This Act shall bind the Crown.

For the purposes of this Act, but subject to subsection (2), every person shall be deemed to manufacture, sell, supply, pack, or label any medicine whether he does so on his own account or as the agent or employee of any other person; and references to things done by a person in the course of a business shall be deemed to include references to things done by an agent or employee of that person in the course of that business.

For the purposes of this Act, if a person who is authorised by or under this Act to manufacture, sell, supply, pack, or label a medicine does so, in accordance with that authority, as the agent or employee of another person who is not so authorised, that other person shall not be held to have manufactured, sold, supplied, packed, or labelled that medicine.

For the purposes of this Act, while a person who is authorised by or under this Act to manufacture, sell, supply, pack, or label a medicine has that medicine in his custody or under his control as the agent or employee of another person who is not so authorised, that other person shall not be held to be in possession of that medicine.

For the purposes of this Act, any natural person who manufactures, sells, supplies, packs, or labels a medicine while working under the supervision and control of a responsible person or of another natural person authorised by or under this Act, otherwise than by section 32, to manufacture, sell, supply, pack, or label that medicine, shall be deemed to be the agent or employee of the responsible person or the person so authorised, and in any such case the responsible person or person so authorised shall be deemed to be the principal or employer of the first-mentioned person, without prejudice to the liability of any other person under section 79.

The Minister may from time to time appoint such advisory or technical committees as he thinks fit to advise him for any of the purposes of this Act, and may from time to time determine the functions of any such committee.

There may be paid out of money appropriated by Parliament for the purpose to the members of any committee appointed under this section remuneration by way of fees, salary, or allowances and travelling allowances and expenses in accordance with the Fees and Travelling Allowances Act 1951, and the provisions of that Act shall apply accordingly as if the committee were a statutory board within the meaning of that Act.

Subject to the provisions of this Act and of any regulations made under this Act, every such committee may determine its own procedure.

The Minister shall appoint under section 8 an advisory committee to be called the Medicines Classification Committee, whose duty it shall be to make recommendations to the Minister in respect of the classification of any medicines as prescription medicines or restricted medicines or pharmacy-only medicines under this Act.

The Committee shall also consider and report to the Minister on such other matters in relation to any of the purposes of this Act as may from time to time be referred to it by the Minister.

The Committee shall consist of—

The members of the Committee shall hold office—

Any member of the Committee may at any time be removed from office by the Minister for disability, neglect of duty, or misconduct proved to the satisfaction of the Minister, or may at any time resign his office by writing addressed to the Minister.

If any member of the Committee dies, resigns, or is removed from office, the vacancy so created shall be filled in the manner in which the appointment to the vacant office was originally made, and in the case of a vacancy in the office of a nominated member, every person so appointed shall be appointed for the residue of the term for which his predecessor was appointed.

Unless he sooner vacates his office under subsection (6), every nominated member of the Committee shall continue in office until his successor comes into office, notwithstanding that the term for which he was appointed may have expired.

The powers of the Committee shall not be affected by any vacancy in its membership.

At any meeting of the Committee, 4 members shall form a quorum.

Without limiting section 8, for the purposes of this Act there shall be a committee, to be called the Medicines Review Committee.

The Committee shall consist of 6 members appointed by the Minister, of whom 1 shall be appointed by the Minister as chairman, and shall include at least—

The Minister shall also appoint 1 person with wide experience in the practice of natural therapy to act as a member of the Committee whenever any matter relating to the practice of natural therapy is before the Committee.

There may be paid out of money appropriated by Parliament for the purpose to the members of the Committee remuneration by way of fees, salary, or allowances and travelling allowances and expenses in accordance with the Fees and Travelling Allowances Act 1951, and the provisions of that Act shall apply accordingly as if the Committee were a statutory board within the meaning of that Act.

In any case where the Minister is satisfied that any member of the Medicines Review Committee is incapacitated by illness or absence or other sufficient cause from performing the duties of his office, the Minister may appoint a deputy to act for that member during his incapacity.

No person shall be appointed a deputy under subsection (1) unless he is eligible for membership of the Committee under the same provision of section 10 as the member in whose place he is to act.

Every deputy appointed under this section shall, while he acts as such, be deemed to be a member of the Committee, and any deputy acting for the chairman shall have all the powers of the chairman.

No appointment of a deputy and no acts done by him as such, and no acts done by the Committee while any deputy is acting as such, shall be questioned in any proceedings on the ground that the occasion for his appointment had not arisen or had ceased.

The Medicines Review Committee may from time to time appoint such subcommittees comprising 2 or more members of the Committee as it thinks fit to hear and determine such matters as the Committee may from time to time delegate to them.

Notwithstanding subsection (1), where the Committee delegates to any subcommittee any matter relating to the practice of natural therapy, the person appointed under section 10(3) shall act as a member of the subcommittee.

