All medicines and classes of medicines specified in Part 1 of Schedule 1 are hereby declared to be prescription medicines.

All medicines and classes of medicines specified in Part 2 of Schedule 1 are hereby declared to be restricted medicines.

Subject to subclause (4), all medicines and classes of medicines specified in Part 3 of Schedule 1 are hereby declared to be pharmacy-only medicines.

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

Any medicine or related product, other than a medicine or related product for which a standard is otherwise prescribed in these regulations, shall, where it is described as conforming to a monograph in a specified publication, conform to the description and tests set out in that publication for that medicine or related product.

Every medicine, related product, or cosmetic used or represented as suitable for application into the eye shall conform to the tests for sterility set out in a specified publication.

Every medicine, related product, or cosmetic that is a dusting powder for use on the skin of a baby, or on any inflamed, abraded, or broken skin, shall be free of pathogenic organisms.

No medicine, related product, cosmetic, or dentifrice intended for sale shall contain or have attached to it or enclosed with it any extraneous thing that is harmful, dangerous, or offensive.

A surgical dressing that is described as conforming to a monograph in a specified publication shall conform to the description and tests set out in that publication for that surgical dressing.

A medical device that is described as conforming to a particular description shall conform to that description.

The minimum quality standard imposed by Part 1 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 applies to a CBD product as if it were both a cannabis-based ingredient and a medicinal cannabis product under those regulations.

However, the minimum quality standard does not apply to a CBD product that is imported by—

Subclause (4) applies to a CBD product of a type that, at the commencement of this regulation, has been imported into New Zealand by the holder of a licence issued under the Medicines Act 1981.

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

The minimum quality standard does not apply to a CBD product if—

In this regulation, CBD product has the meaning given by section 2A of the Misuse of Drugs Act 1975.

Where any liquid medicine in respect of which a standard is prescribed by any of the provisions of these regulations is to be supplied by a pharmacist pursuant to a prescription issued for a particular patient, the pharmacist may add a compatible diluent to the medicine if he is satisfied that—

No advertisement relating to any medicine, related product, or medical device shall contain a statement to the effect that an advisory or technical committee established under section 8 of the Act, or any member of such a committee, or any officer in the service of the Government, has approved, or has refrained from disapproving, the advertisement or any of the claims or statements made in it.

Every advertisement for a prescription medicine must include—

Every advertisement for a restricted medicine must include—

Every advertisement for a pharmacy-only medicine or a general sale medicine must include—

Every advertisement for a medicine to be supplied by mail order, direct marketing, or via the Internet must—

A statement required by this regulation must be—

A statement that is required by this regulation may be both clearly printed and clearly spoken.

This regulation does not apply to—

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—

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

Every advertisement for a related product, other than a label or a price list, shall include a statement of the uses of the related product.

Every advertisement that refers to an active ingredient of a related product by name shall state the appropriate designation of the ingredient.

Every advertisement for a medical device, other than a label or a price list, shall include, where appropriate, the following:

This regulation applies—

Every advertisement for a medicine must—

Nothing in subclause (2)(a)(iii) or (vi) to (xi) applies to an advertisement that—

Every advertisement for a related product or medical device must include—

No person shall sell any medicine or related product in a container if the container—

No person shall sell a package containing a single container of any medicine or related product unless that package is labelled in a manner similar to that in which the container is labelled.

No person shall sell any medicine in a poison bottle bearing any label that obscures any flutings, ribs, nettings, points, embossed words, or similar markings on the bottle.

No person shall sell any medical device that does not bear the name of the manufacturer of the medical device or the name of the manufacturer’s distributor in New Zealand.

Notwithstanding anything in the foregoing provisions of this regulation, the Director-General may, by notice in writing to the manufacturer or importer of any medicine, exempt from the labelling requirements of these regulations the sale of that medicine in a container of a specified type.

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

For the purposes of subclause (1)(p),—

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.

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—

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.

Every container of a medicine that is prepared for injection into the human body and that contains an antiseptic or preservative must be labelled with a statement of the nature and amount of the antiseptic or preservative.

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

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.

This regulation is subject to regulations 15 and 23.

