Pursuant to sections 62 and 105 of the Medicines Act 1981, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations or bodies appearing to the Minister to be representative of persons likely to be substantially affected, and acting on the advice and with the consent of the Executive Council, makes the following regulations.

1 Title

2 Commencement

3 Principal regulations amended

4 Interpretation

5 Regulation 6 revoked

6 New regulation 8 substituted

8 Advertisements for medicines

7 Regulation 11 substituted

11 Advertisements intended for health professions

8 New regulations 13 to 16 substituted

13 Labelling of medicines

14 Labelling of related products

15 Exemptions from regulations 13 and 14

16 Principal display panel

9 Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines

10 Regulation 20 revoked

11 New regulation 22 substituted

22 Warning statements for medicines and related products

12 Labels on containers of medicines sold by authorised prescribers or pharmacists

13 Safety containers

14 New regulation 39 substituted

39 Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines

15 New regulation 39A inserted

39A Limit on period of supply of prescription medicines

16 Prescriptions to comply with regulations

17 Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing

18 Form of prescription

19 Dispensing of prescription medicines

20 New regulation 43 substituted

43 Director-General may waive certain requirements

21 Prescriptions for prescription medicines not required in certain cases

22 New regulations 51 to 53 substituted

51 Interpretation

52 Approval of data sheets for new medicines

53 Approval of data sheets for changed medicines

23 New regulation 58A inserted

58A Substances that are not medicines or related products for purposes of Act

24 New regulation 59 substituted

59 General sale medicines may be sold by vending machine

25 Offences

26 New regulation 65A inserted

65A Transitional provision arising from enactment of Medicines Amendment Regulations 2011

27 New Schedule 1 substituted

28 Form 1B of Schedule 2 amended

29 Schedule 3 revoked

30 Amendments to Misuse of Drugs Regulations 1977

Schedule
New Schedule 1 substituted

Regulations

1 Title

These regulations are the Medicines Amendment Regulations 2011.

2 Commencement

(1) These regulations, except regulations 14, 15, and 18, come into force on 1 August 2011.

(2) Regulations 14, 15, and 18 come into force on 1 December 2011.

3 Principal regulations amended

These regulations amend the Medicines Regulations 1984.

4 Interpretation

(1) Regulation 2(1) is amended by revoking the definitions of approved school, colouring substance, and Dispensary Assistant's Certificate.
(2) Regulation 2(1) is amended by revoking the definition of dispensary technician and substituting the following definition:
“dispensary technician means a person who holds a certificate issued by the Pharmaceutical Society of New Zealand before 18 September 2004 that—

“(a) classifies the holder as a dispensary assistant; or

“(b) records that the person has completed the requirements of the Pharmacy Technicians Certificate”.
(3) Regulation 2(1) is amended by inserting the following definition in its appropriate alphabetical order:

“general sale medicine has the meaning given to it by section 99(2) of the Act”.

(4) Regulation 2(1) is amended by inserting the following definition in its appropriate alphabetical order:

“Pharmacy Council means the Pharmacy Council established by section 114(5) of the Health Practitioners Competence Assurance Act 2003”.
(5) Regulation 2(1) is amended by revoking the definitions of pharmacy graduate, pharmacy student, and pharmacy technician and substituting the following definitions in their appropriate alphabetical order:
“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 completed, the course and examinations leading to a qualification of a kind prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Competence Assurance Act 2003

“pharmacy technician means any person who has a National Certificate in Pharmacy (Technician)”.

5 Regulation 6 revoked

Regulation 6 is revoked.

6 New regulation 8 substituted

Regulation 8 is revoked and the following regulation substituted:
“8 Advertisements for medicines

“(1) Every advertisement for a prescription medicine must include—

“(a) the words ‘Prescription medicine’ or words of a similar meaning; and

“(b) the name of each active ingredient; and

“(c) the appropriate quantitative particulars of each active ingredient; and

“(d) a statement of the purpose for which the medicine is intended to be used; and

“(e) a statement that the medicine has risks and benefits; and

“(f) a statement about how to find further information on the risks and benefits of the medicine.

“(2) Every advertisement for a restricted medicine must include—

“(a) the following statements, or statements with a similar meaning:

“(i) ‘Available only from your pharmacist.’; and

“(ii) ‘If symptoms persist, see your doctor or health professional.’; and

“(iii) ‘Use only as directed.’; and

“(b) the name of each active ingredient, or the following statement, or a statement with a similar meaning:

‘Always read the label.’; and

“(c) a statement of the purpose for which the medicine is intended to be used; and

“(d) any warning statement that may be required by guidelines issued from time to time by the Ministry of Health.

“(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) ‘If symptoms persist, see your doctor or health professional.’; and

“(ii) ‘Use only as directed.’; and

“(b) the name of each active ingredient, or the following statement, or a statement with a similar meaning:

‘Always read the label.’; and

“(c) a statement of the purpose for which the medicine is intended to be used; and

“(d) 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 marketing, or via the Internet must—

“(a) include the name of each active ingredient; and

“(b) include the appropriate quantitative particulars of each active ingredient; and

“(c) comply with the following, to the extent they are applicable:

“(i) subclause (1)(a), and (d) to (f):

“(ii) subclause (2)(a), (c), and (d):

“(iii) subclause (3)(a), (c), and (d).

“(5) A statement required by this regulation must be—

“(a) clearly printed; or

“(b) 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) an advertisement for a medicine that does not refer to a therapeutic purpose:

“(b) an advertisement (not being an advertisement of the kind described in subclause (4)) that is—

“(i) located at the point of sale; and

“(ii) positioned immediately above, below, or next to the medicine to which it relates:

“(c) labels:

“(d) 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) the advertisement was compliant with every applicable requirement in this regulation immediately before the medicine was reclassified; and

“(b) not more than 3 months have elapsed since the medicine was reclassified.

“(9) In any proceedings for an offence against section 57 of the Act, it is for the defendant to prove that subclause (8) applies.”

7 Regulation 11 substituted

Regulation 11 is revoked and the following regulation substituted:
“11 Advertisements intended for health professions

“(1) This regulation applies—

“(a) to advertisements intended for members of the medical, dental, pharmaceutical, and related professions; and

“(b) in addition to the requirements in regulations 7, 9, and 10 (but not regulation 8).

“(2) Every advertisement for a medicine must—

“(a) include—

“(i) the classification of the medicine; and

“(ii) the name of each active ingredient; and

“(iii) the appropriate quantitative particulars of each active ingredient; and

“(iv) a statement of the purpose for which the medicine is intended to be used; and

“(v) a statement of the appropriate precautions to be taken in the use of the medicine; and

“(vi) information on the effectiveness and limitations of the medicine; and

“(vii) a statement of any restriction imposed on distribution; and

“(viii) the dosage regime and mode of administration, or method of use, of the medicine; and

“(ix) a statement of any contraindications to the use of the medicine; and

“(x) information on the likely potentiating effects and interactions with other substances, medicines, or environmental influences; and

“(xi) a statement of the known or likely poisonous effects of, or adverse reactions to, the medicine; but

“(b) not include—

“(i) 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

“(ii) an unsubstantiated comparison with other medicines; or

“(iii) data, previously considered valid, but made obsolete or false by subsequent findings; or

“(iv) a statement of the use of the medicine, or the dosage of the medicine, that contravenes any condition of a consent given under section 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) a major therapeutic indication of a medicine; or

“(ii) the listing of a medicine in the pharmaceutical schedule (within the meaning of section 6(1) of the New Zealand Public Health and Disability Act 2000); 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) a statement of any restriction imposed on distribution; and

“(b) the dosage regime and mode of administration, or method of use, of the related product or medical device; and

“(c) information on the effectiveness and limitations of the related product or medical device.”

8 New regulations 13 to 16 substituted

Regulations 13 to 16 are revoked and the following regulations substituted:
“13 Labelling of medicines

“(1) Every container of a medicine must, unless otherwise provided by these regulations, bear a label containing the following information:

“(a) the trade name of the medicine or, if there is no trade name, the appropriate designation of the medicine:

“(b) the name of each active ingredient:

“(c) the appropriate quantitative particulars of each active ingredient:

“(d) a description of the medicine, including dose form, or presentation, that indicates the true nature of the medicine:

“(e) 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,—

“(i) the words ‘PRESCRIPTION MEDICINE’ or words of a similar meaning; or

“(ii) 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) the words ‘RESTRICTED MEDICINE’; or

“(ii) the words ‘PHARMACIST-ONLY MEDICINE’:

“(h) in the case of a pharmacy-only medicine,—

“(i) the words ‘PHARMACY-ONLY MEDICINE’ or words of a similar meaning; or

“(ii) the words ‘PHARMACY MEDICINE’ or words of a similar meaning:

“(i) any warning statement required by these regulations for the medicine:

“(j) 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:

“(k) in the case of a medicine sold, or intended for sale, for external use,—

“(i) a statement of directions for use and frequency of use; and

“(ii) 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) the dose recommended; and

“(ii) the frequency of that dose:

“(m) 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:

“(n) the words ‘Use by’ or ‘Use before’, or words of a similar meaning, followed 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) the manufacturer or seller of the medicine; or

“(ii) 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:

“(b) 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:

“(c) 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 sufficient.

“(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 specific 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) is sold by retail; or

“(b) is supplied in circumstances corresponding to retail sale; or

“(c) is supplied by way of gift or sample for the purpose of promoting a sale.

“(5) Subclause (1)(l) does not apply in the case of a medicine intended to be administered by or under the supervision of a practitioner, in circumstances where the dosage is to be dependent on concurrent skilled observation.

“(6) 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.

“(7) Every container of a medicine that is a biochemical preparation must, in addition to the other requirements in this regulation, bear a label containing the following:

“(a) a statement of the potency of the preparation; and

“(b) 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.
“14 Labelling of related products

“(1) Every container of a related product must, unless otherwise provided by these regulations, bear a label containing the following information:

“(a) the trade name of the related product or, if there is no trade name, the appropriate designation of the related product:

“(b) the name of each active ingredient:

“(c) the appropriate quantitative particulars of each active ingredient:

“(d) a description of the related product that indicates the true nature of the related product:

“(e) a statement of the net weight or volume or number of the contents of the container, as the case may require:

“(f) any warning statement required by these regulations for the related product:

“(g) in the case of a related product sold, or intended for sale, for external use,—

“(i) a statement of directions for use and frequency of use; and

“(ii) 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) the dose recommended; and

“(ii) the frequency of that dose:

“(i) 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:

“(j) where appropriate, an expiry date:

“(k) the name and address of—

“(i) the manufacturer or seller of the related product; or

“(ii) 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) an address at a post office is not sufficient:

“(b) 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:

“(c) 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 sufficient.
“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) contains a single dose of a medicine or related product; and

“(ii) is made of sheet material; and

“(iii) is not attached to another container; and

“(iv) 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) contains a single dose of a medicine or related product; and

“(ii) is not made of sheet material; and

“(iii) has a volume of 20 millilitres or less; and

“(iv) 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) contains a medicine or related product that is a gas; and

“(ii) 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) is made of sheet material; and

“(b) bears the information required by—

“(i) regulation 13(1)(m) and (n) or regulation 14(1)(i) and (j) (as the case requires) at least once on the strip; and

“(ii) 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 containers 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.

“(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 manufacturer 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) 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 Zealand are deemed to be part of the purchaser's stock-in-trade in New Zealand.

“(7) 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.
“16 Principal display panel

“(1) The principal display panel of the label of a medicine must contain—

“(a) the information required by regulation 13(1)(a), (d), and (e); and

“(b) the information required by regulation 13(1)(b) and (c), but only if the medicine contains 3 or fewer active ingredients.

“(2) Subclause (1) is subject to regulation 23.

“(3) The principal display panel of the label of a related product must contain—

“(a) the information required by regulation 14(1)(a), (d), and (e); and

“(b) 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.”

9 Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines

Regulation 19 is amended by omitting “Subject to regulation 37(3) of these regulations, where” and substituting “Where”.

10 Regulation 20 revoked

Regulation 20 is revoked.

11 New regulation 22 substituted

Regulation 22 is revoked and the following regulation substituted:
“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.”

12 Labels on containers of medicines sold by authorised prescribers or pharmacists

(1) Regulation 23 is amended by omitting “regulation 15(1)” and substituting “regulation 16(1)”.
(2) Regulation 23 is amended by revoking paragraph (a) and substituting the following paragraph:
- “(a) the name of, or a description of the nature of, the contents; and”.
(3) Regulation 23 is amended by adding “; and” and also by adding the following paragraphs:
- “(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.”

