DRAFT FOR CONSULTATION

Therapeutic Products Bill

Government Bill

Hon Dr David Clark

Therapeutic Products Bill

Government Bill

Contents

1 Title
2 Commencement
3 Purpose
4 Principles guiding exercise of powers under this Act
5 Transitional, savings, and related provisions
6 Act binds the Crown
7 Outline of regulatory scheme
8 What is covered by regulatory scheme
9 Product approvals
10 Controlled activities
11 Authorisations: subpart 3 of Part 3, licences, and permits
12 Obligations of other people
13 Administration of regulatory scheme
14 Interpretation
15 Meaning of therapeutic purpose
16 Meaning of therapeutic product
17 Types of therapeutic products
18 Meaning of medicine
19 Categories of medicine
20 Meaning of AMI (active medicinal ingredient)
21 Meaning of medical device
22 Supply-restricted devices and use-restricted devices
23 Meaning of type-4 product
24 Meanings of approved product, approval-exempt product, and unapproved product
25 Meaning of prohibited product
26 Meanings of administer and prepare for administration
27 Meaning of clinical trial
28 Meaning of compound
29 Meaning of dispense
30 Meaning of import
31 Meanings of manufacture, manufacturer, and responsible manufacturer
32 Meaning of manufacture, for medicine
33 Meaning of manufacture, for AMI
34 Meaning of manufacture, for medical device
35 Meaning of manufacture, for type-4 product
36 Meanings of pharmacy business and pharmacy activity
37 Meanings of pharmacy worker and qualified
38 Meanings of prescription, complying prescription, and prescribe
39 Meanings of special clinical needs supply authority and complying special clinical needs supply authority
40 Meanings of standing order and complying standing order
41 Effect of complying standing order
42 Meaning of supply
43 Meanings of wholesale supply and non-wholesale supply
44 Meanings of supply chain activity and person in the supply chain
45 Meaning of take overseas
46 Meanings of use and prepare for use
47 Fit and proper person
48 Meaning of senior manager
49 Meanings of work and worker
50 Examples
51 Product approval required to import or supply medicine, medical device, or type-4 product
52 Sponsor’s consent required to import approved product
53 Authorisation required for controlled activity
54 Non-wholesale supply of category 1 medicine: prescription required
55 Persons in supply chain must comply with regulations
56 Effect of this subpart
57 Pharmacists: approved and approval-exempt medicines
58 Pharmacists: unapproved products
59 Pharmacists: wholesale supply (approved, approval-exempt, and unapproved products)
60 Qualified pharmacy workers
61 Health practitioners: approved and approval-exempt medicines
62 Health practitioners: unapproved products
63 Health practitioners: wholesale supply (approved, approval-exempt, and unapproved products)
64 Health practitioners: special clinical needs supply authority
65 Health practitioner’s staff: non-wholesale supply of category 3 medicine
66 Veterinarians: approved medicines
67 Veterinarians: unapproved products
68 Veterinarians: wholesale supply (approved, approval-exempt, and unapproved products)
69 Veterinarians: special clinical needs supply authority
70 Veterinary staff
71 Person authorised by standing order
72 Downstream supply or administration of medicine to patient
73 Possession of category 1 medicine
74 Possession of category 1 AMI
75 Manufacture of custom-made devices
76 Patient or carer importing medicine for personal use
77 Patient or carer importing medical device for personal use
78 Authorisation for unapproved product stock in supply chain
79 Regulations may grant authorisations
80 Vending machines for medicine to be expressly authorised
81 Prohibited products
82 Meaning of advertisement and related terms
83 Advertising
84 Meaning of tamper with and create a risk of harm
85 Tampering with therapeutic products
86 Supply of tampered-with therapeutic products
87 Notifying Regulator of suspicion of tampering
88 Misrepresentation about therapeutic product
89 Holding out
90 Agreeing or offering to carry on supply chain activity unlawfully
91 Obtaining therapeutic product when supply is unlawful
92 Misleading information in records
93 Health practitioner prescriber must not hold interest in pharmacy business
94 Approval of medicines, medical devices, and type-4 products
95 Criteria for product approval
96 Product standards
97 Criteria for sponsor of approved product
98 Content of approval
99 Scope of approval
100 Major changes results in new product
101 Sponsor must notify Regulator of certain minor changes
102 Change of sponsor
103 Duration of approval
104 Approval lapses on death, bankruptcy, or insolvency of sponsor
105 Conditions on approval
106 Regulator may impose conditions
107 Variation of conditions of approval
108 Grounds to cancel approval
109 Regulator may cancel approval if grounds exist
110 Procedure to cancel approval
111 Regulator may cancel approval on application
112 Effect of cancellation
113 Therapeutic products register
114 Approval-exempt products
115 Sponsor of approval-exempt product
116 Sponsor of approved product must ensure compliance with approval
117 Sponsor must ensure compliance with product standards
118 Sponsor must comply with regulations
119 Sponsor not responsible for approved products imported without consent
120 Interpretation for this subpart
121 Periods when protected active ingredient information may not normally be disclosed or used
122 Limited circumstances in which protected active ingredient information may be disclosed or used
123 What licence may authorise
124 Content of licence
125 Effect of licence
126 Effect of pharmacy licence: additional provisions
127 Grant of licence
128 Criteria for granting licence
129 Criteria for licensee
130 Criteria for responsible persons
131 What permit may authorise
132 Content of permit
133 Effect of permit
134 Grant of permit
135 Criteria for granting permit
136 Regulator may split application
137 Duration
138 Conditions
139 Regulator may impose conditions
140 Variation
141 Grounds to suspend or cancel licence
142 Grounds to suspend or cancel permit
143 Regulator may suspend or cancel if grounds exist
144 Procedure to suspend or cancel
145 Regulator may suspend or cancel on application
146 Duration of suspension
147 Lifting of suspension
148 Effect of suspension
149 Effect of cancellation
150 Licence or permit not transferable
151 Death, bankruptcy, or insolvency of licensee or permit holder
152 Register of licences and permits
153 Licensee must ensure responsible person has authority and resources
154 Licensee must ensure health practitioner has authority and resources
155 Licensee or manager must not induce health practitioner to act unprofessionally
156 Responsible person must report non-compliance
157 Protection of responsible person from retaliation
158 Responsible person must comply with regulations
159 Licensee must ensure only authorised persons carry on pharmacy activities
160 Regulator to monitor safety
161 Public safety announcements
162 Recall order
163 Compliance with recall order
164 Premises restriction order
165 Compliance with premises restriction order
166 Advertising remediation order
167 Compliance with advertising remediation order
168 Directions order
169 Compliance with directions order
170 Product prohibition order
171 Compliance with product prohibition order
172 Regulator’s powers in relation to oversupplied persons
173 Medicine access limitation order
174 Compliance with medicine access limitation order
175 Statement about oversupplied person
176 Information in statement to be kept confidential
177 Content of regulatory orders
178 Making regulatory order
179 Regulatory orders in relation to something misrepresented to be therapeutic product
180 Regulatory order overrides other provisions of Act
181 Variation of regulatory orders
182 Revocation of regulatory order
183 Interpretation for investigative powers
184 How powers are exercised
185 Regulator may require information
186 Testing of samples for investigative purposes
187 Laboratories and analysts
188 Imported consignments may be detained pending testing
189 Entry and inspection without warrant
190 Homes and other special places
191 Entry and inspection with warrant
192 Power to require things to be held unaltered
193 Destruction of seized things
194 Removal from New Zealand of seized things that were imported
195 Cost recovery
196 Customs information
197 Misleading information to Regulator
198 Compliance with investigative requirements
199 Obstructing Regulator
200 Application for review of Regulator’s decision
201 Regulator to convene review panel
202 Procedure on review
203 Decision on review
204 Appeal to District Court
205 Functions and powers generally
206 Meaning of opportunity to comment
207 Regulator may rely on recognised authorities
208 Notice and reasons for decision by Regulator
209 Sharing of information with regulatory agencies, etc
210 Power of Regulator to act on requests of overseas regulators, etc
211 Applications to Regulator
212 Regulator may request further information, site access, etc
213 Regulator may obtain information
214 Information is part of application
215 Regulator may reject non-complying application
216 Opportunity to comment before adverse decision
217 Notice of decision
218 Notification to Regulator
219 Meaning of make publicly available
220 Service of documents
221 Certificate of status for overseas supply of therapeutic product
222 Correction of errors
223 Regulator may accept undertakings
224 Undertakings to be made publicly available
225 When undertaking is in force
226 Withdrawal of enforceable undertaking
227 Variation of enforceable undertaking
228 Compliance with enforceable undertaking
229 Contravention of enforceable undertaking
230 Proceedings for alleged contravention
231 Limitation period for proceedings after undertaking contravened or withdrawn
232 Court may grant injunction
233 Penalties for offences
234 When court may make other orders
235 Suspension or cancellation of licence or permit
236 Cancellation of approval
237 Order to pay Regulator’s expenses of mitigating risk harm
238 Notice of court orders
239 Conduct of senior managers, workers, and agents attributed upwards
240 Authorisation for attributed conduct
241 State of mind of senior managers, workers, or agents attributed upwards
242 Contravention of body corporate attributed downward to senior managers
243 All reasonable steps
244 Reasonable excuse
245 Reliance on information from another person
246 Compliance with specified standard
247 Presumption that contents are as labelled
248 Evidence of testing
249 Meaning of infringement circumstances and infringement offence
250 Meaning of infringement fee and infringement fine
251 Penalty for infringement offence
252 How infringement offences may be dealt with
253 Regulator may issue infringement notice
254 Form and content of infringement notice and reminder notice
255 Infringement notice may be revoked
256 Costs to be recovered
257 Regulations about fees and charges
258 Types of secondary legislation and instruments
259 Interaction between types of secondary legislation and instruments
260 Application of Legislation Act 2012
261 Regulations
262 Rules
263 Regulator’s notices
264 Exemptions
265 Scope of regulations, rules, Regulator’s notices, and exemptions
266 Incorporation by reference
267 Consultation
268 Minister must review Act
269 Relationship with Food Act 2014
270 Relationship with Hazardous Substances and New Organisms Act 1996
271 Relationship with Human Tissue Act 2008
272 Relationship with Misuse of Drugs Act 1975
273 Relationship with Psychoactive Substances Act 2013
274 Relationship with Radiation Safety Act 2016
275 Repeals and revocations
276 Amendments to Health Practitioners Competence Assurance Act 2003
277 Section 5 amended (Interpretation)
278 Section 11 amended (Authorities must specify scopes of practice)
279 New section 11A inserted (Scope of practice may include prescribing of medicinal products and issuing of standing orders)
11A Scope of practice may include prescribing of medicinal products and issuing of standing orders
280 Section 14 amended (Provisions relating to notices under sections 11 and 12)
281 New sections 14A and 14B inserted
14A Amendment of scope of practice that includes prescribing of medicinal products
14B Minister’s powers under sections 11A and 14A
282 Section 67 amended (Notification of convictions)
283 Section 100 amended (Grounds on which health practitioner may be disciplined)
284 Section 170 amended (Regulations)
285 Schedule 1AA amended (Transitional, savings, and related provisions)
286 Amendment to Search and Surveillance Act 2012
287 Schedule amended
288 Amendment to Customs and Excise Act 2018
289 Section 242 amended (Power to seize and detain risk goods or goods involved in certain offences, etc)
290 Amendments to other enactments