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

For the purposes of subclause (1)(k),—

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—

Nothing in regulation 13 or 14 applies to a strip of containers that—

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.

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.

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.

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.

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.

The principal display panel of the label of a medicine must contain—

Subclause (1) is subject to regulation 23.

The principal display panel of the label of a related product must contain—

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.

Subclause (4) is subject to regulation 19.

Subject to subclause (4), every label that is required by these regulations to be borne on a container shall—

The lettering of the words required by these regulations shall be clear, distinct, and legible, with no decoration, embellishment, or distortion that could interfere with the legibility of the words.

Every label that is required by these regulations to appear on a container shall, if the medicine or related product is sold otherwise than in a container, appear on the medicine or related product.

It shall be sufficient compliance with subclause (1) if the particulars required by paragraphs (d) and (e) of regulation 13(1) are embossed conspicuously on the container of the medicine.

A minimum size of lettering used on labels that is prescribed by these regulations refers to the height of capital letters, or lower case letters with an ascender or descender, in the typeface used.

Subject to subclause (6) and except as otherwise expressly permitted by any of the provisions of these regulations, the lettering of words required by these regulations to appear on labels shall be not less than 1.5 millimetres in height.

Where words are required by these regulations to appear on labels in letters of a specified size, and the container to be labelled is so small as to prevent the use of letters of that size, letters of a smaller size may be used if they are of the largest size practicable in the circumstances and are in any event no smaller than 0.75 millimetres.

Where a label on a container is required by these regulations to bear—

the words or acronym, as the case may require, shall be placed prominently and legibly on the label.

The quantitative declaration of every vitamin in any medicine or related product shall be expressed in milligrams or micrograms.

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.

A warning statement is additional to any other statement or information that is required by these regulations to be shown on a label.

Subclause (1) is subject to regulation 23.

It shall not be necessary to comply with the requirements of regulation 13 or regulation 16(1) or regulation 22 in respect of any label on a container of a medicine that is packed, supplied, or sold by an authorised prescriber or a pharmacist with reference to the needs of a particular patient or (as the case may be) a particular customer, if the label contains the following:

This regulation applies to labels on containers of related products and cosmetics that are intended for dyeing hair and consist of or contain—

Every label to which this regulation applies shall include the following:

No written, pictorial, or other descriptive matter appearing on or attached to or supplied or displayed with any medicine or medical device shall include any comment on, reference to, or explanation of any statement or label required by these regulations to be borne on any medicine or medical device if that comment, reference, or explanation either directly or by implication contradicts, qualifies, or modifies that statement or the contents of that label.

No written, pictorial, or other descriptive matter supplied or displayed with any medicine or medical device shall include any false or misleading statement, word, brand, picture, or mark purporting to indicate the nature, suitability, quantity, quality, strength, purity, composition, weight, origin, age, effects, or proportion of the medicine or medical device or any ingredients of the medicine or components of the medical device.

Every person who—

shall, at all times while so engaged or employed, maintain his clothing and his person in a state of cleanliness.

No person who is engaged or employed in the sale of any medicine, related product, or cosmetic, or in the manufacture, packing, labelling, storage, or supply of any medicine, related product, or cosmetic for sale, shall do any act or make any default or omission whereby that medicine, related product, or cosmetic becomes or is liable to become contaminated, polluted, or tainted.

No person who is suffering from a communicable disease (within the meaning of the Health Act 1956), or is a carrier (within the meaning of that Act), or is suffering from a condition causing a discharge of pus or exudate, shall engage or be employed in the sale, or the manufacture, packing, labelling, storage, or supply, for sale, of—

The Medical Officer of Health may, by notice in writing served on a person who has been in recent contact with any person to whom regulation 27 applies, prohibit the person so served from engaging or being employed in the sale of any medicine, related product, or cosmetic, or the manufacture, packing, labelling, storage, or supply of any medicine, related product, or cosmetic for sale.

Where, in the opinion of the Medical Officer of Health, there is no longer any risk of any medicine, related product, or cosmetic becoming infected by a person on whom any such notice has been served, the Medical Officer of Health shall revoke the notice, and shall notify the person in writing of the revocation.