Every subcommittee appointed under this section shall be subject in all things to the control of the Committee, and may at any time be discharged, altered, or reconstituted by the Committee.

Any delegation under this section may at any time be revoked by the Committee.

The functions of the Medicines Review Committee shall be as follows:

On receipt of an objection made in accordance with section 22(4), and of a deposit by the objector of the prescribed amount, the Committee shall inquire into the objection and report its findings to the Minister as soon as practicable.

On receipt of an appeal made in accordance with section 88, the Committee shall inquire into and determine the appeal as soon as practicable.

In carrying out its inquiries under subsection (2) or subsection (3), the Committee shall not be bound to follow any formal procedure, but shall observe the rules of natural justice, and shall consider all submissions made by or on behalf of the objector or appellant.

Every report by the Committee to the Minister on an objection shall include a recommendation as to the decision the Minister should make in respect of the matter to which the objection relates.

The Committee may make such order as to costs as it thinks fit.

Subject to any order made under subsection (6), the Committee shall, on completing its deliberations on any objection, refund to the objector the deposit paid by him under subsection (2).

Subject to the provisions of this section and of any regulations made under this Act, the Committee may determine its own procedure.

The Minister shall provide every committee appointed under section 8, and the Medicines Review Committee, with such staff, accommodation, services, and other facilities as appear to him to be necessary or expedient for the proper performance of its functions by that committee.

There may from time to time be appointed under the Public Service Act 2020 such officers as are required for the purposes of this Act.

The Director-General may from time to time appoint any person, not being an officer of the public service, as an officer, either in a part- or full-time capacity, for the purposes of this Act.

Any appointment under subsection (2) may be made either generally for the purposes of this Act or for any specified purpose, or for the exercise of any specified power or function of an officer under this Act, or for any specified period; and may be made in respect of New Zealand generally or in respect of any specified area or areas.

There may be paid out of money appropriated by Parliament for the purpose to any person appointed under subsection (2) such remuneration as may be fixed by the Director-General.

No person appointed under subsection (2) shall be deemed by reason of that appointment to be employed in the service of Her Majesty the Queen for the purposes of the Public Service Act 2020 or the Government Superannuation Fund Act 1956.

The Director-General, every Medical Officer of Health, and every other officer, shall exercise the powers and functions conferred on him by this Act subject to the direction and control of the Minister.

Subject to subsection (1), each Medical Officer of Health employed in the Ministry of Health, and every other officer of the Ministry of Health, shall exercise the powers and functions conferred on him by this Act subject to the direction and control of the Director-General of Health and of every other officer of the Ministry of Health to whom he is subordinate.

Where, by virtue of any provision of this Act, a reasonable belief in any particular state of affairs is a prerequisite for the exercise of any power by an officer, it shall be sufficient if the officer exercises that power at the direction of any other officer who is superior to him and who, at the time of giving the direction, held such a belief in that state of affairs.

Except as provided in sections 25 to 34, or as may be permitted by regulations made under this Act, no person shall, in the course of any business carried on by that person,—

otherwise than in accordance with a licence issued under Part 3.

Every person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding $40,000.

Except as provided in sections 25, 27, and 30 to 33, or as may be permitted by regulations made under this Act, no person shall, in the course of any business carried on by that person, sell by retail, or supply in circumstances corresponding to retail sale, or distribute by way of gift or loan or sample or in any other way,—

No person may sell by retail any prescription medicine otherwise than under a prescription given by an authorised prescriber, a veterinarian, or a delegated prescriber.

No person may supply, in circumstances corresponding to retail sale, any prescription medicine otherwise than—

Despite subsections (2) and (2A), a person may sell by retail, or supply, in circumstances corresponding to retail sale, any prescription medicine, where permitted by section 25 or section 30 or section 31 or section 69 or by regulations made under this Act.

Except as may be permitted by regulations made under this Act, no person shall hawk any prescription medicine or restricted medicine or pharmacy-only medicine—

otherwise than pursuant to any authority to do so expressly conferred by a licence held by him under Part 3, and in accordance with any conditions or restrictions specified in the licence.

Except as may be permitted by regulations made under this Act, no person shall sell any medicine by means of an automatic vending machine or by auctioning the medicine.

Every person who sells or supplies or distributes a prescription medicine in contravention of subsection (1) commits an offence and is liable to imprisonment for a term not exceeding 6 months or a fine not exceeding $40,000.

Every person commits an offence against this Act who contravenes any of the provisions of this section (otherwise than in circumstances that constitute an offence against subsection (5)).

A prescription medicine may be administered to any person only in accordance with—

Despite subsection (1), a prescription medicine may be administered where permitted by section 25 or by regulations made under this Act.

Every person commits an offence against this Act who contravenes subsection (1).

Except as provided in sections 25, 26(4), 28, 30, 31, and 32, this section applies to new medicines.