The Parliament of New Zealand enacts as follows:

1 Title

This Act is the Therapeutic Products Act 2018.

2 Commencement

(1)

This Act comes into force on a date appointed by the Governor-General by Order in Council.

(2)

One or more Orders in Council may be made appointing different dates for different provisions.

(3)

To the extent that it is not previously brought into force under subsection (1), this Act comes into force on [xx xx ].

[Note for consultation draft: The date will be inserted in subsection (3) prior to the Bill being introduced. It is proposed that it will be approximately 2 years after the Bill receives the Royal assent.]

Part 1 Preliminary provisions

3 Purpose

The purpose of this Act is to protect personal and community health by—

(a)

ensuring acceptable safety, quality, and efficacy or performance of therapeutic products across their lifecycle; and

(b)

regulating the manufacture, import, promotion, supply, and administration or use of therapeutic products.

4 Principles guiding exercise of powers under this Act

The Regulator and any other person exercising a power under this Act must be guided by the purpose of this Act and the following principles:

(a)

the likely benefits of therapeutic products should outweigh the likely risks associated with them:

(b)

regulation of therapeutic products should—

(i)

be proportionate to the risks posed by the products; and

(ii)

support the timely availability of therapeutic products:

(c)

the administration of this Act should be carried on in an open and transparent manner:

(d)

there should be co-operation with overseas regulators, compliance with international obligations, and, if appropriate, alignment with international standards and practice.

5 Transitional, savings, and related provisions

The transitional, savings, and related provisions set out in Schedule 1 have effect according to their terms.

6 Act binds the Crown

This Act binds the Crown.

Outline of regulatory scheme

7 Outline of regulatory scheme

(1)

This Act regulates therapeutic products in New Zealand.

(2)

Sections 7 to 13 give a broad summary of the regulatory scheme. However, they are a guide only and do not affect the meaning of this Act.

(3)

The scheme consists of 2 broad components—

(a)

product approval requirements; and

(b)

controlled activity restrictions.

(4)

The product approval requirements regulate which products may be imported into, or supplied in, New Zealand.

(5)

The controlled activity restrictions regulate how therapeutic products (whether approved or not) can be dealt with. The controlled activities include manufacturing and supplying therapeutic products, prescribing and administering medicines, and using medical devices and other therapeutic products on patients.

8 What is covered by regulatory scheme

(1)

Therapeutic products are any products that are intended for use in, on, or in relation to humans for a therapeutic purpose, or for use as an active ingredient of a medicine (see sections 15 and 16).

(2)

They are divided into 4 types—medicines, active medicinal ingredients (known as AMIs), medical devices, and type-4 products (see sections 18, 20, 21, and 23).

9 Product approvals

(1)

Therapeutic products (other than AMIs) are regulated by means of product approvals.

(2)

Generally, a therapeutic product (other than an AMI) cannot be imported into New Zealand or supplied in New Zealand unless the product is approved (see section 51).

(3)

The process for getting a product approved is set out in Part 4. In broad terms, an applicant must satisfy the Regulator—

(a)

about the quality, safety, and efficacy or performance of the product; and

(b)

that the applicant is a suitable person to hold the approval.

(4)

Once a product is approved, the person to whom the approval is issued (known as the sponsor) is responsible for ensuring that the product complies with its approval and product standards and has ongoing obligations in relation to such things as safety monitoring, record keeping, and reporting (see subpart 3 of Part 4).

(5)

It is also possible for the Regulator to declare a product or class of products to be approval-exempt. Approval-exempt products may be imported or supplied without needing to be approved (see section 51(1)(a)(ii)).