13 Safety containers

Regulation 37(3) is revoked.

14 New regulation 39 substituted

Regulation 39 is revoked and the following regulation substituted:
“39 Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines

“(1) An authorised prescriber (including a designated prescriber) may only prescribe 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 prescribing 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) the prescription medicine is of a class or description that the designated prescriber is authorised to prescribe by regulations made under the Act; and

“(b) the requirements specified in or imposed under those regulations are satisfied.

“(3) A veterinarian may only prescribe a prescription medicine that is for the treatment 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.”

15 New regulation 39A inserted

The following regulation is inserted after regulation 39:
“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) 6 months' supply in the case of an oral contraceptive; or

“(b) 3 months' supply in any other case.

“(2) However, the Director-General may, at his or her discretion, authorise—

“(a) an authorised prescriber to prescribe for any patient, or any specified class or classes of patients, a quantity of a prescription medicine exceeding the period of supply in subclause (1)(a) or (b):

“(b) a class of authorised prescribers to prescribe for any patient, or any specified class or classes of patients, a quantity of a prescription medicine exceeding the period of supply in subclause (1)(a) or (b).”

16 Prescriptions to comply with regulations

Regulation 40(1) is amended by omitting “veterinary surgeon” and substituting “veterinarian”.

17 Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing

Regulation 40A is amended by omitting “veterinary surgeon” in each place where it appears and substituting in each case “veterinarian”.

18 Form of prescription

(1) Regulation 41 is amended by revoking paragraph (c) and substituting the following paragraph:
- “(c) set out the following information in relation to the prescriber:
  
  “(i) the prescriber's full name; and
  
  “(ii) 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”.
(2) Regulation 41(d) is amended by revoking subparagraph (i) and substituting the following subparagraph:
- “(i) the surname, each given name, and the address of the person for whose use the prescription is given; and”.
(3) Regulation 41 is amended by revoking paragraph (f) and substituting the following paragraph:
- “(f) indicate the total amount of medicine that may be sold or dispensed, or the total period of supply; and”.
(4) Regulation 41 is amended by revoking paragraph (i).
(5) Regulation 41(j) is amended by revoking subparagraph (i) and substituting the following subparagraph:
- “(i) set out the surname, each given name, and the address of the owner of the animal; and”.

19 Dispensing of prescription medicines

(1) Regulation 42 is amended by omitting “veterinary surgeon” in each place where it appears and substituting in each case “veterinarian”.
(2) Regulation 42 is amended by revoking subclauses (3) and (4) and substituting the following subclauses:
- “(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 written confirmation of the prescription, as required by regulation 40A(2):
  
  “(b) the following information must be recorded on the prescription:
  
  “(i) the name and address of the proprietor of the business at which the prescription is dispensed; and
  
  “(ii) the date on which the prescription is dispensed; and
  
  “(iii) the quantity of medicine dispensed; and
  
  “(iv) a unique identifying number or code for the prescription:
  
  “(c) 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 it was printed or, if given under regulation 40A(1), communicated orally:
  
  “(d) 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 it was printed or, if given under regulation 40A(1), communicated orally:
  
  “(e) every 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 inspection.
- “(4) If an authorised prescriber or a veterinarian refers in a prescription to a medicine by its trade mark or trade name, or by reference to the name of its manufacturer, 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
  
  “(b) the substituted brand contains the same active ingredient or active ingredients, and no other active ingredients; and
  
  “(c) the substituted brand is in the same dose form and strength as the prescribed brand; and
  
  “(d) there is no clinical reason why the substituted brand should not be supplied; and
  
  “(e) the pharmacist records the brand substitution on the prescription; and
  
  “(f) the pharmacist signs and dates the prescription; and
  
  “(g) the pharmacist informs the patient of the brand substitution.
- “(5) This regulation is subject to regulation 43.”

20 New regulation 43 substituted

Regulation 43 is revoked and the following regulation substituted:
“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,—

“(a) 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 requirements that he or she thinks fit; and

“(b) 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.”

21 Prescriptions for prescription medicines not required in certain cases

(1) Regulation 44(f) is amended by omitting “veterinary surgeon” and substituting “veterinarian”.
(2) Regulation 44 is amended by revoking paragraph (h) and substituting the following paragraph:
- “(h) a patient under the care of an authorised prescriber, provided that—
  
  “(i) the medicine is administered by a person who has been instructed by the authorised prescriber (either verbally or in writing) to do so; and
  
  “(ii) the person administering the medicine records the administration in the patient's medical record; and
  
  “(iii) the authorised prescriber records the instruction under subparagraph (i) in the patient's medical record; or”.
(3) Regulation 44(m) is amended by omitting “(except a dentist)”.

(4) Regulation 44(n) is amended by omitting “veterinary surgeon” in each place where it appears and substituting in each case “veterinarian”.

22 New regulations 51 to 53 substituted

Regulations 51 to 54 are revoked and the following regulations substituted:
“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.
“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) approve the data sheet; or

“(b) 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.
“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) approve the revised data sheet; or

“(b) require the revised data sheet to be resubmitted for approval after such changes have been made to it as the Director-General considers appropriate.

“(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 manufacturer.

“(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.”

23 New regulation 58A inserted

The following regulation is inserted above regulation 59:
“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) the dentifrice product does not contain a medicine specified in Schedule 1; and

“(ii) the dentifrice product is not claimed to be for use in relation to any therapeutic purpose other than 1 or both of the following:

“(A) preventing dental decay:

“(B) improving oral hygiene:

“(b) anti-dandruff hair products, provided that—

“(i) the hair product does not contain a medicine specified in Schedule 1; and

“(ii) the hair product is not claimed to be for use in relation to any therapeutic purpose except controlling dandruff; and

“(iii) 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) the skin care product does not contain a medicine specified in Schedule 1; and

“(ii) the skin care product is not claimed to be for use in relation to any therapeutic purpose except preventing acne; and

“(iii) 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) the barrier cream product does not contain a medicine specified in Schedule 1; and

“(ii) the barrier cream product is not claimed to be for use in relation to any therapeutic purpose except preventing nappy rash; and

“(iii) the barrier cream product is claimed to be effective through providing a barrier to the transmission of moisture and not through any other process:

“(e) anti-bacterial skin products, provided that—

“(i) the product does not contain a medicine specified in Schedule 1; and

“(ii) the product is not claimed to be for use in relation to any therapeutic 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) piercing the skin or mucous membrane for any purpose; and

“(b) venipuncture, or the delivery of an injection.”

24 New regulation 59 substituted

Regulation 59 is revoked and the following regulation substituted:
“59 General sale medicines may be sold by vending machine

“(1) The Director-General may, by notice in the Gazette,—

“(a) approve the sale of a general sale medicine by means of a vending machine:

“(b) specify any conditions to which an approval under paragraph (a) is subject:

“(c) withdraw an approval given under paragraph (a):

“(d) vary or revoke any conditions specified under paragraph (b), or specify additional conditions, to which an approval under paragraph (a) is subject.

“(2) A notice given under subclause (1) takes effect on the day after the date of notification.”

25 Offences

(1) Regulation 64(1)(a) is amended by omitting “39(1), 39(2), 39(3), 39(4), 39(5), 39(7), 39(8)” and substituting “39, 39A(1)”.

(2) Regulation 64(1)(c) is amended by omitting “52(1), 52(2), 52(5)” and substituting “52(3), 53(4)”.

26 New regulation 65A inserted

The following regulation is inserted after regulation 65:
“65A Transitional provision arising from enactment of Medicines Amendment Regulations 2011

“(1) Until 1 February 2012, it is sufficient compliance with the advertising requirements of regulations 8 and 11 to comply with regulations 8 and 11 as in force immediately before 1 August 2011.

“(2) For medicines and related products manufactured or imported before 1 September 2012, it is sufficient compliance with the labelling requirements of regulations 13 to 16, 19, 22, 23, and 37 to comply with regulations 13 to 16, 19, 20, 22, 23, and 37 as in force immediately before 1 August 2011.”

27 New Schedule 1 substituted

Schedule 1 is revoked and the Schedule 1 set out in the Schedule of these regulations substituted.

28 Form 1B of Schedule 2 amended

Form 1B of Schedule 2 is amended by omitting “section 2 of the Property Law Act 1952” and substituting “section 4 of the Property Law Act 2007”.

29 Schedule 3 revoked

Schedule 3 is revoked.

30 Amendments to Misuse of Drugs Regulations 1977

(1) This regulation amends the Misuse of Drugs Regulations 1977.

(2) Regulation 25(3)(a)(i) is amended by omitting “regulations 13(1)(a) and 16(1)(ab)” and substituting “regulation 15(2)”.
(3) Regulation 25(3)(b) is amended by revoking subparagraph (ii) and substituting the following subparagraph:
- “(ii) the labelling of the safety container complies with the Medicines Regulations 1984.”

r 27

Schedule 1
Prescription, restricted, and pharmacy-only medicines

r 3

Every reference to a medicine in this schedule applies whether the medicine is synthetic 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.

1 19-norandrostenedione

2 2,4-dinitrochlorobenzene

3 4-aminopyridine

4 4-chloromethandienone

5 4-chlorotestosterone

6 Abacavir

7 Abatacept

8 Abciximab

9 Abrus precatorius; at all strengths

10 Acamprosate

11 Acarbose

12 Acebutolol

13 Acepromazine

14 Acetanilides

15 Acetarsol

16 Acetazolamide

17 Acetohexamide

18 Acetylcarbromal

19 Acetylcholine; except in medicines containing 1 milligram or less per litre or per kilogram

20 Acetylcysteine; for injection or inhalation

21 Acetyldigitoxin

22 Acetylmethyldimethyloximidophenylhydrazine

23 Acetylstrophanthidin

24 Aciclovir; except for external use for the treatment of herpes labialis

25 Acipimox

26 Acitretin

27 Acokanthera ouabaio

28 Acokanthera schimperi

29 Aconitum spp.; except when specified elsewhere in this schedule

30 Acrivastine

31 Adalimumab

32 Adapalene

33 Adefovir

34 Adenosine; for injection

35 Adinazolam

36 Adiphenine

37 Adonis vernalis

38 Adrafinil

39 Adrenal extract; except for dermal use in medicines containing 0.02% or less of ketosteroids

40 Adrenaline; in medicines containing more than 1%

41 Adrenocortical hormones; except adrenal extract for dermal use containing 0.02% or less of ketosteroids

42 Agalsidase

43 Agomelatine

44 Alatrofloxacin

45 Albendazole

46 Albumin; except human albumin

47 Alclofenac

48 Alclometasone; except when specified elsewhere in this schedule

49 Alcohol; for injection in medicines containing more than 20%

50 Alcuronium

51 Aldesleukin

52 Aldosterone; except in medicines containing 10 micrograms or less per litre or per kilogram

53 Alefacept

54 Alemtuzumab

55 Alendronic acid

56 Alfacalcidol

57 Alfentanil

58 Alfuzosin

59 Alglucerase

60 Alglucosidase

61 Aliskiren

62 Alkyl sulfonals

63 Allergens

64 Allopurinol

65 Allylisopropylacetylurea; at all strengths

66 Allyloestrenol

67 Alosetron

68 Alpha₁-proteinase inhibitor

69 Alphadolone

70 Alphaxalone

71 Alprazolam

72 Alprenolol

73 Alprostadil

74 Alseroxylon

75 Alteplase

76 Altretamine

77 Amantadine

78 Ambenonium

79 Ambrisentan

80 Ambucetamide

81 Ambutonium

82 Amcinonide

83 Amethocaine; for internal use; for external use in medicines containing more than 10%; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

84 Amfebutamone

85 Amfepramone

86 Amidopyrine

87 Amifostine

88 Amikacin

89 Amiloride

90 Aminocaproic acid

91 Aminoglutethimide

92 Aminometradine

93 Aminophenazone; at all strengths

94 Aminophylline; except for oral use in liquid form in medicines containing 2% or less

95 Aminopterin

96 Aminorex

97 Aminosalicylic acid

98 Amiodarone

99 Amiphenazole

100 Amisometradine

101 Amisulpride

102 Amitriptyline

103 Amlodipine

104 Ammi visnaga

105 Ammonium bromide

106 Amobarbital

107 Amodiaquine

108 Amorolfine; except for external use

109 Amoxapine

110 Amoxycillin

111 Amphomycin

112 Amphotericin

113 Ampicillin

114 Amprenavir

115 Amrinone

116 Amsacrine

117 Amygdalin; at all strengths

118 Amyl nitrite; except when sold to a person who holds a controlled substances licence (issued under section 95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide

119 Amylocaine

120 Anabolic steroids

121 Anagrelide

122 Anakinra

123 Anastrozole

124 Ancestim

125 Anchusa officinalis; at all strengths

126 Ancrod and its immunoglobulin antidote

127 Androgenic and anabolic steroidal agents

128 Androgens

129 Androisoxazole

130 Androstanolone

131 Androstenediol

132 Androstenedione

133 Anecortave

134 Angiotensinamide

135 Anidulafungin

136 Anistreplase

137 Antazoline; except for ophthalmic use

138 Antibiotic substances; except when specified elsewhere in this schedule

139 Antigens

140 Antihistamines; except when specified elsewhere in this schedule

141 Antimony; except in medicines containing 1 milligram or less per litre or per kilogram

142 Antisera; for injection

143 Apocynum spp.

144 Apomorphine; except in medicines containing 1 milligram or less per litre or per kilogram

145 Apraclonidine

146 Aprepitant

147 Apronal

148 Aprotinin

149 Arecoline

150 Aripiprazole

151 Aristolochia spp.; at all strengths

152 Aristolochic acid; at all strengths

153 Arsenic; except in medicines containing 1 milligram or less per litre or per kilogram

154 Artemether

155 Articaine

156 Asparaginase

157 Aspirin; for injection; when combined with caffeine, paracetamol, or salicylamide

158 Astemizole

159 Atamestane

160 Atazanavir

161 Atenolol

162 Atomoxetine

163 Atorvastatin

164 Atosiban

165 Atovaquone

166 Atracurium

167 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

168 Atropine; except when specified elsewhere in this schedule; except when used as an antidote in a device designed for self-injection; except in medicines containing 300 micrograms or less per litre or per kilogram

169 Atropine methonitrate

170 Auranofin

171 Aurothiomalate sodium

172 Aviptadil

173 Azacitidine

174 Azacyclonol

175 Azapropazone

176 Azaribine

177 Azatadine; except when specified elsewhere in this schedule

178 Azathioprine

179 Azelaic acid; except for dermal use

180 Azelastine; except when specified elsewhere in this schedule

181 Azithromycin

182 Azlocillin

183 Aztreonam

184 Bacampicillin

185 Bacitracin

186 Baclofen

187 Balsalazide

188 Bambuterol

189 Bamethan

190 Bamipine

191 Barbital

192 Barbiturates

193 Basiliximab

194 Bazedoxifene

195 Becaplermin

196 Beclamide

197 Beclomethasone; except when specified elsewhere in this schedule

198 Bemegride

199 Benactyzine

200 Benazepril

201 Bendrofluazide

202 Benethamine penicillin

203 Benorylate

204 Benoxaprofen

205 Benperidol

206 Benserazide

207 Benzathine penicillin

208 Benzatropine

209 Benzhexol

210 Benzilonium

211 Benzocaine; except when specified elsewhere in this schedule; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit

212 Benzodiazepines

213 Benzoyl metronidazole

214 Benzoyl peroxide; except for external use in medicines containing 10% or less

215 Benzthiazide

216 Benzydamine; for internal use

217 Benzylpenicillin

218 Bepridil

219 Beractant

220 Beta carotene; in medicines containing more than 18 milligrams per recommended daily dose

221 Betahistine

222 Betamethasone

223 Betaxolol

224 Bethanechol

225 Bethanidine

226 Bevacizumab

227 Bevantolol

228 Bexarotene

229 Bezafibrate

230 Bicalutamide

231 Bifonazole; except for dermal use

232 Bimatoprost

233 Biperiden

234 Bismuth; except for external use in medicines containing 3% or less

235 Bisoprolol

236 Bithionol; at all strengths

237 Bivalirudin

238 Bleomycin

239 Bolandiol

240 Bolasterone

241 Bolazine

242 Boldenone

243 Bolenol

244 Bolmantalate

245 Boron including borax and boric acid; except for internal use in medicines containing 6 milligrams or less per recommended daily dose; except in dermal medicines for use other than paediatric use containing 0.35% or less; except when present as an excipient

246 Bortezomib

247 Bosentan

248 Botulinum toxins

249 Bretylium

250 Brimonidine

251 Brinzolamide

252 Bromazepam

253 Bromocriptine

254 Bromoform

255 Brompheniramine; except when specified elsewhere in this schedule

256 Bromvaletone

257 Brotizolam

258 Brugmansia spp.

259 Buclizine; except for oral use

260 Budesonide; except when specified elsewhere in this schedule

261 Bufexamac; except in suppositories or for dermal use in medicines containing 5% or less

262 Bumetanide

263 Buniodyl sodium; at all strengths

264 Buphenine

265 Bupivacaine

266 Buprenorphine

267 Bupropion

268 Buserelin

269 Buspirone

270 Busulphan

271 Butacaine

272 Butobarbital

273 Butoconazole; except for vaginal use

274 Butorphanol

275 Butyl aminobenzoate; except for dermal use in medicines containing 2% or less

276 Butyl nitrite

277 Butylchloral hydrate

278 Cabergoline

279 Cacalia spp.; at all strengths

280 Cadmium

281 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 previously diagnosed by a doctor

282 Calcitonin

283 Calcitriol

284 Calcium carbimide

285 Calcium polystyrene sulphonate

286 Calotropis gigantea

287 Calotropis procera

288 Calusterone

289 Camazepam

290 Camphorated oil

291 Camphotamide

292 Canakinumab

293 Candesartan

294 Candicidin

295 Cannabidiol

296 Capecitabine

297 Capreomycin

298 Captodiame

299 Captopril

300 Capuride

301 Caramiphen

302 Carbachol

303 Carbamazepine

304 Carbaryl; except for external use in medicines containing 2% or less

305 Carbazochrome

306 Carbenicillin

307 Carbenoxolone; for internal use

308 Carbetocin

309 Carbidopa

310 Carbimazole

311 Carbocromen

312 Carboplatin

313 Carboprost

314 Carbromal

315 Carbutamide

316 Carbuterol

317 Carindacillin

318 Carisoprodol

319 Carmustine

320 Carprofen

321 Carvedilol

322 Caspofungin

323 Cefacetrile

324 Cefaclor

325 Cefaloridine

326 Cefamandole

327 Cefapirin

328 Cefazolin

329 Cefepime

330 Cefetamet

331 Cefixime

332 Cefodizime

333 Cefonicid

334 Cefoperazone

335 Cefotaxime

336 Cefotetan

337 Cefotiam

338 Cefoxitin

339 Cefpirome

340 Cefpodoxime

341 Cefsulodin

342 Ceftazidime

343 Ceftibuten

344 Ceftriaxone

345 Cefuroxime

346 Celecoxib

347 Celiprolol

348 Cephaelis acuminata; except in medicines containing less than 0.2% of emetine

349 Cephaelis ipecacuanha; except in medicines containing less than 0.2% of emetine

350 Cephalexin

351 Cephalothin

352 Cephradine

353 Cerivastatin

354 Certolizumab pegol

355 Ceruletide

356 Cetirizine; except for oral use

357 Cetrorelix

358 Cetuximab

359 Chenodeoxycholic acid

360 Chloral hydrate; except for dermal use in medicines containing 2% or less

361 Chloralformamide

362 Chloralose

363 Chlorambucil

364 Chloramphenicol; except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when specified elsewhere in this schedule

365 Chlorandrostenolone

366 Chlorazanil

367 Chlorcyclizine

368 Chlordiazepoxide

369 Chlormerodrin

370 Chlormethiazole

371 Chlormezanone

372 Chloroform; for anaesthesia; except when specified elsewhere in this schedule

373 Chloroquine

374 Chlorothiazide

375 Chlorotrianisene

376 Chloroxydienone

377 Chloroxymesterone

378 Chlorpheniramine; except when specified elsewhere in this schedule

379 Chlorphentermine

380 Chlorpromazine

381 Chlorpropamide

382 Chlorprothixene

383 Chlorquinaldol

384 Chlortetracycline

385 Chlorthalidone

386 Chlorzoxazone

387 Cholera vaccine

388 Choline salicylate; except in medicines containing 10% or less and in pack sizes of 15 grams or less

389 Chorionic gonadotrophin; except in pregnancy test kits

390 Chymopapain

391 Ciclacillin

392 Ciclesonide

393 Ciclopirox; except for external use

394 Cidofovir

395 Cilastatin

396 Cilazapril

397 Cilostazol

398 Cimetidine; except when specified elsewhere in this schedule

399 Cinacalcet

400 Cinchocaine; for injection; for ophthalmic use; for external use in medicines containing more than 0.5%

401 Cinchophen

402 Cinoxacin

403 Ciprofloxacin

404 Cisapride

405 Cisatracurium

406 Cisplatin

407 Citalopram

408 Cladribine

409 Clarithromycin

410 Clavulanic acid

411 Clemastine; except for oral use

412 Clemizole

413 Clenbuterol

414 Clevidipine

415 Clidinium

416 Clindamycin

417 Clioquinol; at all strengths

418 Clobazam

419 Clobetasol

420 Clobetasone; except when specified elsewhere in this schedule

421 Clocortolone

422 Clodronic acid

423 Clofarabine

424 Clofazimine

425 Clofenamide

426 Clofibrate

427 Clomiphene

428 Clomipramine

429 Clomocycline

430 Clonazepam

431 Clonidine

432 Clopamide

433 Clopidogrel

434 Clorexolone

435 Clorprenaline

436 Clostebol

437 Clotiazepam

438 Clotrimazole; except when specified elsewhere in this schedule

439 Cloxacillin

440 Cloxazolam

441 Clozapine

442 Cobalt

443 Cocaine; except when specified elsewhere in this schedule

444 Codeine; except when specified elsewhere in this schedule

445 Co-dergocrine

446 Colaspase

447 Colchicine

448 Colchicum

449 Colecalciferol; in medicines containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations

450 Colestipol

451 Colestyramine

452 Colfosceril

453 Colistin

454 Collagen; in injections or implants for tissue augmentation or cosmetic use

455 Conium maculatum; at all strengths

456 Convallaria keiski

457 Convallaria majales

458 Corifollitropin alfa

459 Coronilla spp.

460 Corticosterone

461 Corticotrophin

462 Cortisone and other steroidal hormones of the adrenal cortex; except when specified elsewhere in this schedule; except adrenal extract for dermal use in medicines containing 0.02% or less of ketosteroids

463 Cotarnine; at all strengths

464 Co-trimoxazole

465 Coumarin

466 Crotalaria spp.; at all strengths

467 Croton tiglium; except in medicines containing 1 milligram or less per litre or per kilogram

468 Crystal violet

469 Curare

470 Cyclandelate

471 Cyclizine; except for oral use

472 Cyclobenzaprine

473 Cyclofenil

474 Cycloheximide

475 Cyclopenthiazide

476 Cyclopentolate; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

477 Cyclophosphamide

478 Cyclopropane

479 Cycloserine

480 Cyclosporin

481 Cyclothiazide

482 Cycrimine

483 Cymarin

484 Cynoglossum spp.; at all strengths

485 Cyproheptadine; except for oral use

486 Cyproterone

487 Cysteamine

488 Cytarabine

489 Dabigatran

490 Dacarbazine

491 Daclizumab

492 Dactinomycin

493 Dalfopristin

494 Dalteparin

495 Danaparoid

496 Danazol

497 Danthron

498 Dantrolene

499 Dapoxetine

500 Dapsone

501 Daptomycin

502 Darbepoetin

503 Darifenacin

504 Darunavir

505 Dasatinib

506 Datura spp.; except for oral use when specified elsewhere in this schedule; except datura stramonium or datura tatula for smoking or burning