No person shall—

any medicine to which this section applies before the consent or provisional consent oft he Minister to the distribution of the medicine has been given by notice, or otherwise than in accordance with such conditions as may be imposed by the Minister on giving his or her consent or provisional consent and set out in the notice.

No consent given under this section shall be deemed to warrant the safety or efficacy of the medicine to which the consent relates.

A person who contravenes subsection (2) commits an offence, and is liable on conviction—

In any proceedings for an offence against subsection (4) in which it is alleged that this section applies to a medicine by reason of subsection (1), it shall be presumed that the medicine is a medicine to which this section applies until the contrary is proved.

The provisions of this section are in addition to, and not in substitution for, the provisions of any other enactment prohibiting, regulating, or restricting the sale or distribution of medicines, and nothing in any such other enactment shall authorise any person to act in contravention of the provisions of this section; but in the event of any conflict, the provisions of this section shall prevail.

The Minister, after having given consent or provisional consent to the distribution of any medicine in accordance with this Act, shall give written notification to the EPA of the consent or provisional consent and any condition attached to that consent.

Any consent that was given in respect of any medicine by the Minister under section 12(2) of the Food and Drug Act 1969 and in force immediately before the commencement of this Act shall be deemed for the purposes of this section and section 35 to have been given under this section.

A notice under subsection (2) is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

Every application for the Minister’s consent under section 20 shall—

The particulars required by subsection (1)(d) are the following:

Notwithstanding anything in subsection (1), in the case of a medicine to which section 20 applies by virtue of subsection (1) of that section, the notice deposited with the Director-General under section 24 shall, subject to subsections (4) and (5), be a sufficient application for the consent of the Minister under the said section 20.

At any time before the publication of a notice signifying the consent of the Minister to the distribution of a medicine in respect of which an application under section 20 has been made, the Director-General may, by notice in writing given to the person in whose name the application was made, require that person to supply—

as the Director-General may specify in his notice.

The Director-General may, if he thinks fit, require any person to verify by statutory declaration any statement in an application made, or in any further information or particulars supplied, under this section and signed by that person.

On receipt of an application for his consent to the distribution of a medicine for the purposes of section 20(2), the Minister shall—

If, after complying with subsection (1), the Minister is not satisfied that he should give his consent to the distribution of the medicine, he shall refer the matter to the appropriate committee, which shall consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make.

On receipt of the recommendation of the appropriate committee under subsection (2), the Minister shall, before making his decision, if the recommendation is to refuse consent to the distribution of the medicine, notify the applicant for consent of the terms of the recommendation, and of the reasons for it.

The applicant for consent may, within 28 days after being notified under subsection (3) of the recommendation of the appropriate committee, object to the recommendation in writing to the Minister.

On receipt of an objection under subsection (4), the Minister shall, before making his decision, refer the matter to the Medicines Review Committee, which shall convene such meeting or meetings as may be necessary for it to consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make.

Notwithstanding sections 20 to 22, the Minister may, by notice, in accordance with this section, give provisional consent to the sale or supply or use of a new medicine if the Minister is of the opinion that it is desirable that the medicine be sold, supplied, or used.

An application for the Minister’s provisional consent under this section shall—

On giving his provisional consent under this section, the Minister may impose—

as he thinks fit.

Subject to subsections (4A) and (5), every provisional consent given under this section shall have effect for 2 years or such shorter period as the Minister may determine, and shall then expire.

The Minister may, by notice, from time to time renew any provisional consent given under this section for a period not exceeding 2 years on any one occasion.

Subsections (3) and (5) shall apply to any renewal of a provisional consent given under subsection (4A) as if it were a provisional consent given under subsection (1).

If, during the currency of a provisional consent given in respect of any medicine, the Minister grants a consent under section 20 in respect of the same medicine, the provisional consent shall be deemed to be revoked.

A notice under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

In this section, and in sections 23B and 23C, unless the context otherwise requires,—

Where the Minister receives, or received not more than 5 years before the commencement date, an innovative medicine application and confidential supporting information, the Minister, during the protected period in relation to that confidential supporting information,—

Notwithstanding section 23B, the Minister may, during the protected period in relation to confidential supporting information,—

The power to grant consent under subsection (1)(a)(i) may be exercised by a person other than the applicant referred to in that subsection if—

If at any time a material change of a kind specified in subsection (2) is made by the manufacturer of a medicine, whether in New Zealand or elsewhere, and whether or not he was the manufacturer of the medicine before that change, the importer or manufacturer in New Zealand of the medicine shall, unless he is of the opinion that section 20 applies to the medicine by virtue of paragraph (a) or paragraph (b) or paragraph (c) of the definition of the term new medicine in section 3(3), deposit with the Director-General a notice in writing in English describing the change and giving particulars, so far as they are known, of any effect that the change might have on the safety and efficacy of the medicine.

Every notice deposited with the Director-General under subsection (1) shall be accompanied by the prescribed fee.

