
 age in aqueous nasal sprays delivering up to 64 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) Carbetapentane; except in medicines containing 0.5% or less Carbocisteine Cetirizine; for oral use except in divided solid dosage forms for oral use con‐ taining 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing
 not more than 5 days’ supply Chlophedianol Chlorbutol; in medicines containing 5% or less and more than 0.5%; except in medicines containing 0.5% or less Chloroform; in medicines other than for anaesthesia containing more than 0.5%; except in medicines containing 0.5% or less Chlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other thera‐ peutically active ingredients either when in the bedtime dose of a day/night pack containing chlorpheniramine or when at least 1 of the other active ingredi‐ ents is a sympathomimetic decongestant Ciclopirox; for external use in medicines containing 2% or less except when for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; in preparations for application to the nails containing 8% or less 35 Cinchocaine; for external use in medicines containing 0.5% or less 141 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 Cinnamedrine Clotrimazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board Cocaine; in medicines for oral use, containing not more than 0.1% of cocaine, when combined with 1 or more active ingredients in such a way that the sub‐ stance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, and when sold in a pack approved by
 the Minister or the Director-General for distribution as a pharmacy-only medicine Colocynth Creosote; except in medicines containing 10% or less Cresols; except in medicines containing 3% or less Datura spp; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per rec‐ ommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2
 milligrams per recommended daily dose of total solanaceous alkaloids Delphinium staphisagria; except in medicines containing 0.2% or less Desloratadine; for oral use Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other thera‐ peutically active ingredients either when in the bedtime dose of a day/night pack containing dexchlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant Dextromethorphan; in liquid form containing more than 0.25% or in solid dose form containing more than 15 milligrams per dose form when in packs contain‐ ing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of the symptoms of cough and cold in children aged 6–12 years; except in liquid form containing 0.25% or less in solid dose form containing 15 milligrams or less per dose form when in packs containing not more than 600 milligrams and with a recommen‐ ded daily dose of not more than 120 milligrams Dibrompropamidine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 milligrams Diphenoxylate; in liquid
 form containing in each millilitre not more than 0.5 milligrams of diphenoxylate calculated as base and not less than 5 micro‐ grams of atropine sulphate; in solid dose form containing not more than 2.5 milligrams of diphenoxylate calculated as base and not less than 5 micro‐ grams of atropine sulphate 36 37 38 39 40 41 42 43 44 45 46 47 48 49 142 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 50 51 52 53 54 55 56 57 58 59 60 Dimenhydrinate; for oral use in a sealed container of not more
 than 10 tablets or capsules for the prevention or treatment of motion sickness in adults or chil‐ dren over 2 years of age except when sold at a transport terminal or aboard a ship or an aircraft Diphenhydramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other thera‐ peutically active ingredients either when in the bedtime dose of a day/night pack containing diphenhydramine or when at least 1 of the other active ingredi‐ ents is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a trans‐ port terminal or aboard a ship or an aircraft Doxylamine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack contain‐ ing doxylamine or when at least 1 of the other active ingredients is a sympatho‐ mimetic decongestant Duboisia leichhardtii; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli‐ grams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of
 total solanaceous alkaloids Duboisia myoporides; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli‐ grams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids Econazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a
 podiatrist registered with the Podiatrists Board Esomeprazole; in oral preparations containing 20 milligrams or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply Etafedrine Ether; in medicines containing more than 10%; except in medicines containing 10% or less Etofenamate; for external use Famotidine; for the symptomatic relief of heartburn, dyspepsia, and hyperacid‐ ity or to be used on the recommendation of a registered medical practitioner, when sold in the manufacturer’s original pack containing not more than 14 days’ supply 143 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 Felbinac; for external use Fexofenadine; for oral use except for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack contain‐ ing 20 dosage units or less and not more than 10 days’ supply; for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 milligrams or less of fexofenadine hydrochlor‐ ide with a maximum daily dose of 180 milligrams when sold in the manufac‐ turer’s original pack containing 5 dosage units or
 less and not more than 5 days’ supply Fluorides; for internal use in medicines containing 0.5 milligrams or less per dose unit; except in parenteral nutrition replacement preparations; for external use in liquid form in medicines containing 1 gram or less per litre or per kilo‐ gram and when sold in packs approved by the Minister or the Director-General for distribution as pharmacy-only medicines except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more