No person shall—

No person shall use any place or permit any place to be used for or in connection with the sale of any medicine, related product, or cosmetic, or the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale, unless the place complies with the following requirements:

No person shall use any dwellinghouse, or permit any dwellinghouse to be used, for or in connection with the manufacture or packing of any medicine, related product, or cosmetic for sale if the use of the dwellinghouse is likely to result in the contamination of the medicine, related product, or cosmetic, or to affect injuriously its cleanliness.

This regulation shall apply to premises that are, in the opinion of the Medical Officer of Health, by reason of their construction or disrepair, or by reason of the use or character of any neighbouring premises, in such a condition that any medicine, related product, or cosmetic in the first premises may be exposed to contamination or taint, or may deteriorate or become dirty.

Subject to subclause (6), the Medical Officer of Health may serve a notice in writing on any owner or occupier of any premises to which this regulation applies, prohibiting the use of the premises for or in connection with the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale.

Every such notice shall—

Subject to subclause (6), where in the opinion of the Medical Officer of Health the reason for which any such notice was served has ceased to exist, he shall revoke the notice, and shall notify in writing the owner or occupier of the premises concerned, and every other person on whom a copy of the notice has been served, of the revocation.

While any such notice remains in force,—

No notice shall be served by a Medical Officer of Health pursuant to subclause (2) or subclause (4) unless approval to serve the notice has first been obtained from the Director-General.

Every person in possession or control of any medicine, related product, or cosmetic for sale, or of any container or appliance used for or in connection with the sale of any medicine, related product, or cosmetic, or the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale, shall at all times—

Every person in possession of any medicine, related product, or cosmetic for sale shall at all times store and keep it packed in such manner as to minimise its deterioration, and shall comply with all requirements for storage stated on the label or contained in a specified publication in respect of that medicine, related product, or cosmetic.

No person shall use, or permit to be used, any container, appliance, or vehicle for or in connection with the manufacture, storage, packing, or supply of any medicine, related product, or cosmetic for sale unless that container, appliance, or vehicle is constructed of such material and in such manner as to allow for easy cleaning, and is kept clean.

No person shall use, or permit to be used, in the supply of any medicine, related product, or cosmetic for sale any container, appliance, or vehicle that is also used for the carriage of any matter that endangers or could endanger the cleanliness or freedom from contamination of the medicine, related product, or cosmetic.

No person shall use, or permit to be used, for the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale, any container that has been used for any purpose that may contaminate or taint the medicine, related product, or cosmetic, unless the container has been thoroughly cleaned.

Except as otherwise provided in these regulations, no person shall, in the course of the manufacture, storage, packing, or supply of any medicine, related product, or cosmetic for sale, keep, carry, spread, or use, or permit to be kept, carried, spread, or used, any toxic or noxious substance so as to expose the medicine, related product, or cosmetic to the risk of contamination by that substance at any time.

A person must not pack, store, or sell a prescription medicine, restricted medicine, or pharmacy-only medicine in a container made of paper; but nothing in this subclause prevents the person from packing, storing, or selling the medicine in a container made of cardboard.

No person shall use, or permit to be used, in the storage, packing, or supply of any medicine, related product, or cosmetic for sale, a container that yields, or could yield, to its contents a toxic, injurious, or tainting substance.

Every container used in the packing of a medicine and made of glass or plastic shall comply with the tests for that type of container (if any) specified in the United States Pharmacopeia.

Every container used in the packing of a medicine and made of metal shall be impermeable to moisture.

Every container used in the packing of a medicine and made of metal or plastic shall be made of a material that will not adversely react with the contents of the container.

Except as provided in subclause (8), no person shall store, pack, or sell in a container of a capacity of not less than 15 millilitres and not more than 2.5 litres any medicine, related product, or cosmetic that—

unless the container is a poison bottle.

It shall not be necessary to pack in a poison bottle any medicine, related product, or cosmetic to which subclause (7) applies if that medicine, related product, or cosmetic is—

No person shall have in his possession or charge (whether for the purposes of sale or otherwise) in an open container, any medicine, related product, or cosmetic that has poisonous properties, except while the container is being filled or the medicine, related product, or cosmetic in the container is being used.