(6)

The sponsor of an approval-exempt product (who will be determined by the Regulator when the product is declared to be approval-exempt) is subject to some of the ongoing obligations that apply to sponsors of approved products (see sections 117 and 118).

(7)

A person may be authorised (by a licence, permit, or provision of subpart 3 of Part 3) to import or supply a product without the product being approved (see section 51(1)(b)). They are authorised to do so only in accordance with the terms and conditions of the authorisation.

10 Controlled activities

(1)

This Act also regulates who is allowed to carry on certain activities involving therapeutic products (called controlled activities) and how those activities are carried on.

(2)

The controlled activities are listed in section 53. The kinds of activities that are regulated include—

(a)

manufacturing:

(b)

wholesale and non-wholesale supply:

(c)

prescribing, administering, and possessing medicines:

(d)

using medical devices and type-4 products on patients:

(e)

issuing standing orders:

(f)

conducting clinical trials:

(g)

carrying on a pharmacy business.

However, exactly what constitutes a controlled activity varies depending on the type and category of product and the circumstances in which the activity is carried on.

(3)

The regulation of controlled activities applies to all therapeutic products, and applies regardless of whether they are approved, approval-exempt, or unapproved.

(4)

It is an offence to carry on a controlled activity unless authorised to do so by a licence, permit, or provision of subpart 3 of Part 3 (see section 53).

(5)

If a product poses a very significant risk of harm, regulations may declare it to be a prohibited product (see section 25). Section 81 then prohibits anyone from importing, manufacturing, supplying, administering or using, or being in possession of it without a permit.

11 Authorisations: subpart 3 of Part 3, licences, and permits

(1)

Subpart 3 of Part 3 authorises people to carry on controlled activities in various circumstances. This includes authorisations for pharmacists, health practitioners, veterinarians, and related workers. Section 79 allows regulations to be made authorising other people to carry on controlled activities.

(2)

Anyone who is covered by an authorisation in subpart 3 of Part 3 may carry on the activity in accordance with the terms of the authorisation without needing a licence or permit.

(3)

A person may be authorised to carry on a controlled activity by a licence or permit. A licence or permit applies only to the controlled activities that are specified in it and only to the therapeutic products that are covered by the licence or permit. A licence or permit is also subject to its terms and conditions (see sections 125 and 133).

(4)

The requirements for getting a licence or permit are set out in Part 5.

(5)

Anyone who is authorised to carry on a controlled activity must also comply with obligations relating to matters such as—

(a)

when, where, and how the activity is carried on:

(b)

packaging and labelling:

(c)

product and consumer information:

(d)

storage, handling, security, transport, and disposal:

(e)

record keeping, auditing, and giving information to the Regulator.

The details of these obligations are set out in the regulations (see section 55).

12 Obligations of other people

(1)

This Act also imposes obligations on people who, in the course of business, import, supply, administer or use on patients, or have possession of any therapeutic products, even if they are not carrying on a controlled activity (see section 55 and the regulations made under it).

(2)

These obligations may relate to the same matters as are referred to in section 11(5), but the obligations on these people are generally less onerous than the obligations of people carrying on controlled activities.

(3)

This Act also imposes restrictions on the advertising of therapeutic products and prohibits things such as tampering with, or making misrepresentations about, therapeutic products (see subpart 4 of Part 3). These provisions apply to everyone.

13 Administration of regulatory scheme

(1)

The regulatory scheme is administered by the chief executive of the Ministry that administers this Act, who is known as the Regulator.

(2)

The Regulator is responsible for approving products, monitoring product safety, licensing, and administering and enforcing this Act.

(3)

The Regulator’s powers and duties are set out in Parts 6 and 7.

Part 2 Interpretation

Subpart 1—General

14 Interpretation

In this Act, unless the context otherwise requires,—

this Act includes the regulations, the rules, and any Regulator’s notices

active moiety, in subpart 4 of Part 4, has the meaning set out in section 120

administer, in relation to a medicine, has the meaning set out in section 26

advertisement has the meaning set out in section 82(1)

advertising remediation order has the meaning set out in section 166(2)

AMI (which is an abbreviation for active medicinal ingredient) has the meaning set out in section 20

analyst means—

(a)

the person designated under section 187(1)(b) as the analyst in charge of a laboratory designated under section 187(1)(a) as a recognised laboratory; or

(b)

a worker nominated under section 187(2) as an analyst

approval, in relation to a therapeutic product, means an approval granted under section 94 for the product, including any conditions to which the approval is subject under section 105

approval-exempt product has the meaning set out in section 24(b)

approved medical device means a medical device that is an approved product

approved medicine means a medicine that is an approved product

approved product has the meaning set out in section 24(a)

approved type-4 product means a type-4 product that is an approved product

authorised prescriber, for a medicine, means—

(a)

a health practitioner prescriber for the medicine; or

(b)

a veterinarian; or

(c)

any other person who is authorised by a licence, permit, or provision of subpart 3 of Part 3 to prescribe the medicine

believe means to believe on reasonable grounds

business means a business, professional practice, or other undertaking, whether or not carried on for gain or reward

category, in relation to a medicine, means a category referred to in section 19

category 1 AMI means an AMI if any medicine containing the AMI is (or, if manufactured, would be) a category 1 medicine

clinical trial has the meaning set out in section 27

complying prescription has the meaning set out in section 38(2)

complying special clinical needs supply authority has the meaning set out in section 39(2)

complying standing order has the meaning set out in section 40(2)

compound has the meaning set out in section 28

controlled activity has the meaning set out in section 53(2)

Customs means the New Zealand Customs Service under the Customs and Excise Act 2018

directions order has the meaning set out in section 168(2)

dispense has the meaning set out in section 29

distribute, in relation to a communication, has the meaning set out in section 82(4)

enforceable undertaking means an undertaking that has been accepted by the Regulator under section 223 and is in force

ethics approval means an approval granted by an ethics approval entity

ethics approval entity means—

(a)

a Health and Disability Ethics Committee established under section 11 of the New Zealand Public Health and Disability Act 2000; or

(b)

a person or body that—

(i)

performs functions similar to those of a committee referred to in paragraph (a); and

(ii)

the Regulator has, by a Regulator’s notice, designated as an ethics approval entity

evidential material, in subpart 2 of Part 6, has the meaning set out in section 183

exemption means an exemption granted under section 264

fit and proper person, see section 47

grounds to cancel, in relation to an approval, has the meaning set out in section 108

grounds to suspend or cancel, in relation to a licence or permit, has the meaning set out in section 141 or 142

harm means harm to personal or community health

health practitioner means a person who—

(a)

is a health practitioner as defined in section 5 of the Health Practitioners Competence Assurance Act 2003; and

(b)

holds a current practising certificate under that Act

health practitioner prescriber, for a medicine, means a health practitioner whose scope of practice includes the prescribing of the medicine

health practitioner worker, in relation to a licensee, means a health practitioner who works for the licensee and, in the course of that work, carries on or does anything authorised by the licence or by a provision of subpart 3 of Part 3

import has the meaning set out in section 30

induce includes to request, instruct, persuade, encourage, assist, or coerce

infringement circumstances has the meaning set out in section 249(1)

infringement fee has the meaning set out in section 250(1)

infringement fine has the meaning set out in section 250(1)

infringement notice means a notice issued under section 253

infringement offence has the meaning set out in section 249(2)

innovative medicine application, in subpart 4 of Part 4, has the meaning set out in section 120

intended for use for a therapeutic purpose has the meaning set out in section 15(2)

intent to deceive includes intent to do 1 or more of the following:

(a)

deceive the Regulator or any other person:

(b)

wrongfully obtain a material benefit or avoid a material detriment:

(c)

frustrate the administration of this Act

investigative purposes, in subpart 2 of Part 6, has the meaning set out in section 183

issuing officer, in subpart 2 of Part 6, has the meaning set out in section 183

level XX offence (where XX is A1, A2, A3, B1, B2, or B3) means a contravention of a provision of this Act that is stated to be a level A1, A2, A3, B1, B2, or B3 offence (because of the circumstances in which it is committed)

licence means a licence granted under section 127

licensee means the holder of a licence

limitation includes a prohibition, restriction, or condition

limited-access medicine has the meaning set out in section 173(2)(a)(i)

limited-access patient has the meaning set out in section 173(2)

major change has the meaning set out in section 100

make publicly available, in relation to the Regulator, has the meaning set out in section 219

manufacture has the meaning set out in section 31(1)

manufacturer has the meaning set out in section 31(2)

medical device has the meaning set out in section 21

medicine has the meaning set out in section 18

medicine access limitation order has the meaning set out in section 173(2)

Ministry means the department (within the meaning of section 27A of the State Sector Act 1988) that, with the authority of the Prime Minister, is responsible for the administration of this Act

misleading information means information that is false, that is misleading in a material particular, or that is misleading because of the omission of a material particular

non-wholesale supply has the meaning set out in section 43(3)

notify means to give notice in writing to a person

opportunity to comment has the meaning set out in section 206

original decision has the meaning set out in section 201

overseas organisation means an overseas or international organisation that has a function relating to therapeutic products, health, or law enforcement

overseas regulator means a body in another country that performs functions that correspond with, or are similar to, any of those of the Regulator under this Act

oversupplied person has the meaning set out in section 172(2)

permit means a permit granted under section 134

permit holder means the holder of a permit

person in the supply chain has the meaning set out in section 44(2)

pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council (as established by section 114(5) of the Health Practitioners Competence Assurance Act 2003) under that Act as a practitioner of the profession of pharmacy

pharmacy activity has the meaning set out in section 36(3)

pharmacy business has the meaning set out in section 36(1)

pharmacy licence means a licence that authorises the licensee to carry on a pharmacy business

pharmacy worker has the meaning set out in section 37(1)

premises restriction order has the meaning set out in section 164(2)

prepare for administration has the meaning set out in section 26(2)

prepare for use has the meaning set out in section 46(2)

prescribe, in relation to a medicine, has the meaning set out in section 38(3)

prescription has the meaning set out in section 38(1)

product prohibition order has the meaning set out in section 170(2)

prohibited product has the meaning set out in section 25

protected active ingredient information, in subpart 4 of Part 4, has the meaning set out in section 120

protection period, in subpart 4 of Part 4, has the meaning set out in section 120

qualified, in relation to a pharmacy worker, has the meaning set out in section 37(2)

recall order has the meaning set out in section 162(2)

regulations means regulations made under section 261

Regulator means the chief executive of the Ministry

Regulator’s Internet site means an Internet site maintained by or on behalf of the Regulator for the purposes of this Act

Regulator’s notice means a notice made under section 263

regulatory entity means any of the following:

(a)

the New Zealand Police:

(b)

the Serious Fraud Office:

(c)

the chief executive of the Ministry (other than in their capacity as the Regulator):

(d)

a responsible authority under the Health Practitioners Competence Assurance Act 2003:

(e)

the Pharmaceutical Management Agency (Pharmac) under the New Zealand Public Health and Disability Act 2000:

(f)

the Health Quality and Safety Commission under the New Zealand Public Health and Disability Act 2000:

(g)

the Inland Revenue Department:

(h)

the Accident Compensation Corporation under the Accident Compensation Act 2001:

(i)

the Health and Disability Commissioner under the Health and Disability Commissioner Act 1994:

(j)

the department in relation to any of the following:

(i)

the Agricultural Compounds and Veterinary Medicines Act 1997:

(ii)

the Biosecurity Act 1993:

(iii)

the Customs and Excise Act 2018:

(iv)

the Food Act 2014:

(v)

the Hazardous Substances and New Organisms Act 1996:

(vi)

the Health Practitioners Competence Assurance Act 2003:

(vii)

the Human Assisted Reproductive Technology Act 2004:

(viii)

the Human Tissue Act 2008:

(ix)

the Misuse of Drugs Act 1975:

(x)

the Psychoactive Substances Act 2013:

(xi)

the Radiation Safety Act 2016

regulatory order means any of the following:

(a)

a recall order:

(b)

a premises restriction order:

(c)

an advertising remediation order:

(d)

a directions order:

(e)

a product prohibition order:

(f)

a medicine access limitation order

relevant thing, in subpart 2 of Part 6, has the meaning set out in section 183

responsible manufacturer has the meaning set out in section 31(3)

responsible person, in relation to a licence, means an individual named in the licence as a responsible person

rules means rules made by the Regulator under section 262

scope of practice, for a health practitioner, means the practitioner’s scope of practice under the Health Practitioners Competence Assurance Act 2003

senior manager has the meaning set out in section 48

special clinical needs supply authority has the meaning set out in section 39(1)

specified fee, for a matter, means the fee (if any) specified for the matter by the regulations referred to in section 257

specified product standard, for a therapeutic product, means the product standards (if any) specified in the rules referred to in section 96 for that product

sponsor,—

(a)

in relation to an approved product, means—

(i)

the person to whom the approval was granted under section 94(3); or

(ii)

if the approval has been transferred under section 102, the person to whom it was transferred:

(b)

in relation to an approval-exempt product, means the person specified as the sponsor in accordance with section 115(1)

standing order has the meaning set out in section 40(1)

state of mind, in relation to a person, includes their knowledge, intention, opinion, belief, or purpose and their reasons for that intention, opinion, belief, or purpose

supply has the meaning set out in section 42

supply chain activity has the meaning set out in section 44(1)

supply-restricted device has the meaning set out in section 22(1)

supply restriction has the meaning set out in section 22(1)

take overseas has the meaning set out in section 45

tamper with has the meaning set out in section 84(1)

therapeutic product has the meaning set out in section 16

therapeutic purpose has the meaning set out in section 15

type, in relation to a therapeutic product, means a type of therapeutic product specified in section 17

type-4 product has the meaning set out in section 23

unapproved product has the meaning set out in section 24(c)

unprofessional, in relation to a health practitioner, means not in accordance with the standards of clinical competence, cultural competence, and ethical conduct set under section 118(i) of the Health Practitioners Competence Assurance Act 2003 by the authority for the practitioner’s profession

use, in relation to a medical device or type-4 product, has the meaning set out in section 46(1)

use-restricted device has the meaning set out in section 22(2)

use restriction has the meaning set out in section 22(2)

veterinarian has the same meaning as in section 4 of the Veterinarians Act 2005

wholesale supply has the meaning set out in section 43(2)

work has the meaning set out in section 49(1)

worker has the meaning set out in section 49(2).

Subpart 2—Therapeutic products

15 Meaning of therapeutic purpose

(1)

The following are therapeutic purposes:

(a)

preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect, or injury:

(b)

influencing, inhibiting, or modifying a human physiological process:

(c)

testing the susceptibility of humans to a disease or an ailment:

(d)

influencing, controlling, or preventing human conception:

(e)

testing for human pregnancy:

(f)

investigating, replacing, modifying, or supporting part of a human’s anatomy:

(g)

supporting or sustaining human life:

(h)

disinfecting medical devices:

(i)

a purpose connected with a purpose referred to in paragraphs (a) to (h).