Subsection (1) applies to every material change in any of the following matters:

Except as provided in sections 25, 27, 28, 29, and 30, or with the prior written consent of the Director-General, no person shall—

until after the expiry of at least 90 days after the date on which such notice is deposited with the Director-General.

Within 45 days after the receipt of any notice in accordance with subsection (1), the Director-General may, by written notice to the importer or manufacturer, require the importer or manufacturer to supply such further information or particulars, or such samples, as the Director-General may require with respect to any matter set out in the importer’s or manufacturer’s notice.

If the Director-General, after considering the particulars, information, or samples required by or under subsection (1) or subsection (4), is of the opinion, at any time within the period specified in subsection (3),—

he shall refer the medicine to the Minister, and forthwith inform the importer or manufacturer by notice in writing that he has done so.

Every person commits an offence against this Act who—

A person who commits an offence under subsection (6) is liable on conviction—

The Director-General may grant an approval under section 38I of the Hazardous Substances and New Organisms Act 1996 for the release of a qualifying new medicine if he or she—

If the Director-General declines to grant an approval because the new organism is not a qualifying new medicine, then—

In sections 24D to 24G, unless the context otherwise requires,—

An application may be made to the Minister for approval to distribute, sell, or advertise in a special emergency a medicine that is or contains a hazardous substance or new organism.

The Minister may approve an application under subsection (1) with or without conditions, as long as the Minister is satisfied that—

An application under subsection (1) must—

The approval of an application under section 24D must be notified in the Gazette.

An approval of an application under section 24D takes effect on the day specified in the approval, and expires on the earlier of—

On the expiry of an approval of an application under section 24D, the medicine to which the approval applies must not be distributed or used unless authorised by or under any other provision of this Act.

An authorised prescriber may—

Despite subsection (1), in relation to any new medicine the distribution of which is prohibited under section 20,—

Subsection (1) applies despite sections 17 to 24, but is subject to the other provisions of this Act and any regulations made under this Act.

Notwithstanding section 17, but subject to subsections (2) and (3) and to the other provisions of this Act and to any regulations made under this Act, a pharmacist may manufacture, pack, label, sell, and supply any medicine.

The authority conferred by subsection (1) shall extend only to the manufacture, packing, labelling, selling, or supplying of medicines,—

Subsection (1) shall not authorise—

Subject to subsection (2), nothing in section 20 or section 24 shall apply in respect of the sale or supply by a pharmacist of a medicine compounded by that pharmacist to suit the needs of a particular person.

Notwithstanding anything in section 17 or section 18, but subject to the other provisions of this Act and to any regulations made under this Act,—

Notwithstanding section 17, but subject to the other provisions of this Act and to any regulations made under this Act, any person may, in the course of a business carried on by that person, manufacture, pack, and label, or sell or supply, any herbal remedy for administration to a particular person after being requested by or on behalf of that person to use his own judgment as to the treatment required.

Notwithstanding anything in sections 17 and 20 to 24, but subject to the other provisions of this Act and to any regulations made under this Act, any person may manufacture, pack, and label any herbal remedy, and sell or supply any herbal remedy, if the remedy is or is to be sold or supplied—

Neither section 20 nor section 24 shall prevent—

Every person who, for the purposes of subsection (1), sells or supplies to any practitioner any medicine that is a new medicine by virtue of paragraph (a) of the definition of the term new medicine in section 3(3) before the consent of the Minister to the distribution of that medicine has been published under the Legislation Act 2019 shall, as soon as practicable after the end of every month in which he has so sold or supplied any such medicine, report that sale or supply to the Director-General in writing, naming the practitioner and patient, describing the medicine, and identifying the occasion when and the place where the medicine was so sold or supplied.

Without limiting section 48, if any person fails to comply with subsection (2), the Minister may, in the manner prescribed in that section but without complying with subsection (2) of that section, prohibit that person from selling and supplying any new medicine to which subsection (2) applies before the consent of the Minister to the distribution of that medicine has been published under the Legislation Act 2019.

Notwithstanding section 20 or section 24, but subject to the succeeding provisions of this section, the importer or manufacturer in New Zealand of any medicine may distribute it for the sole purpose of obtaining clinical and scientific information with respect to its safety and efficacy, if the clinical trial, and the persons (in this section called the investigators) who will conduct the trial, have been approved by the Director-General on the recommendation of the Health Research Council of New Zealand.

An application for the approval of the Director-General in respect of this section shall be made by the importer, manufacturer, or packer, or the intending manufacturer, packer, seller, or supplier, in New Zealand of the medicine, and shall—

The particulars required by subsection (2)(d) are the following:

The Director-General shall determine every application for his approval under this section within 45 days after the receipt of the application, and shall notify the applicant of his decision and (where he declines the application) the reasons for his decision.