 than 120 milligrams of total fluoride; except when supplied to any dental professional registered with the Dental Council; except in medicines containing 15 milligrams or less per litre or per kilogram Flurbiprofen; in locally acting oromucosal preparations containing 10 milli‐ grams or less per dosage unit Fluticasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation with a maximum recommended daily dose of 200 micrograms (as a single dose) Folic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose; except for oral use in medicines containing 500 micrograms or less per recommended daily dose; except in parenteral nutrition replacement preparations Folinic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose; except for oral use in medicines containing 500 micrograms or less per recommended daily dose Formaldehyde; except in medicines containing 5% or less Gelsemium sempervirens; except in medicines containing 1 milligram or less per litre or per kilogram Glutaraldehyde Hexachlorophane; in medicines containing 3% or less but more than 0.75%; except in medicines containing 0.75% or less 61 62 63 64 65 66 67 68 69 70 71 144 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 72 73 74 75 76 77 78 Hydrocortisone and hydrocortisone acetate but no other
 esters of hydrocorti‐ sone; for dermal use in medicines containing 0.5% or less by weight of hydro‐ cortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; in rectal medicines containing 0.5% or less by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or 12 suppositories or fewer per pack Hydrocyanic acid; for oral use in packs containing 5
 milligrams or less and more than 0.5 milligrams; except in medicines containing 1 microgram or less per litre or per kilogram; except for oral use in packs containing 0.5 milligrams or less Hydroquinone; for external use in medicines containing 2% or less except in hair preparations containing 1% or less Hyoscine; for transdermal use in medicines containing 2 milligrams or less of total solanaceous alkaloids per dose unit; for oral use in liquid form in medi‐ cines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per 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 liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milli‐ grams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids Hyoscyamus niger; for oral use in liquid form in medicines containing 0.03% or less (300 micrograms or less of total solanaceous alkaloids per litre or per kilogram) and 0.3 milligrams or less per dose and not more than 1.2 milligrams
 per recommended daily dose of total solanaceous alkaloids or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose except in packs contain‐ ing 30 micrograms or less of total solanaceous alkaloids Ibuprofen; for oral use in liquid form with a recommended daily dose of not more than 1.2 grams for the relief of pain and reduction of fever or inflamma‐ tion when sold in the manufacturer’s original pack containing not more
 than 8 grams; for oral use in solid dose form containing not more than 200 milli‐ grams per dose form and with a recommended daily dose of not more than 1.2 grams when sold in the manufacturer’s original pack containing not more than 100 dose units; except in divided solid dosage forms for oral use contain‐ ing 200 milligrams or less per dose form with a recommended daily dose of not 145 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 more than 1.2 grams and when sold in the manufacturer’s original pack con‐ taining not more than 25 dose units; except for external use Indanazoline Indomethacin; for external use in medicines containing 1% or less; except in medicines containing 1 milligram or less per litre or per kilogram Iodine; except for external use in medicines containing 2.5% or less; for inter‐ nal use in medicines containing less than 300 micrograms per recommended daily dose Ipecacuanha; in medicines containing 0.2% or less of emetine and 40 micro‐ grams or more of ipecacuanha alkaloids per recommended dose for the treat‐ ment of the symptoms of cough and cold in children aged 6–12 years; except in medicines containing less than 40 micrograms of ipecacuanha alkaloids per recommended dose for the treatment of the symptoms of cough and cold in children aged 6–12 years Ipomoea spp; except ipomoea batatas Ipratropium; for nasal use Iron; for oral use either in medicines containing more than 24 milligrams per recommended daily dose or in
 medicines containing more than 5 milligrams per dose unit and more than 750 milligrams of iron per pack; except in paren‐ teral nutrition replacement preparations; except for oral use in medicines con‐ taining 24 milligrams or less per recommended daily dose in medicines con‐ taining not more than 5 milligrams per dose unit; except for oral use in medi‐ cines containing 24 milligrams or less per recommended daily dose in medi‐ cines containing more than 5 milligrams per dose unit in packs containing not more