No person in possession or charge of any medicine, related product, or cosmetic shall keep it, whether temporarily or permanently, in any bottle, jar, can, tinplate container, culinary utensil, or other container of a type that—

No person shall store or keep for ready use any medicine, related product, or cosmetic in such manner that a food or drink may be contaminated by the escape or leakage of the medicine, related product, or cosmetic, or by the release of vapours from the medicine, related product, or cosmetic.

No person shall sell any tablet, or other single item in solid form that is intended to be taken orally, being or comprising a medicine or belonging to a class of medicines to which this regulation applies, unless the tablet or item is enclosed in a safety container.

Subclause (1) shall not apply—

This regulation applies to the following medicines:

aspirin, and its salts; and medicines containing aspirin or its salts:

iron, in medicines for human use containing more than 24 milligrams of elemental iron per dose:

paracetamol; and medicines containing paracetamol.

This regulation applies to the following classes of medicines:

barbiturates:

phenothiazine, and derivatives of phenothiazine and their salts, except dimethothiazine, methdilazine, promethazine, and trimeprazine, and their salts and molecular compounds:

tricyclic, tetracyclic, and analogous antidepressants.

Every medicine imported into, or packed or consigned for transport in, New Zealand shall be securely packed in a container that is sufficiently strong to withstand, and to protect the contents from damage arising in, the ordinary course of transport.

No person shall import into, or transport or cause to be transported in, New Zealand any medicine that is not packed in compliance with subclause (1).

Every related product packed or consigned for transport in New Zealand shall be securely packed in a container that is sufficiently strong to withstand, and to protect the contents from damage arising in, the ordinary course of transport.

No person shall transport or cause to be transported in New Zealand any related product that is not packed in compliance with subclause (3).

A person must not import into New Zealand any CBD product (regardless of whether the ingredients are made from cannabis) for their personal use by any method of import (such as overseas courier or post), except by physically carrying it on the person when entering New Zealand.

An authorised prescriber (including a designated prescriber) may only prescribe a prescription medicine if the authorised prescriber—

An authorised prescriber who is a designated prescriber may only prescribe a prescription medicine if—

A veterinarian may only prescribe a prescription medicine that is for the treatment of an animal under the veterinarian’s care.

Subclause (1) does not apply to an authorised prescriber who is acting in the course of his or her employment by the Crown.

An authorised prescriber may not on any occasion prescribe for any patient a quantity of any prescription medicine that exceeds 12 months’ supply.

However, the Director-General may, at his or her discretion, authorise—

Except as provided in regulation 40A, every authorised prescriber or veterinarian who issues a prescription to a person must comply with regulation 41.

Subclause (1) applies to a prescription for any medicine (whether a prescription medicine or not).

Subclause (2) does not prevent the sale by retail, or the supply in circumstances corresponding to retail sale, or the dispensing, of a medicine (other than a prescription medicine) without a prescription.

Where an authorised prescriber or veterinarian finds it necessary to do so, he or she may communicate orally to a pharmacist to whom he or she is known personally (whether in the pharmacist’s presence or by speaking to the pharmacist on the telephone) a prescription relating to a prescription medicine that the authorised prescriber or veterinarian requires urgently.

Within 7 days after a communication made by an authorised prescriber or veterinarian to a pharmacist under subclause (1), the authorised prescriber or veterinarian must issue a prescription in paper or electronic form that confirms the oral communication and forward or transmit the prescription to the pharmacist.

A prescription issued or given under these regulations must be in paper or electronic form.

Every prescription must—

A paper prescription must—

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

Any reference in these regulations that relates to including or recording anything in or on a prescription means, for an electronic prescription, including or recording it in the electronic records for the electronic prescription.

In this regulation, approved system means a system approved by the Director-General by notice in the Gazette.

Except as provided in subclause (2), no person other than an authorised prescriber, veterinarian, pharmacist, pharmacy graduate, a pharmacy technician, a student, or dispensary technician may dispense a prescription medicine.

The following persons may not dispense prescription medicines unless under the direct personal supervision of a pharmacist:

An agent or employee of a veterinarian may, in any particular case, dispense any prescription medicine at the direction of the veterinarian for use in the treatment of any animal under the care of the veterinarian.