At any time after a clinical trial has been approved by the Director-General, the applicant may apply to the Director-General for the approval of an investigator, notwithstanding that the name of that person did not appear in the application for approval of the clinical trial; and paragraphs (a) to (c) of subsection (2), and paragraphs (c), (d), and (g) of subsection (3), shall apply in respect of every such application.

The Director-General may at any time, by notice in writing given to an applicant, require the applicant to supply such further information and particulars as he thinks fit relating to a clinical trial or to the identity and qualifications of an investigator.

The distribution of any medicine under this section shall be subject to the following conditions:

The Director-General may at any time, by notice in writing to the applicant, revoke or suspend his approval of a clinical trial.

Notwithstanding sections 17 to 24, but subject to subsections (2) and (3) and to the other provisions of this Act and to any regulations made under this Act,—

shall extend and apply to any agent or employee of a person so authorised acting in the course of that person’s agency or employment.

Except as provided in regulations made under this Act, any authority conferred by subsection (1) to sell, supply, pack, or label a medicine shall,—

Subsection (1) shall not authorise a person to manufacture, sell, supply, pack, or label a medicine—

Subsection (3)(a) does not apply in respect of any authority conferred by section 26 on a pharmacist or on a pharmacist employed or engaged by a person who is not a pharmacist but who holds a licence to operate a pharmacy.

Notwithstanding sections 17 and 20 to 24 or anything in any licence, but subject to the other provisions of this Act and to any regulations made under this Act, any natural therapist or other person may manufacture, pack, label, sell by retail, or supply in circumstances corresponding to retail sale, any medicine that neither is nor contains—

for administration to a particular person after being requested by or on behalf of that person to use his own judgment as to the treatment required.

Notwithstanding anything in this Act, but subject to subsection (2), the Crown may, in respect of any medicine approved by the Director-General for the purposes of this section,—

and, subject to subsection (2), in doing any of those things, it shall not be necessary for the Crown to comply with any of the provisions of this Act.

Nothing in subsection (1) limits or affects the application to the Crown of sections 20, 44, and 45.

Section 50(2), to the extent that it relates to the payment of a fee on the application for a licence to sell a medicine by wholesale, applies to the Crown in the same way as it applies to other persons in any case where the Crown would, but for subsection (1), be required to obtain a licence to sell a medicine imported by the Crown under subsection (1) by wholesale.

Nothing in section 24 prevents a person who holds a licence to sell a medicine imported by the Crown under subsection (1) by wholesale from selling the medicine, or supplying it by way of gift or loan or sample or in any other way.

Nothing in section 24 prevents—

The powers conferred by this section to do anything in respect of a medicine include the power to do likewise in respect of any advertising material, container, label, labelling material, or package (as those terms are defined in section 2), or a data sheet or other written or printed material, relating to that medicine.

In this section the term sell includes the matters specified in paragraphs (a) to (c) of the definition of that term in section 2.

Notwithstanding sections 17 to 24 or anything in any licence, but subject to the other provisions of this Act and to any regulations made under this Act,—

Section 17 does not apply in respect of the sale by wholesale of a medicine that is not a prescription medicine or a restricted medicine or a pharmacy-only medicine.

This section applies if—

The Director-General may, by notice, authorise the administration of the vaccine other than in accordance with the data sheet.

The notice may specify any 1 or more of the following matters in relation to the administration of the vaccine:

Before issuing a notice under this section, the Director-General must—

A COVID-19 vaccine is not a new medicine for the purpose of section 20 by reason only of—

Any person or class of persons permitted by the Act or by regulations to administer the vaccine may administer the vaccine in accordance with the notice.

Nothing in this section limits section 24.

A notice made under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

The Minister may at any time, by notice, revoke, or suspend for such period as he may determine, any consent given under section 20 or section 23, if he is of the opinion that—

Where a consent is suspended under this section, it shall be deemed for the purposes of subsections (2) and (4) of section 20 not to have been granted.

A notice under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

Without limiting subsection (5) of section 24, if the Director-General has reason to believe that any medicine, not being a new medicine, may be unsafe or ineffective for the therapeutic purpose for which it is sold, he may, by notice in writing to an importer or manufacturer in New Zealand, state the reasons for his belief and require the importer or manufacturer to satisfy him of the safety or efficacy of that medicine.

If the Director-General is not satisfied, by evidence supplied to him pursuant to a notice under subsection (1) or otherwise, of the safety and efficacy of a medicine to which that notice relates, he may at any time after the expiration of 60 days from the date of that notice refer a description of the medicine to the appropriate committee, and shall forthwith by notice in writing inform the importer or manufacturer that he has done so.

In any case to which this section applies, the Minister may, by notice in writing to the importer or manufacturer,—

The Minister may at any time, by a like notice, revoke any notice given under subsection (3), or vary, revoke, or add to any conditions imposed in any such notice.