 than 750 milligrams of iron Isoconazole; for dermal use except when sold in practice by a podiatrist regis‐ tered with the Podiatrists Board Isopropamide; for dermal use in preparations containing 2% or less Jalap resin Ketoconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; except in medicines for treatment of the scalp containing 1% or less Ketotifen; for ophthalmic use in medicines containing 0.025% or less except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board Leucovorin; in medicines containing more than 500 micrograms per recom‐ mended daily dose Levocabastine; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board 79 80 81 82 83 84 85 86 87 88 89 90 91 92 146 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 93 94 95 96 97 98 99 Levocetirizine; for oral use Lignocaine; for urethral use; for external use in medicines containing 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 less but more than 0.01%; except for dermal use in medicines containing 0.01% 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 practice by an optomet‐ rist registered with the Optometrists and Dispensing Opticians Board 100 Loperamide; in packs containing not more than 20 tablets or capsules; except in divided solid dosage forms for oral use containing 2 milligrams or less of loperamide per dosage form when sold in a pack containing not more than 8 dosage forms approved by the Minister or the Director-General for distribution as a general sales medicine for the symptomatic treatment of acute non-specific diarrhoea 101
 Loratadine; for oral use; except in divided solid dosage forms for oral use con‐ taining 10 milligrams or less per dose form for the treatment of seasonal aller‐ gic rhinitis when sold in the manufacturer’s original pack containing not more than 10 days’ supply 102 Macrogols; in preparations for oral use as a liquid concentrate for laxative use 103 Mebendazole 104 Meclozine; in a sealed container of not more than 12 tablets or capsules for the prevention or treatment of travel sickness except when sold at a transport ter‐ minal or aboard a ship or aircraft 105 Mefenamic acid; in solid dose form in packs containing not more than 30 tab‐ lets or capsules for the treatment of dysmenorrhoea 106 Mepyramine; for dermal use; except for external use in medicines containing 2% or less in packs not exceeding 25 grams 107 Mercuric oxide; for ophthalmic use 108 Mercurochrome; in preparations for external use containing 2% or less 109 Mercury; for external use in medicines containing 0.5% or less; except in med‐ icines containing 1 milligram or less per litre or per kilogram 110 Methoxamine; for external use in medicines containing more than 1%; except for external use in medicines containing 1% or less 111 Methoxyphenamine 112 Methylephedrine 113 Miconazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board 147 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 114 Minoxidil;
 for dermal use in medicines containing 5% or less 115 Mometasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 200 micrograms (as a single dose) in a pack containing 200 actuations or less 116 Morphine; in medicines for oral use containing not more than 0.2% of mor‐ phine, when combined with 1 or more active ingredients in such a
 way that the substance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine 117 Naphazoline; except for ophthalmic use when sold in practice by an optomet‐ rist registered with the Optometrists and Dispensing Opticians Board 118 Naproxen; in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules 119 Niclosamide 120 Nicotine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist, or psychologist 121 Nizatidine; in medicines for the symptomatic relief of heartburn, dyspepsia, and hyperacidity or to be used on the recommendation of a registered medical practitioner, when sold in the manufacturer’s original pack containing not more than 14 days’ supply 122 Noscapine 123 Nystatin; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board 124 Omeprazole; in divided solid dosage forms for oral use containing 20 milli‐ grams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s
 original pack containing not more than 28 dosage units 125 Opium; in medicines for oral use containing not more than 0.2% of morphine, when combined with 1 or more active ingredients in such a way that the sub‐ stance cannot be recovered by readily applicable means, or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine 126 Oxetacaine; for internal use 127 Oxiconazole; for dermal use except in
 medicines for tinea pedis only 148 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 128 Oxymetazoline; except for nasal use when sold at an airport; except for oph‐ thalmic use when sold in practice by an optometrist registered with the Optom‐ etrists and Dispensing Opticians Board; except for nasal use in medicines con‐ taining 0.05% or less when sold in the manufacturer’s original pack with a pack size of 20 millilitres or less 129 Pantoprazole; in divided solid dosage forms for oral use containing 20 milli‐ grams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s original pack containing not more than 28 dosage units 130 Papaverine; except for injection 131 Paracetamol; in liquid form; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams and not more than 50 grams; in powder form containing not more than 1 gram per sachet and more than 10 grams per pack; except in tablets or capsules contain‐ ing 500 milligrams or less and in packs containing not more than 10 grams; except in powder form in sachets containing 1 gram or less and in packs of not more than 10 grams 132 Paraformaldehyde; except in medicines containing 5% or less 133 Penciclovir; for external use for the treatment of herpes labialis; except in med‐ icines for external use containing 1%
 or less in a pack containing 10 grams or less for the treatment of herpes labialis 134 Phedrazine 135 Phenazone; for external use 136 Pheniramine; for ophthalmic use except when sold in practice by an optomet‐ rist registered with the Optometrists and Dispensing Opticians Board; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing
 pheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongest‐ ant 137 Phenol; except in medicines other than for injection containing 3% or less 138 Phenylephrine; for nasal use in medicines containing more than 1%; for oph‐ thalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 milligrams per recommended daily dose or in packs containing more than 250 milligrams of phenylephrine per pack; in medicines for the treatment of the symptoms of cough and cold in children aged 6–12 years; except for nasal or ophthalmic use in medicines containing 1% or less; except for oral use in medicines containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack 149 Schedule 1 Medicines Regulations 1984 Version as at 16 June 2023 139 Pholcodine; in medicines for oral use containing not more than 15 milligrams of pholcodine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of pholcodine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means, or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for dis‐ tribution as a pharmacy-only medicine 140 Piperazine 141 Podophyllotoxin; for external use for the treatment of warts other than
 anogeni‐ tal warts in medicines containing 0.5% or less; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram 142 Podophyllum emodi; for external use for the treatment of warts other than ano‐ genital warts in medicines containing 10% or less of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilo‐ gram 143 Podophyllum peltatum; for external use for the treatment of warts other than anogenital warts in medicines containing
 10% or less of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilo‐ gram 144 Potassium; for internal use: in slow-release or enteric coated forms; except for internal use: in medicines containing 100 milligrams or less per recommended dose; in medicines containing more than 100 milligrams per recommended dose except in medicines for oral rehydration therapy, parenteral nutrition replacement, or dialysis; except in glucosamine sulphate complexed products containing 600 milligrams or less of potassium chloride per recommended dose; except for external use 145 Potassium chlorate; except in medicines containing 10% or less 146 Prilocaine; for dermal use in medicines containing 10% or less of local anaes‐ thetic substances 147 Procyclidine; for dermal use in medicines containing 5% or less 148 Promethazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack contain‐ ing promethazine or when at least 1 of the other active ingredients is a sympa‐ thomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or aircraft 149 Propamidine; for ophthalmic use except when sold in
 practice by an optomet‐ rist registered with the Optometrists and Dispensing Opticians Board 150 Pyrantel 150 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 1 151 Pyrethrins; except in medicines containing 10% or less 152 Pyrithione zinc; except in medicines for treatment of the scalp containing 2% or less 153 Ranitidine; in medicines for the symptomatic relief of heartburn, dyspepsia, and hyperacidity or to be used on the recommendation of a registered medical practitioner when sold in the
 manufacturer’s original pack containing not more than 14 days’ supply; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply 154 Salicylamide 155 Selenium; for oral use in medicines containing 300 micrograms or less and more than 150 micrograms per recommended daily dose; for external use except in medicines containing 3.5% or less of selenium sulphide 156 Sennosides 157 Silver; except in oral solutions containing 0.3% or less or other medicines con‐ taining 1% or less 158 Silver sulfadiazine; for external use in pack sizes of 50 grams or less 159 Sodium cromoglycate; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board 160 Sodium nitrite; except for use as an excipient 161 Sodium picosulphate; in oral laxative preparations 162 Squill; except in medicines containing 1% or less 163 Stramonium; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per rec‐ ommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids 164 Sulconazole; for dermal use 165 Sulfadiazine, silver; for external use in pack sizes of 50 grams or less 166
 Terbinafine; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board 167 Tetrachloroethylene 168 Tetrahydrozoline; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board 169 Thiabendazole 170 Tioconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board 171 Tramazoline 151 Schedule
 1 Medicines Regulations 1984 Version as at 16 June 2023 172 Triamcinolone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age and when in aqueous nasal sprays delivering up to 55 micrograms per actuation when the maximum recommended daily dose is no greater than 220 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine 173 Trimeprazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack contain‐ ing trimeprazine or when at least 1 of the other therapeutically active ingredi‐ ents is a sympathomimetic decongestant 174 Triprolidine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack contain‐ ing triprolidine or when at least 1 of the other active ingredients is a sympatho‐ mimetic decongestant 175 Tuaminoheptane 176 Tymazoline 177 Xylenols; except in medicines containing 3% or less 178 Xylometazoline; except for nasal use when sold at an airport; except for oph‐ thalmic use when sold in practice by an optometrist registered with the Optom‐ etrists and Dispensing Opticians Board 179 Zinc chloride; for dermal use in
 medicines containing more than 5% 152 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Schedule 2 Form 1 Application for licence to manufacture, hawk, sell, or pack medicine [Before completing this form you should make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, especially those parts that deal with licences.
This form may be used to apply for licences to manufacture, pack, sell, or hawk medi‐ cines.