507 Daunorubicin

508 Deanol

509 Debrisoquine

510 Decamethonium

511 Deferasirox

512 Deferiprone

513 Deflazacort

514 Dehydrochloromethyltestosterone

515 Dehydrocorticosterone

516 Delavirdine

517 Delorazepam

518 Demecarium

519 Demeclocycline

520 Deoxycortone

521 Deoxyribonuclease; except for external use

522 Desferrioxamine

523 Desflurane

524 Desipramine

525 Desirudin

526 Deslanoside

527 Desloratadine; except for oral use

528 Deslorelin

529 Desmopressin

530 Desogestrel

531 Desonide

532 Desoximetasone

533 Desvenlafaxine

534 Dexamethasone

535 Dexamfetamine

536 Dexchlorpheniramine; except when specified elsewhere in this schedule

537 Dexfenfluramine

538 Dexmedetomidine

539 Dextromethorphan; except when specified elsewhere in this schedule

540 Dextromoramide

541 Dextropropoxyphene

542 Dextrorphan

543 Di-iodohydroxy quinoline; except for vaginal use

544 Di-isopropylamine dichloroacetate

545 Diazepam

546 Diazoxide

547 Dibenzepin

548 Dibotermin

549 Dibrompropamidine; except for ophthalmic use

550 Dichloralphenazone

551 Dichlorophen

552 Dichlorphenamide

553 Diclofenac; except when specified elsewhere in this schedule; except for external use

554 Dicloxacillin

555 Dicyclomine

556 Didanosine

557 Dienoestrol

558 Dienogest

559 Diethazine

560 Diethylcarbamazine

561 Diethylstilbestrol

562 Diflorasone

563 Diflucortolone

564 Diflunisal

565 Digitalis lanata

566 Digitalis purpurea

567 Digitoxin

568 Digoxin

569 Digoxin-specific antibody fragment

570 Dihydralazine

571 Dihydrocodeine

572 Dihydroergotoxine

573 Dihydrolone

574 Dihydrotachysterol

575 Diltiazem

576 Dimenhydrinate; except when specified elsewhere in this schedule

577 Dimercaprol

578 Dimethandrostanolone

579 Dimethazine

580 Dimethindene; except for oral use

581 Dimethothiazine

582 Dimethoxanate

583 Dimethyl sulphoxide

584 Dinitrocresols

585 Dinitronaphthols

586 Dinitrophenols

587 Dinitrothymols

588 Dinoprost

589 Dinoprostone

590 Diperodon

591 Diphemanil; except for dermal use

592 Diphenhydramine; except when specified elsewhere in this schedule

593 Diphenidol

594 Diphenoxylate; except when specified elsewhere in this schedule

595 Diphenylpyraline

596 Diphtheria toxoid

597 Diphtheria vaccine

598 Dipivefrin

599 Dipyridamole

600 Dirithromycin

601 Disopyramide

602 Distigmine

603 Disulfiram

604 Disulphamide

605 Ditiocarb

606 Dobutamine

607 Docetaxel

608 Dofetilide

609 Dolasetron

610 Domperidone

611 Donepezil

612 Dopamine

613 Dopexamine

614 Doripenem

615 Dornase

616 Dorzolamide

617 Dothiepin

618 Doxantrazole

619 Doxapram

620 Doxazosin

621 Doxepin

622 Doxorubicin

623 Doxycycline

624 Doxylamine; except when specified elsewhere in this schedule

625 Droperidol

626 Drospirenone

627 Drostanolone

628 Drotrecogin

629 Duboisia leichhardtii; except when specified elsewhere in this schedule

630 Duboisia myoporides; except when specified elsewhere in this schedule

631 Dulcin; at all strengths

632 Duloxetine

633 Dutasteride

634 Dydrogesterone

635 Econazole; except when specified elsewhere in this schedule

636 Ecothiopate

637 Ectylurea

638 Edetic acid; in medicines containing more than 0.25%; except in contact lens preparations; except dicobalt edetate for the treatment of cyanide poisoning

639 Edoxudine

640 Edrophonium

641 Efalizumab

642 Efavirenz

643 Eflornithine

644 Eletriptan

645 Eltrombopag olamine

646 Emepronium

647 Emetine; in medicines containing more than 0.2%

648 Emtricitabine

649 Enalapril

650 Enestebol

651 Enflurane

652 Enfuvirtide

653 Enoxacin

654 Enoxaparin

655 Enoximone

656 Enprostil

657 Entacapone

658 Entecavir

659 Ephedrine

660 Epicillin

661 Epinastine

662 Epirubicin

663 Epitiostanol

664 Eplerenone

665 Epoetins

666 Epoprostenol

667 Eprosartan

668 Eptifibatide

669 Ergocalciferol; in medicines containing more than 25 micrograms per recommended daily dose

670 Ergometrine

671 Ergot

672 Ergotamine

673 Ergotoxine

674 Erlotinib

675 Ertapenem

676 Erysimum spp.; except in medicines containing 1 milligram or less per litre or per kilogram

677 Erythromycin

678 Erythropoietin

679 Escitalopram

680 Esmolol

681 Esomeprazole

682 Estazolam

683 Estramustine

684 Estropipate

685 Etanercept

686 Ethacrynic acid

687 Ethambutol

688 Ethamivan

689 Ethanolamine; for injection

690 Ethchlorvynol

691 Ether; for anaesthesia

692 Ethinamate

693 Ethinyloestradiol

694 Ethionamide

695 Ethisterone

696 Ethoglucid

697 Ethoheptazine

698 Ethopropazine

699 Ethosuximide

700 Ethotoin

701 Ethoxzolamide

702 Ethyl chloride; for inhalation

703 Ethyl loflazepate

704 Ethyldienolone

705 Ethylhexanediol; at all strengths

706 Ethyloestrenol

707 Ethynodiol

708 Etidocaine

709 Etidronic acid; except in medicines for external use containing 1% or less

710 Etilefrine

711 Etodolac

712 Etofenamate; except for external use

713 Etonogestrel

714 Etoposide

715 Etoricoxib

716 Etravirine

717 Etretinate

718 Everolimus

719 Exemestane

720 Exenatide

721 Ezetimibe

722 Factor VIII inhibitor bypassing fraction

723 Famciclovir; except when specified elsewhere in this schedule

724 Famotidine; except when specified elsewhere in this schedule

725 Fampridine

726 Farfugium japonicum; at all strengths

727 Felbinac; except for external use

728 Felodipine

729 Felypressin; except when combined with a local anaesthetic and used in practice by a dental therapist registered with the Dental Council

730 Fenbufen

731 Fenclofenac

732 Fenfluramine

733 Fenofibrate

734 Fenoldopam

735 Fenoprofen

736 Fenoterol

737 Fenpipramide

738 Fenpiprane

739 Fentanyl

740 Fexofenadine; except for oral use

741 Fibrin

742 Fibrinolysin; except for external use

743 Filgrastim

744 Finasteride

745 Flecainide

746 Fleroxacin

747 Floctafenine

748 Fluanisone

749 Fluclorolone

750 Flucloxacillin

751 Fluconazole; except when specified elsewhere in this schedule

752 Flucytosine

753 Fludarabine

754 Fludiazepam

755 Fludrocortisone

756 Flufenamic acid

757 Flumazenil

758 Flumethasone

759 Flumethiazide

760 Flunisolide

761 Flunitrazepam

762 Fluocinolone

763 Fluocinonide

764 Fluocortin

765 Fluocortolone

766 Fluorescein; for injection

767 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 external 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 Council

768 Fluorometholone

769 Fluorouracil

770 Fluoxetine

771 Fluoxymesterone

772 Flupenthixol

773 Fluphenazine

774 Flurandrenolone

775 Flurazepam dihydrochloride

776 Flurbiprofen; except in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit

777 Fluroxene

778 Fluspirilene

779 Flutamide

780 Fluticasone; except when specified elsewhere in this schedule

781 Fluvastatin

782 Fluvoxamine

783 Folic acid; for injection except in parenteral nutrition replacement preparations

784 Folinic acid; for injection

785 Follicle-stimulating hormone; except in medicines containing 100 micrograms or less per litre or per kilogram

786 Follitropin

787 Fomivirsen

788 Fondaparinux

789 Formebolone

790 Formestane

791 Formoterol

792 Fosamprenavir

793 Fosaprepitant

794 Foscarnet

795 Fosfestrol

796 Fosinopril

797 Fosphenytoin

798 Fotemustine

799 Framycetin

800 Fulvestrant

801 Furaltadone

802 Furazabol

803 Furazolidone

804 Furosemide

805 Fusidic acid

806 Gabapentin

807 Galantamine

808 Galanthus spp.

809 Gallamine

810 Galsulfase

811 Ganciclovir

812 Ganirelix

813 Gatifloxacin

814 Gefitinib

815 Gemcitabine

816 Gemeprost

817 Gemfibrozil

818 Gemifloxacin

819 Gemtuzumab ozogamicin

820 Gentamicin

821 Gestodene

822 Gestonorone

823 Gestrinone

824 Gitalin

825 Glatiramer acetate

826 Glibenclamide

827 Glibornuride

828 Gliclazide

829 Glimepiride

830 Glipizide

831 Glisoxepide

832 Glutathione; for injection

833 Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram

834 Glycopyrronium; for injection

835 Glymidine

836 Golimumab

837 Gonadorelin

838 Gonadotrophic hormones; except when specified elsewhere in this schedule

839 Goserelin

840 Gramicidin

841 Granisetron

842 Grepafloxacin

843 Griseofulvin

844 Guaiphenesin; for oral use in medicines containing more than 2% or 200 milligrams per dose form except when specified elsewhere in this schedule; except for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams sold in a pack containing not more than 5 days' supply approved by the Minister or the Director-General for distribution as a general sale medicine

845 Guanabenz

846 Guanethidine

847 Guanidine

848 Hachimycin

849 Haematin

850 Haemophilus influenzae vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

851 Halazepam

852 Halcinonide

853 Halofantrine

854 Halofenate

855 Haloperidol; except in medicines containing 1 milligram or less per litre or per kilogram

856 Halothane

857 Haloxazolam

858 Halquinol; for internal use

859 Heliotropium spp.; at all strengths

860 Hemerocallis

861 Heparins; for internal use; except when present as an excipient

862 Hepatitis A vaccine

863 Hepatitis B vaccine

864 Hetacillin

865 Hexachlorophane; in medicines containing more than 3%

866 Hexamethonium

867 Hexetidine; for internal use

868 Hexobendine

869 Hexocyclium

870 Hexoprenaline

871 Histamine; in medicines containing more than 0.5%

872 Homatropine

873 Human chorionic gonadotrophin; except in pregnancy test kits

874 Human papillomavirus vaccine

875 Human protein C

876 Hyaluronic acid; in injections or implants for tissue augmentation or cosmetic use

877 Hydralazine

878 Hydrargaphen

879 Hydrochlorothiazide

880 Hydrocortisone; except when specified elsewhere in this schedule

881 Hydrocyanic acid; except when specified elsewhere in this schedule; except in medicines containing 1 microgram or less per litre or per kilogram

882 Hydroflumethiazide

883 Hydromorphone

884 Hydroquinone; except in medicines for external use containing 2% or less

885 Hydroxychloroquine

886 Hydroxyephedrine

887 Hydroxyphenamate

888 Hydroxyprogesterone

889 Hydroxystenozol

890 Hydroxyurea

891 Hydroxyzine

892 Hylan polymer; in injections or implants for tissue augmentation or cosmetic use

893 Hyoscine; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less per litre or per kilogram

894 Hyoscine butylbromide; except when specified elsewhere in this schedule

895 Hyoscyamine; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less per litre or per kilogram

896 Hyoscyamus niger; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram

897 Hypothalamic releasing factors

898 Hypromellose; for injection; except in intraocular viscoelastic products

899 Ibandronic acid

900 Ibogaine

901 Ibritumomab tiuxetan

902 Ibufenac

903 Ibuprofen; except when specified elsewhere in this schedule

904 Ibuterol

905 Ibutilide

906 Idarubicin

907 Idoxuridine; except for dermal use in medicines containing 0.5% or less

908 Idursulfase

909 Ifosfamide

910 Iloprost

911 Imatinib

912 Imiglucerase

913 Imipenem

914 Imipramine

915 Imiquimod

916 Immunoglobulins

917 Indapamide

918 Indinavir

919 Indomethacin; except for external use in medicines containing 1% or less; except in medicines containing 1 milligram or less per litre or per kilogram