(2)

Something is intended for use for a therapeutic purpose if it is, or is in a class of things that are,—

(a)

ordinarily used for that purpose; or

(b)

intended by the responsible manufacturer to be used for that purpose; or

(c)

represented as being for use for that purpose; or

(d)

likely (because of the way in which it is presented or for any other reason) to be used for that purpose.

16 Meaning of therapeutic product

(1)

A product is a therapeutic product if—

(a)

it is intended for use in, on, or in relation to humans for a therapeutic purpose; or

(b)

it is specified in the regulations to be a therapeutic product; or

(c)

it—

(i)

is not a therapeutic product under paragraph (a) or (b); but

(ii)

is intended for use as an active ingredient of a medicine.

(2)

A naturally occurring thing that might not otherwise be considered to be a product may become a product if it is changed from its naturally occurring state (and, having become a product, if subsection (1)(a), (b), or (c) applies to it, it would be a therapeutic product).

Example

Human blood is not generally regarded as a product. However, if a person donates blood to the NZ Blood Service, the collected blood would become a product. As the donated blood is intended for use for a therapeutic purpose, it would be a therapeutic product.

(3)

However, a product that would otherwise be a therapeutic product under subsection (1)(a) is not a therapeutic product if it is a natural health product.

[Note for consultation draft: The government is considering options for the regulation of natural health products and intends to exclude them from the Bill. However, the definition of natural health product and the exact mechanism by which they will be excluded from the Bill are yet to be determined. Exclusion from the definition of therapeutic product, as provided by subsection (3), is one of the options being considered.]

(4)

A product that would otherwise be a therapeutic product under subsection (1)(a) or (c) is not a therapeutic product if it is specified in the regulations to not be a therapeutic product.

17 Types of therapeutic products

There are 4 types of therapeutic products—

(a)

medicines:

(b)

AMIs:

(c)

medical devices:

(d)

type-4 products.

18 Meaning of medicine

(1)

A therapeutic product is a medicine if—

(a)

it—

(i)

is a therapeutic product under section 16(1)(a) or (b); and

(ii)

achieves, or is likely to achieve, its principal intended action—

(A)

by pharmacological, immunological, or metabolic means; or

(B)

by means of the action of something that comprises, contains, or is derived from human or animal cells or tissues; or

(b)

it is specified in a Regulator’s notice to be a medicine.

(2)

However, a therapeutic product that would otherwise be a medicine under subsection (1)(a) is not a medicine if it is specified in a Regulator’s notice to be an AMI, a medical device, or a type-4 product.

19 Categories of medicine

(1)

There are 4 categories of medicines, being categories 1, 2, 3, and 4.

(2)

The regulations must provide for the categorisation of medicines (and must do so in a way that results in every medicine being in one of the 4 categories).

(3)

The regulations may provide for the Regulator to categorise medicines by Regulator’s notice.

(4)

A reference to a category X medicine (where X is the number 1, 2, 3, or 4) is a reference to a medicine that is in the category of that number.

20 Meaning of AMI (active medicinal ingredient)

(1)

A therapeutic product is an AMI if—

(a)

it is a therapeutic product under section 16(1)(c); or

(b)

it is specified in a Regulator’s notice to be an AMI.

(2)

However, a therapeutic product that would otherwise be an AMI under subsection (1)(a) is not an AMI if it is specified in a Regulator’s notice to be a medicine, a medical device, or a type-4 product.

21 Meaning of medical device

(1)

A therapeutic product is a medical device if—

(a)

it—

(i)

is a therapeutic product under section 16(1)(a) or (b); and

(ii)

achieves, or is likely to achieve, its principal intended action by means other than—

(A)

pharmacological, immunological, or metabolic means; or

(B)

the action of something that comprises, contains, or is derived from human or animal cells or tissues;

(although its function may be assisted by pharmacological, immunological, or metabolic processes or by the action of something that comprises, contains, or is derived from human or animal cells or tissues); or

(b)

it is specified in a Regulator’s notice to be a medical device.

(2)

However, a therapeutic product that would otherwise be a medical device under subsection (1)(a) is not a medical device if it is specified in a Regulator’s notice to be a medicine, an AMI, or a type-4 product.

22 Supply-restricted devices and use-restricted devices

(1)

A medical device is a supply-restricted device if the regulations—

(a)

declare it to be a supply-restricted device; and

(b)

specify restrictions that apply to the non-wholesale supply of the device (supply restrictions).

(2)

A medical device is a use-restricted device if the regulations—

(a)

declare it to be a use-restricted device; and

(b)

specify restrictions that apply to the use of the device on persons (use restrictions).

(3)

Regulations specifying supply or use restrictions may (without limitation) relate to any of the following:

(a)

persons who may, or must not, supply or use the device:

(b)

circumstances in which the device may, or must not, be supplied or used:

(c)

how the device may, or must not, be supplied or used.

23 Meaning of type-4 product

A therapeutic product is a type-4 product if it is specified in a Regulator’s notice to be a type-4 product.

24 Meanings of approved product, approval-exempt product, and unapproved product

A medicine, medical device, or type-4 product is—

(a)

an approved product if it is approved under subpart 1 of Part 4 and is not a prohibited product; or

(b)

an approval-exempt product if it is declared to be an approval-exempt product under section 114 and is not a prohibited product; or

(c)

an unapproved product if it is not an approved product, an approval-exempt product, or a prohibited product.

25 Meaning of prohibited product

(1)

A therapeutic product is a prohibited product if it is specified in the regulations to be a prohibited product.

(2)

The Minister must not recommend the making of regulations specifying a product to be a prohibited product unless satisfied that—

(a)

the product poses a significant risk of death or serious harm; and

(b)

that risk cannot be adequately managed by the exercise of the Regulator’s powers under this Act.

Subpart 3—Activities

26 Meanings of administer and prepare for administration

(1)

To administer a medicine means to do either or both of the following:

(a)

prepare the medicine for administration:

(b)

administer the medicine to a person or an animal—

(i)

by introducing it into their body (orally, by injection, or in any other way); or

(ii)

by external application.

(2)

To prepare for administration, in relation to a medicine, includes the following:

(a)

to dissolve, disperse, dilute, or mix the medicine in or with another substance as an administration medium:

(b)

to mix the medicine with another medicine to be administered at the same time.

27 Meaning of clinical trial

A clinical trial of a therapeutic product means an investigation—

(a)

that involves administering the product to, or using it on, 1 or more individuals (subjects); and

(b)

that is undertaken to obtain information about,—

(i)

for a medicine, its quality, safety, or efficacy or performance by doing 1 or more of the following:

(A)

discovering or verifying its clinical, pharmacological, or other pharmacodynamic effects:

(B)

identifying any adverse reactions to it:

(C)

studying its absorption, distribution, metabolism, or excretion; or

(ii)

for a medical device or type-4 product, its quality, safety, or efficacy or performance; and

(c)

to which 1 or more of the following apply:

(i)

the assignment of each subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice:

(ii)

the decision to administer or use the product is taken together with the decision to include the subject in the study:

(iii)

diagnostic or monitoring procedures additional to those used in normal clinical practice are applied to the subjects.

28 Meaning of compound

(1)

To compound a medicine means to produce a permitted quantity of the medicine ready for supply to a particular identified patient in response to a request for that supply.