It is divided into 7 parts.

Every applicant must complete either Part 1 or Part 2, and must also complete at least one of Parts 3, 4, 5, 6, and 7.

Every application must be accompanied by the prescribed fee for each licence applied for (viz, regulation 61, Medicines Regulations 1984).]

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.]

Part 1 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 If yes give details: 153 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Have you ever been declined, or had revoked, a licence to manufacture, 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.]
Part 2 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 Medicines Act 1981: Name 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 responsible person under the Restricted Drugs Act 1960 or the Medicines Act 1981?

Yes/No 154 Version as at 16 June 2023 If yes give details: Medicines Regulations 1984 Schedule 2 Part 3 Application to manufacture medicines I hereby make application for a licence to manufacture the medicines listed below (attach extra list if insufficient space provided here).
Indicate (by reference to one of the following paragraphs) which of the following classes the medicines come within: (a) (b) (c) (d) (e) (f) antibiotics, or preparations of antibiotics: vaccines and sera: sterile preparations: hormones and steroid preparations: preparations, other than vitamins, having a dose of 5 milligrams or less per unit dose: antineoplastic agents and immunosuppressant agents other than steroid prepar‐ ations: (g) other medicines not included in paragraphs (a) to (f), above.
Appropriate designation Trade name of medicine Class Premises where manufacture (including packing and labelling) of the medicines will be carried out: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a body corporate): Date: 155 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Part 4 Application to pack medicines I hereby make application for a licence to pack the medicines listed below (attach extra list if insufficient space provided here).
Indicate in the third column whether the medicine is a prescription medicine, restricted medicine, or pharmacy-only medicine.
Appropriate designation Trade name of medicine Class Premises where packing and labelling will be carried out: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a body corporate): Date: Part 5 Application to sell medicines by wholesale I hereby make application to sell by wholesale the following medicines (attach extra list if insufficient space provided here): Premises from where medicines are to be sold: I enclose the fee of: 156 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Signature of applicant (or Common Seal where applicant is a body corporate): Date: Part 6 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 road from the nearest pharmacy.
The reasons for this application are: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a body corporate): Date: Part 7 Application to hawk medicines I hereby make application for a licence to hawk medicines.
Premises where stock of medicines will be kept: 157 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 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 hawk medicines: Name and maximum quantity of medicines intended to be transported when hawking: I enclose the fee of: Signature of applicant (or Common Seal where applicant is a body corporate): Date: Schedule 2 form 1 heading: substituted, on 18 September 2004, by regulation 9(1)(a) of the Medi‐ cines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1 Part 1: amended, on 18 September 2004, by regulation 9(1)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1 Part 2: amended, on 18 September 2004, by regulation 9(1)(c) of the Medicines Amendment Regulations 2004 (SR 2004/300).
158 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Form 1A Application for licence to operate pharmacy made (by employee or agent) on behalf of company r 45A(1)(a)(i) 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 making an application on behalf of a company: you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies: 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 additional information at a later date (see section 55B of the Medicines Act 1981).
If you do not supply that information within 30 days 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 company], make this application for a licence to operate a pharmacy on behalf of [name of company], which— (a) (b) 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 for the purposes of the licence under the Medicines Act 1981: [full names, dates of birth, and positions held].