920 Indoprofen

921 Indoramin

922 Infliximab

923 Influenza and coryza vaccines; for injection; for nasal use

924 Insulins

925 Interferons

926 Interleukins

927 Iodothiouracil

928 Ipecacuanha; except in medicines containing less than 0.2% of emetine

929 Ipratropium; except for nasal use

930 Ipriflavone

931 Iprindole

932 Iproniazid

933 Irbesartan

934 Irinotecan

935 Iron; for injection except in parenteral nutrition replacement preparations

936 Isoaminile

937 Isoamyl nitrite

938 Isobutyl nitrite

939 Isocarboxazid

940 Isoconazole; except when specified elsewhere in this schedule

941 Isoetarine

942 Isoflurane

943 Isometheptene

944 Isoniazid

945 Isoprenaline

946 Isoprinosine

947 Isopropamide; except for dermal use in preparations containing 2% or less

948 Isosorbide dinitrate

949 Isosorbide mononitrate

950 Isotretinoin

951 Isoxicam

952 Isoxsuprine

953 Isradipine

954 Itraconazole

955 Ivabradine

956 Ivermectin

957 Ixabepilone

958 Japanese encephalitis vaccine

959 Juniperus sabina; at all strengths

960 Kanamycin

961 Ketamine

962 Ketanserin

963 Ketazolam

964 Ketoconazole; except for dermal use

965 Ketoprofen; except when specified elsewhere in this schedule; except for dermal use

966 Ketorolac

967 Ketotifen; except for ophthalmic use in medicines containing 0.025% or less

968 Khellin

969 Labetalol

970 Lacidipine

971 Lacosamide

972 Lamivudine

973 Lamotrigine

974 Lanatosides

975 Lanreotide

976 Lansoprazole; except when specified elsewhere in this schedule

977 Lanthanum

978 Lapatinib

979 Laronidase-rch

980 Laropiprant

981 Latamoxef

982 Latanoprost

983 Laudexium

984 Lauromacrogols; for injection

985 Lead

986 Lefetamine

987 Leflunomide

988 Lenalidomide

989 Lenograstim

990 Lepirudin

991 Leptazol

992 Lercanidipine

993 Letrozole

994 Leucovorin; for injection

995 Leuprorelin

996 Levallorphan

997 Levamisole

998 Levetiracetam

999 Levobunolol

1000 Levobupivacaine

1001 Levocabastine; except for nasal or ophthalmic use

1002 Levocetirizine; except for oral use

1003 Levodopa

1004 Levomepromazine

1005 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 sexual and reproductive health

1006 Levosimendan

1007 Lidoflazine

1008 Lignocaine; 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 Podiatry Board or dental therapist registered with the Dental Council; for oral use except in throat lozenges containing 30 milligrams or less per dose form; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for external use in medicines containing more than 10%

1009 Ligularia dentata; at all strengths

1010 Lincomycin

1011 Lindane; except for external use in medicines containing 2% or less

1012 Linezolid

1013 Liothyronine

1014 Liraglutide

1015 Lisinopril

1016 Lisuride

1017 Lithium; except when specified elsewhere in this schedule; except when present as an excipient in dermal medicines containing 0.25% or less

1018 Lodoxamide; except in medicines for ophthalmic use

1019 Lofexidine

1020 Lomefloxacin

1021 Lomustine

1022 Loperamide; except when specified elsewhere in this schedule

1023 Lopinavir

1024 Loprazolam

1025 Loracarbef

1026 Loratadine; except for oral use

1027 Lorazepam

1028 Lormetazepam

1029 Losartan

1030 Loxapine

1031 Lumefantrine

1032 Lumiracoxib

1033 Luteinising hormone

1034 Lymecycline

1035 Mafenide

1036 Mannomustine

1037 Maprotiline

1038 Maraviroc

1039 Mazindol

1040 Measles vaccine

1041 Mebanazine

1042 Mebeverine

1043 Mebhydrolin

1044 Mebolazine

1045 Mebutamate

1046 Mecamylamine

1047 Mecasermin

1048 Mecillinam

1049 Meclocycline

1050 Meclofenamate

1051 Meclofenoxate

1052 Meclozine; except when specified elsewhere in this schedule

1053 Medazepam

1054 Medigoxin

1055 Medroxyprogesterone

1056 Medrysone

1057 Mefenamic acid; except when specified elsewhere in this schedule

1058 Mefloquine

1059 Mefruside

1060 Megestrol

1061 Melagatran

1062 Melatonin

1063 Melengestrol

1064 Melia azedarach; at all strengths

1065 Meloxicam

1066 Melphalan

1067 Memantine

1068 Meningococcal vaccine

1069 Menotrophin

1070 Mepacrine

1071 Mepenzolate

1072 Mephenesin

1073 Mephentermine

1074 Mepindolol

1075 Mepitiostane

1076 Mepivacaine

1077 Meprobamate

1078 Meptazinol

1079 Mepyramine; except when specified elsewhere in this schedule

1080 Mequitazine

1081 Mercaptomerin

1082 Mercaptopurine

1083 Mercury; except when specified elsewhere in this schedule; except in medicines containing 1 milligram or less per litre or per kilogram

1084 Meropenem

1085 Mersalyl

1086 Mesabolone

1087 Mesalazine

1088 Mesna

1089 Mestanolone

1090 Mesterolone

1091 Mestranol

1092 Metamfetamine

1093 Metandienone

1094 Metaraminol

1095 Metenolone

1096 Metergoline

1097 Metformin

1098 Methacholine

1099 Methacycline

1100 Methadone

1101 Methallenoestril

1102 Methandriol

1103 Methanthelinium

1104 Methazolamide

1105 Methdilazine; except for oral use

1106 Methicillin

1107 Methimazole

1108 Methisazone

1109 Methixene

1110 Methocarbamol

1111 Methohexitone

1112 Methoin

1113 Methotrexate

1114 Methoxamine; except for external use

1115 Methoxsalen

1116 Methoxyflurane

1117 Methsuximide

1118 Methyclothiazide

1119 Methyl aminolevulinate

1120 Methyl androstanolone

1121 Methyl clostebol

1122 Methyl mercury; except in medicines containing 300 micrograms or less per litre or per kilogram

1123 Methyl salicylate; for internal use except when present as an excipient in medicines containing 1.04% or less per dose form

1124 Methyl trienolone

1125 Methyldopa

1126 Methylene blue; for injection

1127 Methylergometrine

1128 Methylnaltrexone

1129 Methylpentynol

1130 Methylphenidate

1131 Methylphenobarbital

1132 Methylprednisolone

1133 Methyltestosterone

1134 Methylthiouracil

1135 Methyprylon

1136 Methysergide

1137 Metoclopramide; except when specified elsewhere in this schedule

1138 Metolazone

1139 Metoprolol

1140 Metribolone

1141 Metrifonate

1142 Metronidazole

1143 Metyrapone

1144 Mexiletine

1145 Mezlocillin

1146 Mianserin

1147 Mibefradil

1148 Mibolerone

1149 Miconazole; except when specified elsewhere in this schedule

1150 Midazolam

1151 Midodrine

1152 Mifepristone

1153 Miglitol

1154 Miglustat

1155 Milrinone

1156 Minocycline

1157 Minoxidil; except for dermal use in medicines containing 5% or less

1158 Mirtazapine

1159 Misoprostol

1160 Mitobronitol

1161 Mitomycin

1162 Mitoxantrone

1163 Mitragyna speciosa

1164 Mitragynine

1165 Mivacurium

1166 Moclobemide

1167 Modafinil

1168 Molgramostim

1169 Molindone

1170 Mometasone; except when specified elsewhere in this schedule

1171 Monobenzone

1172 Monoclonal antibodies; except in pregnancy test kits

1173 Montelukast

1174 Moperone

1175 Morazone

1176 Moricizine

1177 Morphine; except when specified elsewhere in this schedule

1178 Motrazepam

1179 Motretinide

1180 Moxifloxacin

1181 Mumps vaccine

1182 Mupirocin

1183 Muraglitazar

1184 Muromonab

1185 Mustine

1186 Mycophenolic acid

1187 Nabilone

1188 Nabumetone

1189 Nadolol

1190 Nadroparin

1191 Nafarelin

1192 Naftidrofuryl

1193 Nalbuphine

1194 Nalidixic acid

1195 Nalorphine

1196 Naloxone

1197 Naltrexone

1198 Nandrolone

1199 Naproxen; except when specified elsewhere in this schedule

1200 Naratriptan

1201 Natalizumab

1202 Natamycin

1203 Nateglinide

1204 Nebacumab

1205 Nebivolol

1206 Nedocromil

1207 Nefazodone

1208 Nefopam

1209 Nelfinavir

1210 Neomycin

1211 Neostigmine

1212 Nepafenac

1213 Nerium oleander

1214 Nesiritide

1215 Netilmicin

1216 Nevirapine

1217 Nialamide

1218 Nicardipine

1219 Nicergoline

1220 Nicofuranose

1221 Nicorandil

1222 Nicotine; 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

1223 Nicotinic acid except nicotinamide; in medicines containing more than 250 milligrams per dose form

1224 Nicoumalone

1225 Nifedipine

1226 Nifenazone

1227 Nikethamide

1228 Nilotinib

1229 Nilutamide

1230 Nimesulide

1231 Nimetazepam

1232 Nimodipine

1233 Nimorazole

1234 Niridazole

1235 Nisoldipine

1236 Nitrazepam

1237 Nitrendipine

1238 Nitric oxide

1239 Nitrofurantoin

1240 Nitrofurazone

1241 Nitrous oxide

1242 Nitroxoline

1243 Nizatidine; except when specified elsewhere in this schedule

1244 Nomifensine

1245 Noradrenaline

1246 Norandrostenolone

1247 Norbolethone

1248 Norclostebol

1249 Nordazepam

1250 Norelgestromin

1251 Norethandrolone

1252 Norethisterone

1253 Norfloxacin

1254 Norgestrel

1255 Noribogaine

1256 Normethandrone

1257 Nortriptyline

1258 Noxiptyline

1259 Nux vomica; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine

1260 Nystatin; except when specified elsewhere in this schedule

1261 Octamylamine

1262 Octatropine

1263 Octreotide

1264 Octyl nitrite

1265 Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram

1266 Oestriol

1267 Oestrogens

1268 Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram

1269 Ofloxacin

1270 Olanzapine

1271 Oleandomycin

1272 Oleandrin

1273 Olmesartan

1274 Olopatadine

1275 Olsalazine

1276 Omalizumab

1277 Omeprazole; except when specified elsewhere in this schedule

1278 Ondansetron

1279 Opipramol

1280 Opium; except when specified elsewhere in this schedule

1281 Orciprenaline

1282 Orlistat; except in medicines for weight control containing 120 milligrams or less per dose form

1283 Ornidazole

1284 Ornipressin

1285 Orphenadrine

1286 Orthopterin

1287 Oseltamivir; except when sold in a pharmacy between the months of April to November inclusive by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza

1288 Ouabain

1289 Ovandrotone

1290 Oxabolone

1291 Oxacillin

1292 Oxaliplatin

1293 Oxandrolone

1294 Oxaprozin

1295 Oxazepam

1296 Oxazolam

1297 Oxcarbazepine

1298 Oxedrine; in medicines containing more than 30 milligrams per recommended daily dose

1299 Oxetacaine; except for internal use

1300 Oxiconazole; except when specified elsewhere in this schedule

1301 Oxitropium

1302 Oxolamine

1303 Oxolinic acid

1304 Oxpentifylline

1305 Oxprenolol

1306 Oxybuprocaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

1307 Oxybutynin

1308 Oxycodone

1309 Oxymesterone

1310 Oxymetholone

1311 Oxyphenbutazone

1312 Oxyphencyclimine

1313 Oxyphenisatin; at all strengths

1314 Oxyphenonium

1315 Oxytetracycline

1316 Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram

1317 Paclitaxel

1318 Palifermin

1319 Paliperidone

1320 Palivizumab

1321 Palonosetron

1322 Pamaquin

1323 Pamidronic acid

1324 Pancreatic enzymes; in medicines containing more than 20 000 BP units of lipase activity

1325 Pancuronium

1326 Panitumumab

1327 Pantoprazole; except when specified elsewhere in this schedule

1328 Papaveretum

1329 Papaverine; for injection

1330 Paracetamol; except when specified elsewhere in this schedule

1331 Paraldehyde

1332 Paramethadione

1333 Paramethasone

1334 Parecoxib

1335 Paricalcitol

1336 Paromomycin

1337 Paroxetine

1338 Pazopanib

1339 Pecazine

1340 Pefloxacin

1341 Pegaptanib

1342 Pegfilgrastim

1343 Peginterferon

1344 Pegvisomant

1345 Pemetrexed

1346 Pemoline

1347 Pempidine

1348 Penbutolol

1349 Penciclovir; except for external use for the treatment of herpes labialis

1350 Penicillamine

1351 Pentaerythrityl tetranitrate

1352 Pentagastrin

1353 Pentamethonium

1354 Pentamidine

1355 Pentazocine

1356 Penthienate

1357 Pentolinium

1358 Pentosan polysulfate sodium

1359 Pentoxifylline

1360 Pergolide

1361 Perhexiline

1362 Pericyazine

1363 Perindopril

1364 Permethrin; in medicines containing more than 5%

1365 Perphenazine

1366 Pertussis antigen

1367 Pertussis (whooping cough) vaccine

1368 Pethidine

1369 Phenacemide

1370 Phenacetin; except when present as an excipient

1371 Phenaglycodol

1372 Phenazone; except for external use

1373 Phenazopyridine

1374 Phenelzine

1375 Pheneticillin

1376 Phenformin

1377 Phenglutarimide

1378 Phenindione

1379 Pheniramine; except when specified elsewhere in this schedule

1380 Phenisatin

1381 Phenobarbital

1382 Phenol; for injection

1383 Phenolphthalein

1384 Phenoperidine

1385 Phenoxybenzamine

1386 Phenoxymethylpenicillin

1387 Phensuximide

1388 Phentermine

1389 Phenthimentonium

1390 Phentolamine

1391 Phenylbutazone

1392 Phenylephrine; except when specified elsewhere in this schedule

1393 Phenylpropanolamine

1394 Phenyltoloxamine

1395 Phenytoin

1396 Pholcodine; except when specified elsewhere in this schedule

1397 Phosphodiesterase type 5 inhibitors; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in this schedule

1398 Phthalylsulfathiazole

1399 Physostigmine

1400 Picric acid

1401 Picrotoxin

1402 Pilocarpine; except in medicines containing 0.025% or less

1403 Pimecrolimus

1404 Pimozide

1405 Pinacidil

1406 Pinazepam

1407 Pindolol

1408 Pioglitazone

1409 Pipecuronium

1410 Pipemidic acid

1411 Pipenzolate

1412 Piperacillin

1413 Piperidine

1414 Piperidolate

1415 Pipobroman

1416 Pipothiazine

1417 Pipradrol

1418 Piracetam

1419 Pirbuterol

1420 Pirenoxine

1421 Pirenzepine

1422 Piretanide

1423 Piroxicam; except for external use

1424 Pirprofen

1425 Pituitary hormones

1426 Pivampicillin

1427 Pizotifen

1428 Plicamycin

1429 Pneumococcal vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

1430 Podophyllotoxin; for internal use; for external use for the treatment of anogenital 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 kilogram

1431 Podophyllum emodi; 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 podophyllin per litre or per kilogram

1432 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 podophyllin per litre or per kilogram

1433 Polidexide

1434 Poliomyelitis vaccine

1435 Polyacrylamide; in injections or implants for tissue augmentation or cosmetic use

1436 Polyestradiol

1437 Polylactic acid; in injections or implants for tissue augmentation or cosmetic use

1438 Polymyxin

1439 Polysulfated glycosaminoglycans; for injection except in intraocular viscoelastic products

1440 Polythiazide

1441 Poractant alfa

1442 Posaconazole

1443 Potassium bromide

1444 Potassium perchlorate

1445 Practolol

1446 Pralidoxime

1447 Pramipexole

1448 Pramocaine

1449 Prampine

1450 Prasterone

1451 Prasugrel

1452 Pravastatin

1453 Prazepam

1454 Praziquantel

1455 Prazosin

1456 Prednisolone

1457 Prednisone

1458 Pregabalin

1459 Pregnenolone

1460 Prenalterol

1461 Prenylamine

1462 Prilocaine; for injection except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council; except when specified elsewhere in this schedule

1463 Primaquine

1464 Primidone

1465 Probenecid

1466 Probucol

1467 Procainamide

1468 Procaine

1469 Procaine penicillin

1470 Procarbazine

1471 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 contraception

1472 Procyclidine; except for dermal use in medicines containing 5% or less

1473 Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram

1474 Progestogens

1475 Proglumide

1476 Proguanil

1477 Prolintane

1478 Promazine

1479 Promethazine; except when specified elsewhere in this schedule

1480 Promoxolane

1481 Propafenone

1482 Propamidine; except for ophthalmic use

1483 Propanidid

1484 Propantheline

1485 Propetandrol

1486 Propionibacterium acnes

1487 Propofol

1488 Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram

1489 Propylthiouracil

1490 Propyphenazone

1491 Proquazone

1492 Proscillaridin

1493 Prostaglandins

1494 Protamine

1495 Prothionamide

1496 Prothipendyl

1497 Protirelin

1498 Protoveratrines

1499 Protriptyline

1500 Proxymetacaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

1501 Pseudoephedrine; except when specified elsewhere in this schedule

1502 Pulmonaria spp.; at all strengths

1503 Pyrazinamide

1504 Pyridinolcarbamate

1505 Pyridostigmine

1506 Pyridoxal; in medicines containing more than 200 milligrams per recommended daily dose

1507 Pyridoxamine; in medicines containing more than 200 milligrams per recommended daily dose

1508 Pyridoxine; in medicines containing more than 200 milligrams per recommended daily dose

1509 Pyrimethamine

1510 Pyrvinium

1511 Quazepam

1512 Quetiapine

1513 Quinagolide

1514 Quinapril

1515 Quinbolone

1516 Quinethazone

1517 Quinidine

1518 Quinine; except in medicines containing 50 milligrams or less per recommended daily dose

1519 Quinisocaine

1520 Quinupristin

1521 Rabeprazole

1522 Rabies vaccine

1523 Raloxifene

1524 Raltegravir

1525 Raltitrexed

1526 Ramipril

1527 Ranibizumab

1528 Ranitidine; except when specified elsewhere in this schedule; except in medicines containing 150 milligrams or less per dose unit that have received the consent of the Minister or the Director-General to their distribution as general sale medicines and that are sold in the manufacturer's original pack containing not more than 7 days' supply

1529 Rapacuronium

1530 Rasagiline

1531 Rasburicase

1532 Rauwolfia serpentina

1533 Rauwolfia vomitoria

1534 Razoxane

1535 Reboxetine

1536 Remifentanil

1537 Remoxipride

1538 Repaglinide

1539 Reserpine

1540 Reteplase

1541 Ribavirin

1542 Rifabutin

1543 Rifampicin

1544 Rifamycin

1545 Rifapentine

1546 Riluzole

1547 Rimexolone

1548 Rimiterol

1549 Rimonabant

1550 Risedronic acid

1551 Risperidone

1552 Ritodrine

1553 Ritonavir

1554 Rituximab

1555 Rivaroxaban

1556 Rivastigmine

1557 Rizatriptan; except when specified elsewhere in this schedule

1558 Rocuronium

1559 Rofecoxib

1560 Roflumilast

1561 Rolitetracycline

1562 Romiplostim

1563 Ropinirole

1564 Ropivacaine

1565 Rosiglitazone

1566 Rosoxacin

1567 Rosuvastatin

1568 Rotavirus vaccine

1569 Rotigotine

1570 Roxibolone

1571 Roxithromycin

1572 Rubella vaccine

1573 Ruboxistaurin

1574 Sabadilla; except in preparations containing 10 milligrams or less of total alkaloids of Schoenocaulon officinale per litre or per kilogram

1575 Safrole; for internal use except in medicines containing 0.1% or less

1576 Salbutamol

1577 Salcatonin

1578 Salmeterol

1579 Saquinavir

1580 Saxagliptin

1581 Schoenocaulon officinale; except in preparations containing 10 milligrams or less of total alkaloids of Schoenocaulon officinale per litre or per kilogram

1582 Scopolia carniolica

1583 Secbutabarbital

1584 Secobarbital

1585 Selegiline

1586 Selenium; except when specified elsewhere in this schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose; except for external use in medicines containing 3.5% or less of selenium sulphide

1587 Sermorelin

1588 Sertindole

1589 Sertraline

1590 Serum, dried human

1591 Sevelamer

1592 Sevoflurane

1593 Sex hormones and all substances having sex hormone activity

1594 Sialoepoetin

1595 Sibutramine

1596 Silandrone

1597 Sildenafil and its structural analogues

1598 Silicones; for injection

1599 Silver sulfadiazine; except for external use in packs containing 50 grams or less

1600 Simvastatin

1601 Sirolimus

1602 Sisomicin

1603 Sitagliptin

1604 Sitaxentan

1605 Sodium bromide

1606 Sodium cellulose phosphate; for internal use

1607 Sodium cromoglycate; except for nasal and ophthalmic use

1608 Sodium morrhuate; for injection

1609 Sodium nitroprusside

1610 Sodium phosphate; in oral laxative preparations

1611 Sodium polystyrene sulphonate

1612 Sodium tetradecyl sulphate; for injection

1613 Solasadine

1614 Solifenacin

1615 Somatostatin

1616 Somatropin

1617 Sontoquine

1618 Sorafenib

1619 Sotalol

1620 Sparfloxacin

1621 Sparteine

1622 Spectinomycin

1623 Spiramycin

1624 Spirapril

1625 Spironolactone

1626 Stanolone

1627 Stanozolol

1628 Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

1629 Stavudine

1630 Stenbolone

1631 Steroid hormones

1632 Stilboestrol

1633 Stramonium; except for oral use where specified elsewhere in this schedule; except Datura stramonium or Datura tatula for smoking or burning