(2)

A permitted quantity of a medicine means,—

(a)

if the rules specify a maximum compoundable quantity for the medicine, an amount that does not exceed the specified quantity; or

(b)

otherwise, not more than the patient reasonably needs for the period in respect of which the medicine is to be supplied.

(3)

Compounding a medicine is part of manufacturing the medicine (see section 32(2)).

29 Meaning of dispense

(1)

To dispense a medicine means to bring the medicine to a state ready for immediate supply to a particular identified patient in response to a request for that supply.

(2)

Preparing a medicine for immediate administration is not dispensing.

(3)

Dispensing a medicine is part of manufacturing the medicine (see section 32(2)).

30 Meaning of import

(1)

To import a therapeutic product means to bring the product into New Zealand.

(2)

If a therapeutic product is imported, each of the following are taken to import it:

(a)

a person who does the physical activity of importing the product:

(b)

a person who arranges for, or causes, the product to be imported:

(c)

a consignee of the product:

(d)

a person who—

(i)

owns, has a beneficial interest in, or is entitled to possession of, the product at the time it is imported; or

(ii)

becomes the owner of, entitled to possession of, or beneficially interested in the product while it is subject to the control of Customs (as defined in section 6 of the Customs and Excise Act 2018).

31 Meanings of manufacture, manufacturer, and responsible manufacturer

(1)

To manufacture a therapeutic product has the meaning set out in,—

(a)

for a medicine, section 32:

(b)

for an AMI, section 33:

(c)

for a medical device, section 34:

(d)

for a type-4 product, section 35.

(2)

A person is a manufacturer of a therapeutic product if the person does anything that is part of manufacturing the product.

(3)

The responsible manufacturer of a therapeutic product is the person who is in fact primarily responsible for the manufacture of the product.

(4)

In determining who is the responsible manufacturer of a medicine or an AMI, the following are relevant considerations:

(a)

who transforms the starting materials into the final product:

(b)

who is responsible for overall quality assurance and quality control in relation to the manufacture of the product:

(c)

if the product is, or is intended to be, released into the supply chain, whose name or trade mark the product is, or is to be, supplied under.

(5)

In determining who is the responsible manufacturer of a medical device or type-4 product—

(a)

a person may be the responsible manufacturer whether or not they personally undertake the manufacture of the product; and

(b)

the following are relevant considerations:

(i)

who initiated the manufacture of the product:

(ii)

if the product is, or is intended to be, released into the supply chain, whose name or trade mark the product is, or is to be, supplied under:

(iii)

who is responsible for overall quality assurance and quality control in relation to the manufacture of the product.

(6)

The matters listed in subsections (4)(a) to (c) and (5)(b)

(a)

are relevant but not determinative considerations; and

(b)

do not limit the matters that may be taken into account in determining who is the responsible manufacturer of a product.

(7)

If a medical device is remanufactured (as defined in section 34(4)),—

(a)

the person who was the responsible manufacturer of the original device ceases to be the responsible manufacturer; and

(b)

the person who is primarily responsible for the remanufacture is the responsible manufacturer of the remanufactured device.

32 Meaning of manufacture, for medicine

(1)

To manufacture a medicine means—

(a)

to produce the medicine; or

(b)

to do anything that is part of the process of—

(i)

producing the medicine; or

(ii)

bringing the medicine to its final state (including testing, sterilising, releasing for supply, packaging, or labelling the medicine).

Compounding or dispensing part of manufacture

(2)

Compounding or dispensing a medicine is part of manufacturing the medicine.

Preparing for administration not part of manufacture

(3)

Preparing a medicine for administration is not part of manufacturing the medicine if the preparation is done—

(a)

in accordance with the responsible manufacturer’s product information; or

(b)

by, or in accordance with the directions of, an authorised prescriber for the medicine.

Cell and tissue medicines

(4)

In relation to a medicine that comprises, contains, or is derived from human or animal cells or tissues, to manufacture the medicine includes the following—

(a)

to procure the cells or tissues (including to remove them from their natural state so as to make them into a product (see section 16(2))):

(b)

to test, preserve, or bank or otherwise store the cells or tissues or their derivatives:

(c)

to process, engineer, or otherwise modify the cells or tissues or their derivatives.

33 Meaning of manufacture, for AMI

To manufacture an AMI means—

(a)

to produce the AMI; or

(b)

to do anything that is part of the process of—

(i)

producing the AMI; or

(ii)

bringing the AMI to its final state ready for use in the manufacture of medicines (including testing, sterilising, releasing for supply, packaging, or labelling the AMI).

34 Meaning of manufacture, for medical device

(1)

To manufacture a medical device means—

(a)

to produce the device; or

(b)

to do anything that is part of the process of—

(i)

producing the device; or

(ii)

bringing the device to its final state (including testing, sterilising, releasing for supply, packaging, or labelling the device); or

(c)

to do anything that is part of the process of remanufacturing the device.

Software

(2)

In relation to a device that is or includes software, to produce the device includes to develop the software.

Preparing for use not part of manufacture

(3)

If a medical device has been supplied by its responsible manufacturer as being in its final state but needs to be prepared for use, preparing it for use is not part of manufacturing the device if the preparation—

(a)

is done in accordance with the responsible manufacturer’s product information; and

(b)

does not constitute remanufacturing the device.

Remanufacture

(4)

If a medical device has been supplied by its responsible manufacturer as being in its final state (whether or not it has been used), to remanufacture the device means to alter, refurbish, recondition, or otherwise further process the device so as to—

(a)

change the purpose for which it is intended to be used; or

(b)

enable it to be used in a way that is materially different from that intended by the responsible manufacturer of the original device; or

(c)

if it was originally manufactured as a single-use-only device, enable it to be re-used; or

(d)

make it into a different medical device; or

(e)

make any other change to it that would be a major change if it were an approved product.

(5)

However, a person does not remanufacture a medical device (other than a single-use only device) merely by cleaning it, carrying out repairs and maintenance, or undertaking similar processes, to enable the continued use of the device in the originally intended manner.

35 Meaning of manufacture, for type-4 product

(1)

To manufacture a type-4 product means—

(a)

to produce the product; or

(b)

to do anything that is part of the process of—

(i)

producing the product; or

(ii)

bringing the product to its final state (including testing, sterilising, releasing for supply, packaging, or labelling the product).

(2)

Preparing a type-4 product for use is not part of manufacturing the product if the preparation is done in accordance with the responsible manufacturer’s product information.

36 Meanings of pharmacy business and pharmacy activity

(1)

A business is a pharmacy business if its activities include 1 or more of the following:

(a)

compounding medicines for non-wholesale supply:

(b)

dispensing medicines for non-wholesale supply:

(c)

supplying category 1 or 2 medicines by non-wholesale supply.

(2)

However, a business is not a pharmacy business if—

(a)

it is the professional practice of a health practitioner or veterinarian in which medicines are dispensed or supplied under the authorisations provided by sections 61 to 70; or

(b)

it is a business of a kind specified in the regulations not to be a pharmacy business.

(3)

For a pharmacy business, the following are pharmacy activities:

(a)

the activities listed in subsection (1):

(b)

supplying category 3 medicines by non-wholesale supply:

(c)

supplying medicines and medical devices by wholesale supply in circumstances permitted by the regulations.

(4)

If a business is a pharmacy business under subsection (1), then all of the pharmacy activities it carries on are taken to be part of the pharmacy business (and therefore subject to the terms and conditions of the licence).