Every person commits an offence and is liable on conviction to imprisonment for a term not exceeding 6 months or a fine not exceeding $5,000 who sells or supplies any medicine in contravention of a notice given under subsection (3), or of a condition imposed in any such notice or in a notice given under subsection (4).

The Minister may from time to time, by notice, prohibit the import, manufacture, packing, sale, possession, supply, administration, or other use of medicines of any specified description or medical devices of any specified kind, either absolutely or subject to such conditions as he thinks fit, for any specified period not exceeding 1 year; but he shall not exercise this power more than once in respect of medicines or medical devices so specified.

Where the Minister gives a notice under subsection (1), he shall, on the written request of any person, state his reasons for doing so.

Every person commits an offence against this Act who contravenes any notice given under subsection (1).

A notice under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

For the purposes of this section,—

If the Director-General has reason to believe that any medical device may be unsafe, he may, by notice in writing to the importer or manufacturer in New Zealand, state the reasons for his belief, and require the importer or manufacturer to satisfy him of the safety of that medical device.

The importer or manufacturer shall supply to the Director-General, within 45 days after receiving the notice under subsection (2), or such further time as the Director-General may allow, evidence of the safety of the medical device.

If the Director-General is not satisfied, by evidence supplied to him pursuant to a notice under subsection (3) or otherwise of the safety of the medical device, he may at any time, within the period of 45 days following the receipt of that evidence, by a further notice under subsection (2) require the manufacturer or importer to supply him with further evidence of the safety of the medical device.

The fact that the Director-General does not exercise the powers conferred on him by this section in respect of a medical device shall not be deemed to warrant the safety of the medical device.

The Director-General may exercise the powers conferred on him by this section from time to time with respect to different importers or manufacturers of the same kind of medical devices, and the fact that he has not exercised any of those powers in respect of a particular kind of medical device, or that he has informed any person that he is satisfied of the safety of a particular kind of medical device, shall not prevent him from exercising any such power in respect of that kind of medical device where new information comes to his attention.

In any proceedings for an offence against this section in which it is alleged that 2 or more medical devices are of the same kind, it shall be presumed that those medical devices are of the same kind until the contrary is proved.

Every person commits an offence and is liable on conviction to imprisonment for a term not exceeding 6 months or a fine not exceeding $5,000 who,—

No person shall—

Every person commits an offence against this Act who contravenes subsection (1).

If a standard is prescribed in respect of a medicine, or a medical device, or the ingredient of a medicine, no person shall, in the course of any business, sell or supply any substance or article under a name that is likely to cause the person to whom the substance or article is sold or supplied to believe that that person is purchasing or otherwise acquiring that medicine, or that medical device, or a substance containing that ingredient, unless the substance or article, or the ingredient of the substance or article, complies with the standard.

If a person sells an article to a purchaser in response to a request for a medicine or a medical device of a kind for which a standard is prescribed, he shall be deemed to sell a medicine or medical device of that kind and under such a description as is specified in subsection (1) unless he clearly notifies the purchaser at the time of sale that the article is not of that kind.

Notwithstanding that a medicine, or a medical device, or an ingredient of a medicine, otherwise conforms with the standard prescribed for that medicine, medical device, or ingredient, it shall be deemed not to conform with that standard if anything has been added to it—

Every person commits an offence against this Act who contravenes subsection (1).

If at any time the importer or manufacturer in New Zealand of any medicine has reason to believe that any substantial untoward effects have arisen from the use of the medicine whether in New Zealand or elsewhere, the importer or manufacturer shall forthwith notify the Director-General of the nature of those effects and the circumstances in which they have arisen, so far as they are known to him.

Every person commits an offence against this Act and is liable on conviction to a fine not exceeding $1,000 who fails to comply with subsection (1).

No importer or manufacturer shall sell, or distribute by way of gift or loan or sample or in any other way, or advertise for sale, or advertise the availability of, any medicine other than a herbal remedy unless he is in possession of—

Every importer or manufacturer in New Zealand shall, on demand, supply to an officer the details and certificates referred to in subsection (1).

A person who contravenes this section commits an offence, and is liable on conviction—

No person may operate any pharmacy that is not for the time being under the immediate supervision and control of a pharmacist.

Every person who operates a pharmacy must ensure that every prescription medicine or restricted medicine in the pharmacy is at all times secured in a way that prevents the public gaining ready access to the medicine.

Every person who operates a pharmacy must ensure that all medicines held in storage for the purposes of the pharmacy are secured in a way that prevents the public gaining access to the medicines.

Subsections (1) and (2) do not prevent a pharmacist engaged at the pharmacy or another person authorised by a pharmacist engaged at the pharmacy, from supplying any medicine to a member of the public.

The requirements imposed by subsections (1) and (2) are in addition to the requirements imposed by section 47 or any regulations made under this Act.