1634 Streptococcus beta-haemolyticus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

1635 Streptodornase

1636 Streptokinase

1637 Streptomycin

1638 Strontium ranelate

1639 Strophanthins

1640 Strophanthus spp.

1641 Strychnos spp.; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine

1642 Styramate

1643 Succimer

1644 Sufentanil

1645 Sugammadex

1646 Sulbactam

1647 Sulconazole; except for dermal use

1648 Sulfacetamide; except for ophthalmic use in medicines containing 10% or less

1649 Sulfadiazine; except silver sulfadiazine for external use in pack sizes of 50 grams or less

1650 Sulfadimethoxine

1651 Sulfadimidine

1652 Sulfadoxine

1653 Sulfafurazole

1654 Sulfaguanidine

1655 Sulfamerazine

1656 Sulfamethizole

1657 Sulfamethoxazole

1658 Sulfamethoxydiazine

1659 Sulfamethoxypyridazine

1660 Sulfametrole

1661 Sulfamonomethoxine

1662 Sulfamoxole

1663 Sulfaphenazole

1664 Sulfapyridine

1665 Sulfasalazine

1666 Sulfathiazole

1667 Sulfatroxazole

1668 Sulfinpyrazone

1669 Sulfomyxin

1670 Sulfonmethane

1671 Sulindac

1672 Sultamicillin

1673 Sulthiame

1674 Sumatriptan; except when specified elsewhere in this schedule

1675 Sunitinib

1676 Suprofen

1677 Sutilains

1678 Suxamethonium

1679 Suxethonium

1680 T cell receptor antibody

1681 Tacrine

1682 Tacrolimus

1683 Tadalafil and its structural analogues

1684 Tamoxifen

1685 Tamsulosin

1686 Tanacetum vulgare; in medicines containing more than 0.8% of oil of tansy

1687 Tapentadol

1688 Tasonermin

1689 Tazarotene

1690 Tazobactam

1691 Tegafur

1692 Tegaserod

1693 Teicoplanin

1694 Telbivudine

1695 Telithromycin

1696 Telmisartan

1697 Temazepam

1698 Temozolomide

1699 Temsirolimus

1700 Tenecteplase

1701 Teniposide

1702 Tenofovir

1703 Tenoxicam

1704 Terazosin

1705 Terbinafine; except when specified elsewhere in this schedule

1706 Terbutaline

1707 Terfenadine

1708 Teriparatide

1709 Terlipressin

1710 Terodiline

1711 Teropterin

1712 Testolactone

1713 Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram

1714 Tetanus antitoxin

1715 Tetanus toxoid

1716 Tetanus vaccine

1717 Tetrabenazine

1718 Tetracosactrin

1719 Tetracycline

1720 Tetraethylammonium

1721 Tetrahydrocannabinol

1722 Tetrazepam

1723 Tetroxoprim

1724 Thalidomide

1725 Thenyldiamine

1726 Theophylline; except in liquid form for oral use in medicines containing 2% or less

1727 Thevetia peruviana

1728 Thevetin

1729 Thiambutosine

1730 Thiazosulfone

1731 Thiethylperazine

1732 Thioacetazone

1733 Thiocarlide

1734 Thioguanine

1735 Thiomesterone

1736 Thiopentone

1737 Thiopropazate

1738 Thioproperazine

1739 Thioridazine

1740 Thiotepa

1741 Thiothixene

1742 Thiouracil

1743 Thiourea; except in medicines containing 0.1% or less

1744 Thymoxamine

1745 Thyroid

1746 Thyrotrophin

1747 Thyrotrophin-releasing factor

1748 Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram

1749 Tiagabine

1750 Tiaprofenic acid

1751 Tiaramide

1752 Tibolone

1753 Ticarcillin

1754 Ticlopidine

1755 Tiemonium

1756 Tienilic acid

1757 Tigecycline

1758 Tigloidine

1759 Tiletamine

1760 Tilidine

1761 Tiludronic acid

1762 Timolol

1763 Tinidazole

1764 Tinzaparin

1765 Tioconazole; except when specified elsewhere in this schedule

1766 Tiotropium

1767 Tipepidine

1768 Tiprinavir

1769 Tirilazad

1770 Tirofiban

1771 Tobramycin

1772 Tocainide

1773 Tocilizumab

1774 Tolazamide

1775 Tolazoline

1776 Tolbutamide

1777 Tolcapone

1778 Tolfenamic acid

1779 Tolmetin

1780 Tolonium

1781 Tolpropamine

1782 Tolrestat

1783 Tolterodine

1784 Topiramate

1785 Topotecan

1786 Torasemide

1787 Toremifene

1788 Toxoids; for injection

1789 Tramadol

1790 Trandolapril

1791 Tranexamic acid

1792 Tranylcypromine

1793 Trastuzumab

1794 Travoprost

1795 Trazodone

1796 Trenbolone

1797 Treosulphan

1798 Treprostinil

1799 Trestolone

1800 Tretamine

1801 Tretinoin

1802 Triacetyloleandomycin

1803 Triamcinolone; except when specified elsewhere in this schedule

1804 Triamterene

1805 Triaziquone

1806 Triazolam

1807 Trichlormethiazide

1808 Trichloroacetic acid; except for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts

1809 Trichloroethylene

1810 Trichodesma africana; at all strengths

1811 Triclofos

1812 Tricyclamol

1813 Tridihexethyl

1814 Trifluoperazine

1815 Trifluperidol

1816 Triflupromazine

1817 Trimeprazine; except when specified elsewhere in this schedule

1818 Trimetaphan

1819 Trimethoprim

1820 Trimipramine

1821 Trimustine

1822 Trinitrophenol

1823 Trioxysalen

1824 Triparanol; at all strengths

1825 Triple antigen vaccine

1826 Triprolidine; except when specified elsewhere in this schedule

1827 Triptorelin

1828 Troglitazone

1829 Trometamol; for injection in medicines containing more than 3%

1830 Tropicamide; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

1831 Tropisetron

1832 Trovafloxacin

1833 Troxidone

1834 Tryptophan; in medicines containing more than 100 milligrams per recommended daily dose except in parenteral nutrition replacement preparations

1835 Tuberculosis vaccine

1836 Tubocurarine

1837 Tulobuterol

1838 Typhoid vaccine

1839 Unoprostone

1840 Uracil

1841 Urapidil

1842 Urethane

1843 Urofollitropin

1844 Urokinase

1845 Ursodeoxycholic acid

1846 Ustekinumab

1847 Vaccines; except when specified elsewhere in this schedule

1848 Vaccinia virus vaccine

1849 Valaciclovir

1850 Valdecoxib

1851 Valganciclovir

1852 Valnoctamide

1853 Valproic acid

1854 Valsartan

1855 Vancomycin

1856 Vardenafil and its structural analogues

1857 Varenicline

1858 Varicella (chickenpox) vaccine

1859 Vasopressin

1860 Vecuronium

1861 Venlafaxine

1862 Verapamil

1863 Veratrum spp.

1864 Vernakalant

1865 Verteporfin

1866 Vidarabine

1867 Vigabatrin

1868 Vildagliptin

1869 Viloxazine

1870 Vinblastine

1871 Vincamine

1872 Vincristine

1873 Vindesine

1874 Vinflunine

1875 Vinorelbine

1876 Vinyl ether

1877 Virginiamycin

1878 Visnadine

1879 Vitamin A; for internal use in medicines containing more than 3 milligrams of retinol equivalents per recommended daily dose except in parenteral nutrition replacement preparations; for external use in medicines containing more than 1%

1880 Vitamin D; for internal use in medicines containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations

1881 Voriconazole

1882 Warfarin

1883 Xamoterol

1884 Xanthinol nicotinate

1885 Ximelagatran

1886 Xipamide

1887 Yellow fever vaccine

1888 Yohimbine

1889 Zafirlukast

1890 Zalcitabine

1891 Zaleplon

1892 Zanamivir

1893 Zidovudine

1894 Zimeldine

1895 Zinc; for internal use in medicines containing more than 25 milligrams 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 and that are sold in the manufacturer'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 in parenteral nutrition replacement preparations

1896 Ziprasidone

1897 Zoledronic acid

1898 Zolmitriptan; except when specified elsewhere in this schedule

1899 Zolpidem

1900 Zonisamide

1901 Zopiclone

1902 Zoxazolamine

1903 Zuclopenthixol

Part 2
Restricted medicines

1 Adrenaline; in medicines containing 1% or less and more than 0.02%

2 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 and that are sold in the manufacturer's original pack

3 Aminophylline; for oral use in liquid form in medicines containing 2% or less

4 Amorolfine; for external use in medicines containing more than 0.25%

5 Aspirin; in slow-release forms; in enteric coated forms containing more than 300 milligrams per dose form; except when specified elsewhere in this schedule

6 Azatadine; for oral use in adults and children over 2 years of age

7 Azelastine; in medicines for ophthalmic use containing 0.05% or less

8 Brompheniramine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

9 Buclizine; for oral use

10 Butoconazole; for vaginal use

11 Chloramphenicol; for ophthalmic use; except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

12 Chlorbutol; in medicines containing more than 5%

13 Chlorpheniramine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

14 Ciclopirox; for external use in medicines containing more than 2%

15 Cimetidine; in medicines that have received the consent of the Minister or the Director-General to their distribution as restricted medicines and that are sold in the manufacturer's original pack containing not more than 14 days' supply

16 Clemastine; for oral use

17 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 and that are sold in the manufacturer's original pack

18 Clotrimazole; for vaginal use

19 Codeine; in medicines for oral use containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, 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, for use as an analgesic and when sold in a pack of not more than 5 days' supply, approved by the Minister or the Director-General for distribution as a restricted medicine

20 Cyclizine; for oral use

21 Cyproheptadine; for oral use

22 Dexchlorpheniramine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

23 Di-iodohydroxy quinoline; for vaginal use

24 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

25 Dimenhydrinate; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

26 Dimethindene; for oral use

27 Diphenhydramine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

28 Dithranol

29 Doxylamine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

30 Econazole; for vaginal use

31 Erythrityl tetranitrate

32 Famciclovir; in tablets containing 500 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

33 Flavoxate

34 Fluconazole; for oral use in medicines that have received the consent of the Minister or the Director-General to their distribution as restricted medicines and that are sold in the manufacturer's original pack containing 150 milligrams or less as a single dose for the treatment of vaginal candidiasis

35 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

36 Glucagon; except in medicines containing 100 micrograms or less per litre or per kilogram

37 Glyceryl trinitrate; for oral or sublingual use; for rectal use

38 Glycopyrronium; except for injection

39 Guaiphenesin; for oral use in modified-release form with a maximum recommended daily dose of not more than 2.4 grams sold in a pack containing more than 5 days' supply but not more than 30 days' supply approved by the Minister or the Director-General for distribution as a restricted medicine

40 Haemophilus influenzae vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

41 Hydrocortisone and hydrocortisone acetate but no other esters of hyrocortisone; 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 antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; in rectal medicines containing 1% or less but more than 0.5% by weight of hydrocortisone 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

42 Hyoscine butylbromide; for oral use in medicines containing not more than 10 milligrams per dose form and in packs containing not more than 20 tablets or capsules

43 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 distribution as restricted medicines and that are sold in the manufacturer's original pack labelled for use by adults and children over 12 years of age

44 Inositol nicotinate

45 Isoconazole; for vaginal use

46 Ketoprofen; in solid dose form containing 25 milligrams or less per dose form in packs of not more than 30 capsules or tablets

47 Lansoprazole; in tablets or capsules containing 15 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

48 Levonorgestrel; in medicines for use as emergency post-coital contraception when in packs containing not more than 1.5 milligrams except when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health

49 Macrogols; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures

50 Malathion; for external use in medicines containing more than 2%

51 Mannityl hexanitrate

52 Mepyramine; for oral use in medicines for adults and children over 2 years of age

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 Nicotinic acid except nicotinamide; in medicines containing 250 milligrams or less but more than 100 milligrams per dose form

57 Nicotinyl alcohol; in medicines containing more than 100 milligrams per dose form

58 Nystatin; for the treatment of oral candidiasis; for vaginal use

59 Omeprazole; in tablets or capsules containing 20 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

60 Orlistat; in medicines for weight control containing 120 milligrams or less per dose form

61 Oxiconazole; for vaginal use

62 Pantoprazole; in tablets or capsules containing 20 milligrams or less of pantoprazole when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

63 Pheniramine; for oral use in medicines for adults and children over 2 years of age

64 Pneumococcal vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

65 Podophyllotoxin; for external use for the treatment of warts other than anogenital 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 kilogram

66 Podophyllum emodi; 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

67 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

68 Prochlorperazine; in packs containing not more than 10 tablets or capsules for the treatment of nausea associated with migraine

69 Promethazine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

70 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

71 Salicylic acid; except in medicines for dermal use containing 40% or less

72 Santonin

73 Sodium phosphate; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures

74 Sodium picosulphate; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures

75 Staphyloccocus aureus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

76 Stramonium; for oral use in liquid form; in solid dose form in medicines containing more than 0.3 milligrams per dose or more than 1.2 milligrams per recommended daily dose

77 Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

78 Sulfacetamide; for ophthalmic use in medicines containing 10% or less

79 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

80 Theophylline; in liquid form for oral use in medicines containing 2% or less

81 Tioconazole; for vaginal use

82 Triamcinolone; for buccal use in medicines containing 0.1% or less of triamcinolone acetonide and in pack sizes of 5 grams or less

83 Trimeprazine; for oral use in adults and children over 2 years of age; except when specified elsewhere in this schedule

84 Triprolidine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

85 Zolmitriptan; in a pre-filled nasal spray device containing not more than 5 milligrams 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

1 8-hydroxyquinoline and its non-halogenated derivatives; in medicines containing more than 1% of such substances

2 Acetic acid and preparations containing more than 80% of acetic acid (CH₃COOH); excluding its salts and derivatives

3 Acetylcysteine; for oral use in medicines containing more than 1 gram per recommended daily dose

4 Aciclovir; for external use for the treatment of herpes labialis except in medicines containing 5% or less and in tubes containing 10 grams or less

5 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

6 Aloes; for internal use; except when obtained solely from the mucilaginous gel of the leaf

7 Aloin

8 Aloxiprin

9 Amethocaine; for external use in medicines containing 10% or less and more than 2%

10 Amorolfine; for external use in medicines containing 0.25% or less except in medicines for tinea pedis only

11 Antazoline; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

12 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 milligrams 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 belladonna

13 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 recommended daily dose 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; 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

14 Azelaic acid; for dermal use

15 Azelastine; for nasal use

16 Beclomethasone; 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 when the maximum recommended daily dose is no greater than 400 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine

17 Benzocaine; in preparations for topical use, other than eye drops, containing 10% or less of total anaesthetic substances except in dermal preparations containing 2% or less of total anaesthetic substances; in divided preparations containing 200 milligrams or less of total anaesthetic substances per dosage unit except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit

18 Benzoyl peroxide; for external use in medicines containing more than 5% and not more than 10%

19 Benzydamine; for external use except for dermal use

20 Bephenium

21 Bifonazole; for dermal use except in medicines for tinea pedis only or in shampoos containing 1% or less

22 Bisacodyl

23 Bromhexine

24 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 therapeutically active ingredients either when in the bedtime dose of a day/night pack containing brompheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