(5)

However, if the business also carries on other activities that are not pharmacy activities, the business is only a pharmacy business to the extent of its pharmacy activities.

37 Meanings of pharmacy worker and qualified

(1)

A pharmacy worker is a person who works in a pharmacy business but is not a pharmacist.

(2)

A pharmacy worker is qualified to carry on a pharmacy activity in relation to a medicine if the worker meets the qualification, training, and competency requirements specified in the rules for that pharmacy activity in relation to that medicine.

(3)

The rules may specify either or both of the following:

(a)

qualification, training, and competency requirements for pharmacy workers:

(b)

levels of supervision under which a qualified pharmacy worker may carry on pharmacy activities (for the purposes of section 60).

38 Meanings of prescription, complying prescription, and prescribe

(1)

A prescription is a direction that sets out details of a particular medicine that is to be administered by or to a particular identified person or animal (the patient).

(2)

A prescription for a medicine is a complying prescription if—

(a)

it is issued by a person who is authorised to issue it; and

(b)

it is made in accordance with any requirements for complying prescriptions specified in the regulations; and

(c)

no expiry event specified in the regulations has occurred in relation to it.

(3)

To prescribe a medicine means to issue a prescription for that medicine.

(4)

Subject to the regulations, a prescription may be issued orally, in writing, or in any other form.

(5)

A person does not issue a prescription merely by doing either of the following:

(a)

making a record of a prescription that was issued orally:

(b)

after supplying some but not all of the medicine specified in a prescription, making a record setting out that the rest of the medicine remains to be supplied.

(6)

Regulations for the purposes of subsection (2)(b) may (without limitation) relate to any of the following:

(a)

circumstances in which a prescription may, or must not, be issued:

(b)

the form of a prescription:

(c)

the content of a prescription:

(d)

how a prescription is to be issued.

39 Meanings of special clinical needs supply authority and complying special clinical needs supply authority

(1)

A special clinical needs supply authority is a document that—

(a)

states that the person issuing it has determined that a particular identified person or animal (the patient) has a special clinical need for a specified unapproved product; and

(b)

is issued for the purpose of enabling the procurement and supply of that product to meet that need.

(2)

A special clinical needs supply authority is a complying special clinical needs supply authority if—

(a)

it is issued by a person who is authorised to issue it; and

(b)

it is made in accordance with any requirements for complying special clinical needs supply authorities in the regulations; and

(c)

no expiry event specified in the regulations has occurred in relation to it.

(3)

Regulations for the purposes of subsection (2)(b) may (without limitation) relate to any of the following:

(a)

circumstances in which a special clinical needs supply authority may, or must not, be issued:

(b)

the form of a special clinical needs supply authority:

(c)

the content of a special clinical needs supply authority:

(d)

how a special clinical needs supply authority is to be issued.

40 Meanings of standing order and complying standing order

(1)

A standing order is an order that authorises a person to do 1 or more of the following:

(a)

supply an approved or approval-exempt category 1, 2, or 3 medicine by non-wholesale supply (for the purposes of section 53(1) and (2)(c)(i) and (ii)):

(b)

supply an approved or approval-exempt category 1 medicine by non-wholesale supply without a prescription (for the purposes of section 54):

(c)

administer an approved or approval-exempt category 1 medicine (for the purposes of section 53(1) and (2)(f)).

(2)

A standing order is a complying standing order if—

(a)

it is issued by a person who is authorised to issue it; and

(b)

it is made in accordance with any requirements for complying standing orders in the regulations.

(3)

Regulations for the purposes of subsection (2)(b) may (without limitation) relate to any of the following:

(a)

circumstances in which a standing order may, or must not, be issued:

(b)

the form of a standing order:

(c)

the content of a standing order:

(d)

how a standing order is to be issued.

41 Effect of complying standing order

(1)

A complying standing order—

(a)

takes effect at the time it is made; and

(b)

remains in force until the first of the following occurs:

(i)

if it includes an expiry date, the end of that day:

(ii)

the issuer of the order revokes it:

(iii)

a revocation event specified in the regulations.

(2)

A complying standing order authorises a person specified in it to supply or administer (as specified in the order) an approved or approval-exempt medicine specified in the order in accordance with the terms and conditions of the order.

(3)

However, a complying standing order has effect subject to the regulations.

(4)

Regulations for the purposes of subsection (3) may (without limitation) relate to any of the following:

(a)

the effect of a complying standing order if the issuer ceases to be authorised to issue it:

(b)

the effect of a complying standing order if a person authorised by the order ceases to be a person who may be authorised by an order:

(c)

whether a complying standing order may be issued by a person in their capacity as the holder of a particular office or position and, if so, the effect of their ceasing to hold that office or position.

(5)

For the purposes of sections 239 to 241, a person who is authorised by a complying standing order to do something is taken to be the agent of the person who issued the order.

42 Meaning of supply

(1)

To supply a therapeutic product means to supply the therapeutic product to another person (whether that person is in New Zealand or elsewhere).

(2)

If a person sends a therapeutic product from a place in New Zealand to themselves at a place outside New Zealand, they are taken to supply the product (even though the supplier and recipient are the same person).

(3)

However, supply does not include administering a medicine or using a medical device or type-4 product on a patient.

(4)

In determining whether a person has supplied a therapeutic product, the following are immaterial:

(a)

the quantity of the product:

(b)

the purpose for which the product is supplied:

(c)

whether the recipient pays for, or gives something in exchange for, the product or is liable to do so:

(d)

whether the recipient acquires legal title to the product or only an entitlement to use it (for example, under a lease, hire-purchase, sharing agreement, or other arrangement):

(e)

whether the supplier and recipient are in the same place at the same time:

(f)

how the therapeutic product is supplied.

(5)

A person (the supplier) supplies a therapeutic product to a particular person (the recipient) if the supplier supplies the product—

(a)

to the recipient in person; or

(b)

to a person who has lawful authority to receive the product for the recipient.

(6)

If a patient is an animal, a reference to supplying a therapeutic product to the patient is a reference to supplying it to an owner or a carer of the animal.

43 Meanings of wholesale supply and non-wholesale supply

(1)

There are 2 kinds of supply of therapeutic products—wholesale and non-wholesale.

(2)

The supply of a medicine, medical device, or type-4 product is wholesale supply if the product is supplied in circumstances in which in would be reasonable for the supplier to believe that the recipient is obtaining the product for 1 or more of the following purposes:

(a)

to supply it to other persons in the course of the recipient’s business:

(b)

to administer it, or use it on patients, in the course of the recipient’s business:

(c)

to use it in a scientific, educational, or commercial laboratory:

(d)

to use it in a manufacturing or trade process.

(3)

Any supply of a medicine, medical device, or type-4 product that is not wholesale supply (for example, retail sale or supply to patients) is non-wholesale supply.

(4)

In relation to an AMI, any supply of the product is wholesale supply.

44 Meanings of supply chain activity and person in the supply chain

(1)

Each of the following is a supply chain activity:

(a)

a controlled activity:

(b)

doing any of the following in the course of business in circumstances that do not constitute carrying on a controlled activity:

(i)

importing a therapeutic product:

(ii)

supplying a therapeutic product:

(iii)

administering a medicine:

(iv)

using a medical device or type-4 product on a person or an animal:

(v)

taking a therapeutic product overseas:

(vi)

being in possession of a therapeutic product.

(2)

A person who carries on a supply chain activity is a person in the supply chain.