Every person dispensing a prescription relating to a prescription medicine must comply with the following requirements:

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—

This regulation is subject to regulation 43.

Despite the requirements in regulations 41 and 42, the Director-General may, at his or her discretion,—

A form of prescription that may be authorised under subclause (1)(a) includes, but is not limited to, an electronic form of prescription.

A prescription medicine may be sold or dispensed otherwise than under a prescription given by a practitioner, registered midwife, veterinarian, or designated prescriber if it is sold to or dispensed for—

Any medical practitioner or other person who is authorised by the Director-General or a Medical Officer of Health in accordance with this regulation to administer or supply, for the purposes of an approved immunisation programme, a vaccine or other prescription medicine may, in carrying out that immunisation programme, administer or supply that prescription medicine otherwise than pursuant to a prescription.

Any medical practitioner or other person who is authorised by the Director-General or a Medical Officer of Health in accordance with this regulation to administer or supply a restricted or pharmacy-only medicine for the purposes of an approved immunisation programme may supply or administer that medicine for those purposes without complying with section 18(1) of the Act.

The Director-General or a Medical Officer of Health may authorise any person for the purposes of subclause (1) or (1A) if that person, following written application, provides documentary evidence satisfying the Director-General or the Medical Officer of Health, as the case may be, that that person—

Subject to subclause (4), any authorisation given by the Director-General or a Medical Officer of Health under subclause (2) shall be valid for a period of 2 years and shall be subject to such conditions as the Director-General or the Medical Officer of Health, as the case may be, thinks fit.

An authorisation given to any person under subclause (2) may be withdrawn at any time before its expiry if the Director-General or a Medical Officer of Health is satisfied that the authorised person has failed to comply with any condition specified by the Director-General or the Medical Officer of Health under subclause (3).

The Director-General or a Medical Officer of Health may authorise a person who meets the requirements of this regulation to—

An authorised person must, at all times while performing the tasks authorised under these regulations, work under the clinical supervision and direction of a suitably qualified health practitioner.

In applying for authorisation, a person must provide evidence to satisfy the Director-General or the Medical Officer of Health, as the case may be,—

The Director-General or the Medical Officer of Health, as the case may be,—

An application to add a vaccine must be made in accordance with subclause (3)(a).

The Director-General or the Medical Officer of Health, as the case may be, may—

An authorisation is valid for a period of 2 years, unless it is revoked earlier under subclause (8).

The Director-General or the Medical Officer of Health, as the case may be, may revoke an authorisation by written notice to the authorised person if satisfied that the authorised person has failed to comply with any condition on their authorisation.

The Medical Officer of Health may require any authorised prescriber to supply information relating to the prescribing, administering, or supplying of any prescription medicines if the Medical Officer of Health has reason to suspect that prescription medicines may have been improperly prescribed, administered, or supplied by the authorised prescriber.

Every requirement to supply information must be in writing, stating the reasons for the Medical Officer of Health’s suspicion.

The information that must be supplied is information justifying the prescription, administering, or supply of the prescription medicines as follows:

An authorised prescriber to whom any such notice is sent must supply the required information in writing to the Medical Officer of Health within 30 days.

An authorised prescriber must not prescribe a prescription medicine that is a gonadotropin-releasing hormone analogue for the purpose of puberty suppression in a person who is a child or adolescent with—

See Part 2 of Schedule 1AA for a transitional provision in respect of this regulation.

No person may export a prescription medicine in the course or for the purpose of retail sale, otherwise than under a prescription given by a practitioner, a registered midwife, or a designated prescriber.

The meaning of retail sale in subclause (1) must be determined by reference to section 5(2) of the Act.

Subclause (1) is intended to limit the sale and supply of prescription medicines pursuant to section 33(b) of the Act.

A person may, in the course of any business carried on by that person, supply a restricted medicine or pharmacy-only medicine if he or she—

The circumstances in which a person may supply a restricted medicine or pharmacy-only medicine under subclause (1) are in addition to the circumstances in which a person may supply a restricted medicine or pharmacy-only medicine under section 18(1)(b) or (c) of the Medicines Act 1981.