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 draw‐ ing showing the part or parts].

159 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Interests held in pharmacy Note: Before filling out this part of the form please read section 5A 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 section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particu‐ lars of the interest held (or “none” if applicable)].
The following person(s) who hold an interest in the pharmacy to which this applica‐ ton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designa‐ ted prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none” if applicable)].
Eligibility to hold licence *The share capital of the company is more than 50% owned by [full name of pharma‐ cist] who is a pharmacist† (or [full names of pharmacists] who are pharmacists) and effective control of the company is vested in the above-named pharmacist (or pharmacists).
†In this context, a pharmacist— means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy; and includes an administrator of the estate of a deceased pharmacist, and an assignee within the meaning of the Insolvency Act 1967 of the estate of a pharmacist, until— (i) (ii) the expiry of the period of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt; or or subject to any conditions that the licensing authority proposes, the extended period or periods permitted by the licensing authority.
(a) (b) 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 section 55D(2) 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 pharma‐ cist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applic‐ able professional or ethical standards of the pharmacy practice: [specify relevant practices and procedures].
160 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 *In this context, a pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

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 section 4 of the Property Law Act 2007.
Signature of applicant: Declaration I, [full name of agent or employee of the company], 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 Oaths and Declarations Act 1957.
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 regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1A: amended, on 1 January 2008, by regulation 4 of the Medicines (Property Law Act 2007) Amendment Regulations 2007 (SR 2007/382).
161 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Form 1B Application for licence to operate pharmacy made by person who is individual (or employee or agent of body corporate that is not company) r 45A(1)(a)(ii) 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 a pharmacy; or an employee or agent of a body corporate (other than a company) who is applying for a licence to operate a pharmacy on behalf of that body cor‐ porate (for example, an application made on behalf of a partnership or friendly society): you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies: 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 additional information at a later date (see section 55B of the Medicines Act 1981).
If you do not supply that information within 30 days 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 (b) was incorporated in New Zealand on [date]; and (c) 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 162 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 *I hold the office of [specify office held] within the above-named body corporate.

The following persons are nominated to be responsible persons under the Medicines Act 1981: [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 draw‐ ing showing the part or parts].

Interests held in pharmacy Note: Before filling out this part of the form please read section 5A 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 section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particu‐ lars of the interest held (or “none” if applicable)].
The following person(s) who hold an interest in the pharmacy to which this applica‐ ton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designa‐ ted prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none” if applicable)].
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 estab‐ lished by the Health Practitioners Competence Assurance Act 2003 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 section 55E(3) 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.]
[Specify details.]

or 163 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 *I am (or The body corporate is) eligible to operate a pharmacy because [specify other ground in section 55E(1) of the Medicines Act 1981 that makes person or body corporate eligible to hold a licence].

*Delete if inapplicable.


Practices and procedure for pharmacists working in pharmacy The following practices and procedures will be in place to ensure that any pharma‐ cist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applic‐ able 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 the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

Other pharmacies I operate (or have a majority interest in) (or The body corporate operates) the follow‐ ing pharmacy (or pharmacies): [name(s) and address(es) of the pharmacy (or phar‐ macies) (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 section 4 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 Oaths and Declarations Act 1957.
164 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 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 regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1B: amended, on 1 August 2011, by regulation 28 of the Medicines Amendment Regulations 2011 (SR 2011/245).
165 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Form 2 Licence to manufacture medicines (Issued pursuant to the Medicines Act 1981) Licence No: Name of licensee: Address of licensee: Name of responsible persons: The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to manufacture, pack, label, and sell by wholesale the following medicines or classes of medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the following conditions: (1) The manufacture, packing, labelling, or sale of the medicines shall be carried out in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2) [Further conditions imposed by the licensing authority]: This licence shall expire on [date].