25 Budesonide; 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 and when the maximum recommended daily dose is no greater than 400 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine

26 Carbetapentane; in medicines containing more than 0.5%

27 Carbocisteine

28 Cetirizine; for oral use

29 Chlophedianol

30 Chlorbutol; in medicines containing 5% or less and more than 0.5%

31 Chloroform; in medicines other than for anaesthesia containing more than 0.5%

32 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 therapeutically active ingredients either when in the bedtime dose of a day/night pack containing chlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

33 Ciclopirox; for external use in medicines containing 2% or less except in medicines for tinea pedis only

34 Cinchocaine; for external use in medicines containing 0.5% or less

35 Cinnamedrine

36 Clotrimazole; for external use except in medicines for tinea pedis only

37 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 substance 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

38 Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, 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, for the treatment of the symptoms of cough and cold and when sold in a pack of not more than 6 days' supply, approved by the Minister or the Director-General for distribution as a pharmacy-only medicine

39 Colocynth

40 Creosote; in medicines containing more than 10%

41 Cresols; in medicines containing more than 3%

42 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 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

43 Delphinium staphisagria; in medicines containing more than 0.2%

44 Desloratadine; for oral use

45 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 therapeutically 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

46 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 containing 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

47 Dibrompropamidine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

48 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

49 Diphenoxylate; in liquid form containing in each millilitre not more than 0.5 milligrams of diphenoxylate calculated as base and not less than 5 micrograms of Atropine sulphate; in solid dose form containing not more than 2.5 milligrams of diphenoxylate calculated as base and not less than 5 micrograms of atropine sulphate

50 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 children over 2 years of age except when sold at a transport terminal or aboard a ship or aircraft

51 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 therapeutically active ingredients either when in the bedtime dose of a day/night pack containing diphenhydramine or when at least 1 of the other active ingredients 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 transport terminal or aboard a ship or aircraft

52 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 containing doxylamine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

53 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 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

54 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 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

55 Econazole; for dermal use except in medicines for tinea pedis only

56 Etafedrine

57 Ether; in medicines containing more than 10%

58 Etofenamate; for external use

59 Famotidine; in medicines that have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's original pack containing not more than 14 days' supply

60 Felbinac; for external use

61 Fexofenadine; for oral use except when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride when sold in a pack approved by the Minister or the Director-General for distribution as a general sales medicine

62 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 kilogram 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

63 Flurbiprofen; in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit

64 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 when the maximum recommended daily dose is no greater than 200 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine

65 Folic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose

66 Folinic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose

67 Formaldehyde; in medicines containing more than 5%

68 Gelsemium sempervirens; except in medicines containing 1 milligram or less per litre or per kilogram

69 Glutaraldehyde

70 Hexachlorophane; in medicines containing 3% or less but more than 0.75%

71 Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 0.5% or less by weight of hydrocortisone 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

72 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

73 Hydroquinone; for external use in medicines containing 2% or less except in hair preparations containing 1% or less

74 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 medicines 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

75 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 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

76 Hyoscyamus niger; 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 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 containing 30 micrograms or less of total solanaceous alkaloids

77 Ibuprofen; for oral use in liquid form in packs containing not more than 4 grams in medicines that have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's original pack; for oral use in solid dose form containing not more than 200 milligrams per dose form and with a recommended daily dose of not more than 1.2 grams and in packs containing not more than 100 dose units and when in medicines that have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's original pack; except in packs containing 200 milligrams or less per oral solid dose form and not more than 25 dose units per pack in medicines that have received the consent of the Minister or the Director-General to their distribution as general sale medicines and that are sold in the manufacturer's original pack

78 Indanazoline

79 Indomethacin; for external use in medicines containing 1% or less; except in medicines containing 1 milligram or less per litre or per kilogram

80 Iodine; for external use in medicines containing more than 2.5%; for internal use in medicines containing 300 micrograms or more per recommended daily dose

81 Ipecacuanha; in medicines containing 0.2% or less of emetine and 40 micrograms or more of ipecacuanha alkaloids per recommended dose for the treatment of the symptoms of cough and cold in children aged 6–12 years

82 Ipomoea

83 Ipratropium; for nasal use

84 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 parenteral nutrition replacement preparations

85 Isoconazole; for dermal use

86 Isopropamide; for dermal use in preparations containing 2% or less

87 Jalap resin

88 Ketoconazole; for dermal use except in medicines for tinea pedis only or in medicines for treatment of the scalp containing 1% or less

89 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

90 Leucovorin; in medicines containing more than 500 micrograms per recommended daily dose

91 Levocabastine; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

92 Levocetirizine; for oral use

93 Lignocaine; for urethral use; for external use in medicines containing 10% or less and more than 2%

94 Lindane; for external use in medicines containing 2% or less

95 Lithium; for dermal use in medicines containing 1% or less but more than 0.01%; except when present as an excipient in dermal medicines containing 0.25% or less

96 Lobelia inflata; except in medicines for smoking or burning

97 Lobeline; except when in medicines for smoking or burning

98 Lodoxamide; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

99 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

100 Loratadine; for oral use

101 Mebendazole

102 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 terminal or aboard a ship or aircraft

103 Mefenamic acid; in solid dose form in packs containing not more than 30 tablets or capsules for the treatment of dysmenorrhoea

104 Mepyramine; for dermal use

105 Mercuric oxide; for ophthalmic use

106 Mercury; for external use in medicines containing 0.5% or less

107 Methoxamine; for external use in medicines containing more than 1%

108 Methoxyphenamine

109 Methylephedrine

110 Miconazole; for external use except in medicines for tinea pedis only

111 Minoxidil; for dermal use in medicines containing 5% or less

112 Mometasone; 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 and when the maximum recommended daily dose is no greater than 200 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine

113 Morphine; 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 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

114 Naphazoline; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

115 Naproxen; in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules

116 Niclosamide

117 Nicotine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist, or psychologist

118 Nizatidine; in medicines that have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's original pack containing not more than 14 days' supply

119 Noscapine

120 Nystatin; for dermal use

121 Omeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less, with a maximum daily dose of 20 milligrams in a pack size of up to 14 dosage units, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine

122 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 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

123 Oxetacaine; for internal use

124 Oxiconazole; for dermal use except in medicines for tinea pedis only

125 Oxymetazoline; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

126 Papaverine; except for injection

127 Paracetamol; in liquid form; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams; in slow-release forms containing 665 milligrams or less and more than 500 milligrams; in powder form containing not more than 1 gram per sachet and more than 10 grams per pack

128 Paraformaldehyde; in medicines containing more than 5%

129 Penciclovir; for external use for the treatment of herpes labialis

130 Phedrazine

131 Phenazone; for external use

132 Pheniramine; for ophthalmic use except when sold in practice by an optometrist 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 decongestant

133 Phenol; in medicines other than for injection containing more than 3%

134 Phenylephrine; for nasal use in medicines containing more than 1%; for ophthalmic 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

135 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 distribution as a pharmacy-only medicine

136 Piperazine

137 Podophyllotoxin; for external use for the treatment of warts other than anogenital warts in medicines containing 0.5% or less; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram

138 Podophyllum emodi; 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 kilogram

139 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 kilogram

140 Potassium; for internal use: in slow-release or enteric coated forms; 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

141 Potassium chlorate; except in medicines containing 10% or less

142 Prilocaine; for dermal use in medicines containing 10% or less of local anaesthetic substances

143 Procyclidine; for dermal use in medicines containing 5% or less

144 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 containing promethazine or when at least 1 of the other active ingredients 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 transport terminal or aboard a ship or aircraft

145 Propamidine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

146 Pseudoephedrine; in medicines for oral use containing not more than 60 milligrams of pseudoephedrine per solid dosage unit or per dose of liquid, and containing either a single ingredient or when combined with 1 or more active ingredients, when sold in a pack containing not more than 1.8 grams of pseudoephedrine, approved by the Minister or the Director-General for distribution as a pharmacy-only medicine

147 Pyrantel

148 Pyrethrins; in medicines containing more than 10%

149 Pyrithione zinc; except in medicines for treatment of the scalp containing 2% or less

150 Ranitidine; in medicines that have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's original pack containing not more than 14 days' supply; except in medicines containing 150 milligrams or less per dose unit that have received the consent of the Minister or the Director-General to their distribution as general sale medicines and that are sold in the manufacturer's original pack containing not more than 7 days' supply

151 Salicylamide

152 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

153 Sennosides

154 Silver; except in oral solutions containing 0.3% or less or other medicines containing 1% or less

155 Silver sulfadiazine; for external use in pack sizes of 50 grams or less

156 Sodium cromoglycate; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

157 Sodium nitrite; except for use as an excipient

158 Sodium picosulphate; in oral laxative preparations

159 Squill; in medicines containing more than 1%

160 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 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

161 Sulconazole; for dermal use

162 Sulfadiazine, silver; for external use in pack sizes of 50 grams or less

163 Terbinafine; for dermal use except in medicines for tinea pedis only

164 Tetrachloroethylene

165 Tetrahydrozoline; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

166 Thiabendazole

167 Tioconazole; for dermal use except in medicines for tinea pedis only

168 Tramazoline

169 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

170 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 containing trimeprazine or when at least 1 of the other therapeutically active ingredients is a sympathomimetic decongestant

171 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 containing triprolidine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

172 Tuaminoheptane

173 Tymazoline

174 Xylenols; in medicines containing more than 3%

175 Xylometazoline; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

176 Zinc chloride; for dermal use in medicines containing more than 5%

Rebecca Kitteridge,
Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations, which are made under the Medicines Act 1981, amend the Medicines Regulations 1984 (the principal regulations). The majority of the regulations come into force on 1 August 2011, with the remainder coming into force on 1 December 2011.

The most significant amendments to the principal regulations relate to the following:

advertising and labelling requirements for medicines:
prescribing rights and requirements:
dispensing requirements:
data sheets:
products that are not medicines or related products:
the sale of medicines by vending machine.

The regulations also substitute a new Schedule 1 of the principal regulations, which lists all classified medicines.

Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notification in Gazette: 14 July 2011.

These regulations are administered by the Ministry of Health.

Medicines Amendment Regulations 2011

Medicines Amendment Regulations 2011

Medicines Amendment Regulations 2011

Order in Council

Contents

Regulations

1 Title

2 Commencement

3 Principal regulations amended

4 Interpretation

5 Regulation 6 revoked

6 New regulation 8 substituted

“8 Advertisements for medicines

7 Regulation 11 substituted

“11 Advertisements intended for health professions

8 New regulations 13 to 16 substituted

“13 Labelling of medicines

“14 Labelling of related products

“15 Exemptions from regulations 13 and 14

“16 Principal display panel

9 Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines

10 Regulation 20 revoked

11 New regulation 22 substituted

“22 Warning statements for medicines and related products

12 Labels on containers of medicines sold by authorised prescribers or pharmacists

13 Safety containers

14 New regulation 39 substituted

“39 Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines

15 New regulation 39A inserted

“39A Limit on period of supply of prescription medicines

16 Prescriptions to comply with regulations

17 Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing

18 Form of prescription

19 Dispensing of prescription medicines

20 New regulation 43 substituted

“43 Director-General may waive certain requirements

21 Prescriptions for prescription medicines not required in certain cases

22 New regulations 51 to 53 substituted

“51 Interpretation

“52 Approval of data sheets for new medicines

“53 Approval of data sheets for changed medicines

23 New regulation 58A inserted

“58A Substances that are not medicines or related products for purposes of Act

24 New regulation 59 substituted

“59 General sale medicines may be sold by vending machine

25 Offences

26 New regulation 65A inserted

“65A Transitional provision arising from enactment of Medicines Amendment Regulations 2011

27 New Schedule 1 substituted

28 Form 1B of Schedule 2 amended

29 Schedule 3 revoked

30 Amendments to Misuse of Drugs Regulations 1977

ScheduleNew Schedule 1 substituted

Schedule 1Prescription, restricted, and pharmacy-only medicines

Part 1Prescription medicines

Part 2Restricted medicines

Part 3Pharmacy-only medicines

Explanatory note

Medicines Amendment Regulations 2011

Schedule
New Schedule 1 substituted

Schedule 1
Prescription, restricted, and pharmacy-only medicines

Part 1
Prescription medicines

Part 2
Restricted medicines

Part 3
Pharmacy-only medicines