No authorised prescriber or delegated prescriber may hold an interest in a pharmacy other than a pharmacy for which the person holds a licence to operate, except with the consent of the licensing authority and in accordance with any conditions or restrictions imposed by that authority.

No person who has an interest in a pharmacy may permit or enable any authorised prescriber or delegated prescriber to hold or acquire that or any other interest in the pharmacy contrary to subsection (1).

The licensing authority may not give its consent under subsection (1) unless it is satisfied that there are sufficient safeguards to prevent the issue of prescriptions, the manner in which prescriptions are issued, or the other provision of health care by the authorised prescriber or delegated prescriber from being influenced by the commercial or financial interests of the authorised prescriber, or delegated prescriber, or any other person holding an interest in the pharmacy.

No person shall, without reasonable excuse, import, procure, receive, store, use, or otherwise have in his possession, any prescription medicine.

Without limiting the meaning of the expression reasonable excuse in subsection (1), a person has a reasonable excuse for the purpose of that subsection if—

In any proceedings under this section against any person in which it is proved that that person procured, received, stored, used, or otherwise had in his possession any prescription medicine, the onus of proving that he had a reasonable excuse (whether by reason of the fact that 1 or more of the provisions of paragraphs (a) to (e) of subsection (2) apply to his case or otherwise) shall lie on the defendant.

In any proceedings under this section, the fact that the defendant did not know that the medicine that is the subject of the prosecution was a prescription medicine is not by itself a reasonable excuse.

Every person commits an offence against this Act who contravenes subsection (1).

Except as may be permitted by regulations made under this Act, no person shall, in the course of any business, pack, store, sell, supply, or cause to be transported any medicine, unless—

Notwithstanding subsection (1)(a)(ii), where—

the container need not be of a type that can be readily and effectively resealed.

Every person commits an offence against this Act who contravenes subsection (1).

Every person who, in the course of any business, manufactures, packs, or sells, or supplies in circumstances corresponding to retail sale, any medicine shall keep, in some place of security at his place of business, such records as may be prescribed and shall retain them for such period as may be prescribed.

Every person who, in the course of any business, manufactures, packs, or sells, or supplies in circumstances corresponding to retail sale, any medicine shall at all times permit any officer, or any constable, to inspect and make copies of any such record, and shall at all times on demand afford to any officer or to any constable all further information in his possession with respect to any dealings by that person relating to medicines.

Every person commits an offence against this Act who—

Every person commits an offence against this Act who has any medicine in his charge or possession (whether for the purposes of sale or for any other purpose) otherwise than in a container conforming to the relevant requirements (if any) of this Act and of any regulations made under this Act, except in the course of manufacturing or packing that medicine.

It is a defence to a charge brought under subsection (1) if the defendant proves that, at the material time,—

No person who is in possession or charge of any prescription medicine or restricted medicine shall put it—

No person shall pack any medicine, or prepare it for use, in any room, or on any table or bench, that is used for the purpose of packing, preparing, or consuming any food or drink.

Except as otherwise provided in any regulations made under this Act, no person who is in possession, for the purposes of any business, of a prescription medicine or a restricted medicine that is kept for the time being within any building or vehicle shall leave that building or vehicle unattended, unless he has taken all reasonable steps to secure that building or vehicle, or the part of it in which the medicine is kept, against unlawful entry.

No person shall deliver on retail sale, or in circumstances corresponding to retail sale, any medicine otherwise than through the post or by handing it or causing it to be handed to the person, or another person reasonably believed to be acting on that person’s behalf, to whom it is addressed or for whose use it is intended.

Every person commits an offence against this Act who, without reasonable excuse, contravenes any of the provisions of this section.

If regulations made under sections 105(1)(qaa) and 105D grant delegated prescribing rights to a class of registered health professional,—

The Minister may at any time, by notice in the Gazette,—

The Minister may not exercise any power conferred on him or her by subsection (1),—

The Minister may at any time, by notice in the Gazette, revoke any notice given under subsection (1).

Despite anything in any other Act, each council or board referred to in section 48 has jurisdiction to inquire into any prescribing of or dealing in medicines by a member of the profession with which it is concerned, and any other incidental matter, for the purpose of considering and determining whether or not to make a recommendation to the Minister under that section, when such prescribing or dealing has been brought or otherwise comes to its attention.

For the purposes of subsection (1), each such council or board has and may exercise any powers with respect to summoning witnesses, administering oaths, hearing evidence and other matters of procedure, and with respect to the payment and receiving of costs and expenses, conferred on it or any disciplinary committee or disciplinary tribunal, in relation to disciplinary proceedings, by the enactment under which the council or board is constituted.

Despite subsection (2), it is not necessary, unless the council or board so requires, for any other body to conduct an investigation or inquiry or to be represented at the inquiry conducted by the council or board.

Without prejudice to the liability of any person under any other provision of this Act, a person who contravenes any notice given under section 48(1) commits an offence against this Act.