[Signature] (Licensing authority) Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(a) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).
Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(b) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).
166 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Form 3 Licence to hawk medicines (Issued pursuant to the Medicines Act 1981) Licence No: Name of licensee: Address of licensee: Names of responsible persons: The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to hawk the following medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the following conditions: (1) All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.
(2) (3) (4) (5) (6) The stock of medicines held by the licensee or responsible person 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 geographical area: Sales shall only be made to the following persons or classes of persons: [Further conditions imposed by the licensing authority]: This licence shall expire on [date].
[Signature] (Licensing authority) 167 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).

Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).
168 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Form 4 Licence to sell medicines by wholesale (Issued pursuant to the Medicines Act 1981) 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 hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by wholesale the following medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the following conditions: (1) The sale of the above medicines shall not take place other than at the business premises set out above.

(2) All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(3) [Further conditions imposed by the licensing authority]: This licence shall expire on [date].
[Signature] (Licensing authority) 169 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).

Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).
170 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Form 5 Licence to sell medicines by retail (Issued pursuant to the Medicines Act 1981) 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 hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by 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 following conditions: (1) The sale of the above medicines shall not take place other than at the business premises set out above.

(2) All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(3) [Further conditions imposed by the licensing authority]: This licence shall expire on [date].
[Signature] (Licensing authority) 171 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).

Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).
172 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Form 6 Licence to pack medicines (Issued pursuant to the Medicines Act 1981) 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 hereby authorised pursuant to section 51 of the Medicines Act 1981 to pack or label for the purpose of sale, and sell by wholesale the following medicines: *Delete whichever does not apply.
The authority granted by this licence is subject to the following conditions: (1) The packing, labelling, or sale of the medicines shall be carried out in accord‐ ance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2) [Further conditions imposed by the licensing authority]: This licence shall expire on [date].
[Signature] (Licensing authority) 173 Schedule 2 Medicines Regulations 1984 Version as at 16 June 2023 Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).

Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amend‐ ment Regulations 2004 (SR 2004/300).
174 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 2 Form 7 Licence to operate pharmacy Section 51, Medicines Act 1981 r 46(1)(f) Licence No: This licence to operate a pharmacy is granted to [full name of person or body corpo‐ rate] of [address] and authorises— • • the establishment of a pharmacy at [location] (or in the following 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 and obligations in the Medicines Act 1981.
This licence is subject to the following conditions: (a) the holder of this licence must not request or require any pharmacist who is employed or engaged in duties at the above-named pharmacy to act in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice: (b) [specify any other conditions].

This licence expires on [date].


[Signature] (Licensing authority) Schedule 2 form 7: added, on 18 September 2004, by regulation 11 of the Medicines Amendment Regulations 2004 (SR 2004/300).

175 Schedule 3 Medicines Regulations 1984 Schedule 3 Loose sheet data sheet requirements [Revoked] Version as at 16 June 2023 r 53(2) Schedule 3: revoked, on 1 August 2011, by regulation 29 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Schedule 4 Hawker’s Medicines book Name of medicine Form Strength Page r 56(2)(a) Name and address of supplier of medicine or Name and address of person to whom medicine sold Date Order No In Out Balance 176 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 5 Schedule 5 Analyst’s certificate under the Medicines Act 1981 r 60 I, [name], an analyst under the Medicines Act 1981, certify that on [date] there was submitted to me by [name and address of the officer from whom the sample was received] an officer within the meaning of that Act, a sample of [name or description of sample] for analysis in a [nature of the package in which the sample was enclosed, and how it was labelled, marked, and sealed] and that the same has been analysed and that the result of the analysis is as follows [analysis and observations]: Date: [Signature] Analyst 177 Schedule 5A Medicines Regulations 1984 Version as at 16 June 2023 Schedule 5A Licence fees Schedule 5A: inserted, on 21 August 2006, by regulation 6 of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
rr 45A(1)(b)(i), 61(1) An application for a licence to manufacture medicines An application for a licence to pack medicines 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 medicines An application for a combined licence to pack, and to sell by retail, medicines An application for a licence to operate a pharmacy $ 14,328 880 880 1,123 880 313 1,097 Schedule 5A: amended, on 1 July 2022, by regulation 8 of the Medicines Amendment Regulations 2022 (SL 2022/116).
178 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 6 Schedule 6 Regulations revoked Part A Restricted drugs 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) 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) r 62 179 Schedule 6 Medicines Regulations 1984 Version as at 16 June
 2023 Restricted Drugs Regulations 1964, Amendment No 21 (SR 1984/78) Part B Restricted drugs licences Restricted Drug Licences Regulations 1961 (SR 1961/39) Restricted Drug Licences Regulations 1961, Amendment No 1 (SR 1963/123) Restricted Drug Licences Regulations 1961, Amendment No 2 (SR 1983/133) Part C 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) Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 10 (SR 1983/147) 180 Version as at 16 June 2023 Medicines Regulations 1984 Schedule 6 Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 11 (SR 1983/205) Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 12 (SR 1984/41) Issued under the authority of the Legislation Act 2019.
Date of notification in Gazette: 7 June 1984.