Every application for a licence to manufacture, hawk, sell, or pack medicine must—

A licence to undertake an activity referred to in subclause (1) may only be granted in respect of 1 place of business.

Despite subclause (2), the licensing authority may grant a licence that allows for the manufacture of medicine, or a description or class of medicines, at more than 1 place of business if—

Every applicant for a licence under this regulation must provide the licensing authority with the following things if required by the licensing authority under section 51 of the Act:

The licensing authority may, in order to determine if a person to whom section 51(1)(d) of the Act applies has a sufficient knowledge of the obligations of a licensee and of the hazards associated with the medicines to which a licence to manufacture, hawk, sell, or pack medicine relates, require that person to undertake and pass any oral, written, or practical tests that the licensing authority considers reasonably necessary in the particular case.

Every application for a licence to operate a pharmacy must—

A licence to operate a pharmacy may only be granted in respect of 1 place of business.

Every applicant for a licence under this regulation must provide the licensing authority with the following things if required by the licensing authority under section 51 of the Act:

The licensing authority may, in order to determine if a person to whom section 51(1)(d) of the Act applies has a sufficient knowledge of the obligations of a licensee and of the hazards associated with the medicines to which a licence to operate a pharmacy relates, require that person to undertake and pass any oral, written, or practical tests that the licensing authority considers reasonably necessary in the particular case.

A licence to manufacture medicines, to sell medicines by wholesale, to pack medicines, or to operate a pharmacy that is issued under these regulations does not apply to a CBD product (as defined by section 2A of the Misuse of Drugs Act 1975) unless expressly authorised by the licence.

The licence must not be issued, or amended, to expressly authorise its application to the supply of a CBD product unless—

A product is assessed as complying with the minimum quality standard under those regulations if—

The following licences must be in the following forms:

On granting a licence under the Act, the licensing authority may impose such conditions as he thinks fit.

Every application for a licence to manufacture any medicine shall specify which of the following descriptions or classes the medicine comes within or belongs to:

Where an application to manufacture medicines applies to 1 or more medicines or descriptions or classes of medicines, the licensing authority may grant a licence for all the medicines or descriptions or classes of medicines to which the application relates, or for such of the medicines or descriptions or classes of medicines to which the application relates as the licensing authority is satisfied the applicant is qualified to manufacture and capable of manufacturing.

Subject to subclause (2), and without affecting the generality of regulation 46(2), every licence to hawk any prescription medicine, restricted medicine, or pharmacy-only medicine shall be granted subject to the following conditions:

No person shall be granted a licence to hawk any prescription medicines, restricted medicines, or pharmacy-only medicines by retail.

A company or person who is granted a licence to operate a pharmacy must advise the licensing authority as soon as practicable of any change in the details that relate to the application for that licence (including, without limitation, changes in the details of any additional information required by the licensing authority).

A company that is granted a licence to operate a pharmacy under section 55D(2)(a) of the Act must immediately advise the licensing authority if there is a change or are changes in the ownership of the share capital of the company that means that more than 50% of the share capital is no longer owned by a pharmacist or pharmacists.

The requirement imposed by subclause (2) is in addition to the requirement imposed by subclause (1).

Subclause (1A) applies if a licensee ceases to—

If this subclause applies, the licensee must, within 7 days of ceasing to undertake the activity to which the licence relates, surrender that licence to the licensing authority.

The licensing authority, on receiving a licence pursuant to subclause (1A), shall retain the licence for the remainder of the current licence period.

Nothing in this regulation shall prevent a licensee who has surrendered his licence pursuant to subclause (1A) from applying to the licensing authority for restoration of the licence to the licensee at any time during the current licence period.

In any such case, but subject to subclause (5), the licensing authority, on being satisfied that the licensee complies with the requirements of the Act and these regulations relating to the granting of licences, shall restore the licence to the licensee.

Notwithstanding anything in these regulations, it shall not be necessary for any licensee who surrenders his licence to pay a further licence fee on application for restoration of that licence.