In this section the term restricted person means a person who is the subject of a notice given under subsection (2) and for the time being in force.

Where a Medical Officer of Health is satisfied that any person—

he may from time to time, by notice in such form as he thinks fit, prohibit, subject to such conditions and exceptions as he may prescribe in the notice, any authorised prescriber or delegated prescriber from issuing prescriptions for the supply of, and any person from supplying, that or any similar prescription medicine or that or any similar restricted medicine, to the restricted person.

The Medical Officer of Health may at any time, by a like notice, revoke, or vary, or modify any prohibition, condition, or exception contained in a notice given by him under this section.

The Medical Officer of Health shall cause a copy of every notice under subsection (2) or subsection (3) to be served on the restricted person, but a failure to comply with this requirement shall not invalidate the notice.

Any person who is aggrieved by the issue of a notice under this section, or by the refusal of the Medical Officer of Health to revoke, vary, or modify any prohibition, condition, or exception contained in any such notice, may appeal in writing to the Minister whose decision shall be final.

Every person commits an offence against this Act who—

If a Medical Officer of Health has reason to believe that any person is or is likely to become dependent on any prescription medicine or restricted medicine, the Medical Officer of Health may, for the purpose of preventing or restricting the supply of prescription medicines or restricted medicines to that person, or of assisting in the cure or mitigation or avoidance of the dependence of that person, publish statements relating to that person to all or any of the members of all or any of the classes of persons set out in subsection (3).

Every statement made under subsection (1) shall be privileged unless the publication is proved to be made with malice.

The classes of persons referred to in subsection (1) are as follows:

Nothing in subsection (1) or subsection (2) shall limit or affect any right or duty that a Medical Officer of Health may otherwise possess to publish a statement to any person.

Every person commits an offence against this Act who, except in the course of duty as a member of a class set out in subsection (3) or as an officer or servant of the Crown, publishes any information obtained, whether by that person or any other person, from a statement made pursuant to subsection (1), or any comment on any such statement.

Every application for a licence must be made in the prescribed form to the Director-General or to any person designated for the purpose by the Director-General by notice in the Gazette.

Every such application shall contain or be accompanied by such particulars, information, documents, samples, and other material as may be prescribed, and shall be accompanied by the prescribed fee.

The application shall indicate the descriptions of the medicines in respect of which the licence is sought, either by specifying those descriptions, or by reference to an appropriate general classification.

An application may be made either by an individual who is a New Zealand resident on the person’s own behalf or by an appropriate officer of a body corporate that is incorporated in New Zealand on behalf of that body corporate.

If a person authorised to receive an application under subsection (1) is satisfied that an application complies with the requirements of this section and of any regulations made under this Act that are applicable to the application, the person must refer the application to the licensing authority.

Subject to subsection (2) and to sections 52, 55A, and 55B, on receiving an application, the licensing authority shall issue a licence, in accordance with regulations made under this Act, to the applicant if he is satisfied in respect of all the following matters:

In determining, under subsection (1)(b), whether an applicant is a fit and proper person or of good repute (as the case requires), the licensing authority may take into account, among other things,—

Except as may be permitted by regulations made under this Act, the licensing authority shall not issue a licence to sell medicines by retail in respect of any premises other than a shop that is open to the public and is situated at least 10 kilometres by the most practicable route from a pharmacy in respect of which a licence to operate has been, or is deemed to have been, issued.

The licensing authority shall not decline an application for a licence under this section without first giving the applicant a reasonable opportunity to be heard.

A licence—

The licensing authority may, by written notice to the holder of a licence, revoke or amend any condition imposed under subsection (4)(b)(i) or add any new condition.

A licence to sell a medicine may be combined with a licence to pack that medicine.

If in any case the licensing authority is satisfied that the holder of a licence has failed or is failing to comply with any conditions attached to the licence, the licensing authority may cancel the licence.

The licensing authority may not cancel a licence under subsection (6) unless the holder has been given a reasonable opportunity to be heard, or to make written submissions, in relation to the matter.

The licensing authority may suspend a licence for a reasonable period to enable the licensing authority to consider whether to cancel the licence under subsection (6).

If the licensing authority is satisfied that the holder of a licence to operate a pharmacy has failed to comply with any conditions affecting the licence, the licensing authority may, instead of or as well as exercising the powers conferred by subsection (4A) or (6),—

A penalty imposed under subsection (6A) may be recovered in a court of competent jurisdiction as a debt due to the licensing authority.

If the licensing authority refuses to issue a licence, or attaches conditions to a licence, or cancels a licence under this section or under section 55A, and the applicant for the licence or the licensee requests him to give his reasons for such refusal, or for the attachment of such conditions, or for the cancellation of the licence, the licensing authority shall state his reasons in writing to that person accordingly.

In this section, professional conduct committee means a committee appointed under section 71 of the Health Practitioners Competence Assurance Act 2003.