P G Millen, Clerk of the Executive Council.

181 Medicines Regulations 1984 Version as at 16 June 2023 Notes Notes 1 General This is a consolidation of the Medicines Regulations 1984 that incorporates the amendments made to the legislation so that it shows the law as at its stated date.

2 Legal status A consolidation is taken to correctly state, as at its stated date, the law enacted or made by the legislation consolidated and by the amendments.
This presump‐ tion applies unless the contrary is shown.

Section 78 of the Legislation Act 2019 provides that this consolidation, pub‐ lished as an electronic version, is an official version.

A printed version of legis‐ lation that is produced directly from this official electronic version is also an official version.
3 Editorial and format changes The Parliamentary Counsel Office makes editorial and format changes to con‐ solidations using the powers under subpart 2 of Part 3 of the Legislation Act 2019.

See also PCO editorial conventions for consolidations.
4 Amendments incorporated in this consolidation Medicines Amendment Regulations 2023 (SL 2023/130) Medicines Amendment Regulations (No 2) 2022 (SL 2022/304) Pae Ora (Healthy Futures) Act 2022 (2022 No 30): section 104 Medicines Amendment Regulations 2022 (SL 2022/116) Water Services Act 2021 (2021 No 36): section 206(2) Medicines (Assisted Dying Medications) Amendment Regulations 2021 (LI 2021/266) Medicines Amendment Regulations (No 2) 2021 (LI 2021/228) Medicines Amendment Regulations 2021 (LI 2021/44) Medicines Amendment Regulations 2020 (LI 2020/262) Smokefree Environments and Regulated Products (Vaping) Amendment Act 2020 (2020 No 62): sec‐ tion 30 Abortion Legislation Act 2020 (2020 No 6): section 18(2) Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (LI 2019/321): regulations 84, 85 Medicines Amendment Regulations 2015 (LI 2015/7) Medicines Amendment Regulations 2014 (LI 2014/165) Medicines Amendment Regulations 2012 (SR 2012/329) Criminal Procedure Act 2011 (2011 No 81): section 413 Medicines Amendment Regulations 2011 (SR 2011/245) Medicines (Property Law Act 2007) Amendment Regulations 2007 (SR 2007/382) Medicines (Fees) Amendment Regulations 2006 (SR 2006/188) 182 Version as at 16 June 2023 Medicines Regulations 1984 Notes Medicines Amendment Regulations 2006 (SR 2006/158) Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR 2005/266): regulation 12(2)(a) Medicines Amendment Regulations 2005 (SR 2005/255) Medicines Amendment Regulations 2004 (SR 2004/300) Health
 Practitioners Competence Assurance Act 2003 (2003 No 48): section 175(3) Medicines Amendment Regulations (No 2) 2002 (SR 2002/374) Health and Disability Services (Safety) Act 2001 (2001 No 93): section 58(3) Medicines Amendment Regulations 2001 (SR 2001/232) Medicines Amendment Regulations 2000 (SR 2000/220) Medicines Amendment Regulations 1997 (SR 1997/165) Medicines Regulations 1984, Amendment No 6 (SR 1994/299) Medicines Regulations 1984, Amendment No 5 (SR 1992/43) Medicines Regulations 1984, Amendment No 4 (SR 1991/134) Medicines Regulations 1984 (SR 1984/143): regulation 44AB(5) Wellington, New Zealand: Published under the authority of the New Zealand Government—2023 183