The Director-General may issue to any importer, manufacturer, or seller of any medicine, related product, or medical device an order—

The importer, manufacturer, or seller shall, on receipt of an order made under subclause (1), advise the Director-General of the manner and time in which he proposes to comply with the order, and shall give written notice to the Director-General when the order has been complied with.

Notwithstanding anything in subclause (2), the Director-General may issue directions to the recipient of an order made under subclause (1) as to the manner and time in which the order is to be complied with.

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.

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.

On receipt of the proposed data sheet, the Minister may—

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.

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.

On receipt of the proposed revised data sheet, the Director-General may—

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.

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.

This regulation applies to the sale of a medicine if it is—

A person who makes sales to which subclause (1) applies must—

The register must be in 1 or more of the following forms:

The information to be recorded and kept in relation to each sale is—

Before giving to the buyer a medicine to whose sale regulation 54A(1) applies, the person making the sale must record in the Sale of Medicines Register maintained under regulation 54A(2) the information stated in regulation 54A(4).

It is not necessary to comply with subclause (1) in relation to a sale by wholesale if the information stated in regulation 54A(4) can be discovered from the seller’s books and records.

Every person who hawks any prescription medicine, restricted medicine, or pharmacy-only medicine shall keep and maintain a “Hawker’s Medicines” book that records the medicines that he hawks or has in his possession.

Each page of the Hawker’s Medicines book shall—

The particulars in the Hawker’s Medicines book shall be legibly and indelibly entered not later than the ordinary business day next following the day on which the medicine concerned was sold.

Every person to whom subclause (1) applies shall—

Every person who dispenses or supplies any prescription medicine or restricted medicine pursuant to a prescription shall, not later than the ordinary business day next following the day on which the medicine was dispensed or supplied, record that dispensing or supply of the medicine in a “Prescriptions” register, or in such other form, or within such other period of time, as the Director-General may from time to time approve.

The person responsible for a record to which this Part applies must keep it for at least 3 years after it was made (or, if it is kept together with other records, for at least 3 years after the most recent of them was made).

The person must keep the record—

The following classes of substances are not medicines or related products for the purposes of the Act:

The procedures referred to in subclause (1)(e)(iii)(B) are—

This regulation applies in relation to drinking water in a drinking water supply.

Fluoridating agents for use in fluoridating drinking water are not medicines or related products for the purposes of the Act.

The addition of 1 or more fluoridating agents to drinking water does not make the drinking water a medicine or related product for the purposes of the Act.

In this regulation,—

Substances used to terminate a pregnancy are medicines for the purposes of the Act.

Products containing nicotine that are not for oral use are medicines for the purposes of the Act.

To avoid doubt, oral use includes (without limitation) inhalation.

Medications, when used for assisted dying under the End of Life Choice Act 2019, are medicines for the purposes of the Act.

The Director-General may, by notice in the Gazette,—

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

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

The licence fees set out in Schedule 5A are payable for the licences to which they relate.

The amount to be deposited with the Medicines Review Committee pursuant to section 13(2) of the Act shall be $9,000.

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

The fee to accompany any other application made under section 21 of the Act for the Minister’s consent under section 20 of the Act shall be $79,877.

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

The fee to accompany an application made under section 22C(1) of the Act for the Director-General’s compliance decision under section 22C(2) of the Act is $1,730.

The fee to accompany an application made under section 22C(1) of the Act for the Minister’s consent by verification under section 22D of the Act is $42,601.

The fee to accompany an application made under section 23 of the Act for the Minister’s provisional consent shall be $85,202.

The fee to accompany a notice deposited with the Director-General under section 24 of the Act shall be $79,877.

The fee to accompany an application made under section 30 of the Act for the approval of a clinical trial, and of the persons (in that section called investigators) who will conduct that trial, shall be $9,843.

For the purposes of section 70(4) of the Act, the fee for a copy of a certificate of an analyst, or (as the case may be) a copy of a report made by an analyst in respect of a sample, shall be $60.

For the purposes of section 97(1) of the Act, the fee for procuring a sample of any medicine and submitting it for analysis shall be $600.

For the purposes of subclause (3), not generally available means not legally available other than pursuant to an exemption granted under any or all of sections 25, 26, 27, 28, 29, 30, 31, 32, 32A, or 33 of the Act.