45 Meaning of take overseas

To take overseas a therapeutic product means to take the product from a place in New Zealand to a place outside New Zealand in circumstances that do not constitute supply of the product.

46 Meanings of use and prepare for use

(1)

To use a medical device or type-4 product means to do either or both of the following:

(a)

prepare the device or product for use:

(b)

use the device or product for a therapeutic purpose in, on, or in relation to, a person or animal.

(2)

In relation to a medical device or type-4 product, to prepare for use includes the following:

(a)

to assemble the device or product:

(b)

to calibrate or adjust the device or product before putting it into service or for a particular patient.

Subpart 4—Miscellaneous

47 Fit and proper person

(1)

In determining whether a person (person A) is a fit and proper person for any purpose under this Act, the Regulator must have regard to the following:

(a)

any conviction of person A for an offence in New Zealand or another country:

(b)

if person A holds or has held a licence, permit, approval, registration, exemption, or other authorisation under a relevant law (an authority)—

(i)

any suspension or revocation of the authority:

(ii)

any enforcement or disciplinary action taken against person A in relation to the authority:

(iii)

any disqualification from holding the authority or any other authority under the relevant law:

(iv)

any contravention by person A of—

(A)

the terms and conditions of the authority; or

(B)

a provision of a relevant law that applied to person A as the holder of the authority:

(c)

whether there are other grounds for believing that person A is likely in future to contravene a provision of this Act:

(d)

whether person A is or has been—

(i)

bankrupt; or

(ii)

subject to an insolvency event (as defined in section 6(4) of the Financial Markets Conduct Act 2013) or to an equivalent event under a law of another country:

(e)

whether person A is otherwise of good character:

(f)

any other matters that the Regulator considers relevant.

(2)

In subsection (1)(a) to (e), a reference to person A includes a reference to each person—

(a)

who is or has been a senior manager of person A; or

(b)

of whom person A is or has been a senior manager.

(3)

In this section, relevant law means any of the following Acts (or regulations made under them)—

(a)

this Act:

(b)

the Agricultural Compounds and Veterinary Medicines Act 1997:

(c)

the Biosecurity Act 1993:

(d)

the Customs and Excise Act 2018:

(e)

the Food Act 2014:

(f)

the Hazardous Substances and New Organisms Act 1996:

(g)

the Health Practitioners Competence Assurance Act 2003:

(h)

the Human Assisted Reproductive Technology Act 2004:

(i)

the Human Tissue Act 2008:

(j)

the Medicines Act 1981 (repealed):

(k)

the Misuse of Drugs Act 1975:

(l)

the Psychoactive Substances Act 2013:

(m)

the Radiation Safety Act 2016:

(n)

a law of the Commonwealth of Australia or a State or Territory of Australia that corresponds to all or part of this Act.

48 Meaning of senior manager

A person (person A) is a senior manager of another person (person B) if—

(a)

person A is a director of person B (as defined in section 6(1) of the Financial Markets Conduct Act 2013); or

(b)

person A occupies a position in relation to person B that allows person A to exercise significant influence over the management or administration of person B (for example, a chief executive or a chief financial officer); or

(c)

person A is otherwise able, whether directly or through 1 or more interposed entities, to exercise significant influence over the management or administration of person B.

49 Meanings of work and worker

(1)

To work in a business or for a person means to carry out work in any capacity in the business or for the person, including work as any of the following:

(a)

an employee:

(b)

a contractor or subcontractor:

(c)

an employee of a contractor or subcontractor:

(d)

an employee of a labour hire company who has been assigned to work in the business or for the person:

(e)

an apprentice, a trainee, or a student undertaking practical training.

(2)

A worker means—

(a)

in relation to a business, a person who works in the business:

(b)

in relation to a licence or permit, a person who works for the licensee or permit holder or otherwise in the business to which the licence or permit relates:

(c)

in relation to a health practitioner or a veterinarian, a person who works for, or in the same business as, the health practitioner or veterinarian.

50 Examples

An example in this Act has the following status:

(a)

the example is only illustrative of the provision to which it relates and does not limit the provision; and

(b)

if the example and the provision to which it relates are inconsistent, the provision prevails.

Part 3 Dealing with therapeutic products

Subpart 1—Product approval requirements

51 Product approval required to import or supply medicine, medical device, or type-4 product

(1)

A person must not import or supply a medicine, medical device, or type-4 product unless—

(a)

the product is—

(i)

an approved product; or

(ii)

an approval-exempt product; or

(b)

the person is authorised by a licence, permit, or provision of subpart 3 of Part 3 to import or supply the product without it being approved.

(2)

If a person contravenes subsection (1) in circumstances that are not infringement circumstances,—

(a)

if they do so wilfully, they commit a level A1 offence; or

(b)

if they do so recklessly, they commit a level A2 offence; or

(c)

otherwise, they commit a level A3 offence.

(3)

A person who commits an offence under subsection (2) is liable on conviction to the appropriate penalty set out in section 233.

(4)

A person who contravenes subsection (1) in infringement circumstances commits an infringement offence and is liable to an infringement fee or a fine as set out in section 251.

52 Sponsor’s consent required to import approved product

(1)

A person must not import an approved product unless they—

(a)

are the product’s sponsor; or

(b)

import the product with the written consent of the sponsor; or

(c)

are authorised by a licence, permit, or provision of subpart 3 of Part 3 to import the product without the sponsor’s consent.

(2)

If a person contravenes subsection (1) in circumstances that are not infringement circumstances,—

(a)

if they do so wilfully, they commit a level A1 offence; or

(b)

if they do so recklessly, they commit a level A2 offence; or

(c)

otherwise, they commit a level A3 offence.

(3)

A person who commits an offence under subsection (2) is liable on conviction to the appropriate penalty set out in section 233.

(4)

A person who contravenes subsection (1) in infringement circumstances commits an infringement offence and is liable to an infringement fee or a fine as set out in section 251.

Subpart 2—Controlled activities and supply chain activities

53 Authorisation required for controlled activity

(1)

A person must not carry on a controlled activity unless they are authorised to do so by a licence, permit, or provision of subpart 3 of Part 3.

(2)

Each of the following is a controlled activity:

(a)

manufacturing a therapeutic product (which, for medicines, includes compounding and dispensing):

(b)

the wholesale supply of—

(i)

a medical device:

(ii)

a category 1, 2, or 3 medicine:

(iii)

a category 1 AMI:

(iv)

a type-4 product:

(c)

the non-wholesale supply of—

(i)

a category 1 medicine:

(ii)

a category 2 or 3 medicine in the course of business:

(iii)

a supply-restricted device contrary to supply restrictions:

(iv)

a type-4 product:

(d)

prescribing a medicine:

(e)

issuing a special clinical needs supply authority for a therapeutic product:

(f)

administering a category 1 medicine:

(g)

possessing—

(i)

a category 1 medicine:

(ii)

a category 1 AMI:

(h)

taking overseas in the course of business:

(i)

a category 1, 2, or 3 medicine:

(ii)

a category 1 AMI:

(i)

issuing a standing order in relation to a medicine:

(j)

using a use-restricted device on a person contrary to use restrictions:

(k)

using a type-4 product on a person or animal in the course of business:

(l)

conducting a clinical trial of a therapeutic product:

(m)

carrying on a pharmacy business.

(3)

If a person contravenes subsection (1) in circumstances that are not infringement circumstances,—

(a)

if they do so wilfully, they commit a level A1 offence; or

(b)

if they do so recklessly, they commit a level A2 offence; or

(c)

otherwise, they commit a level A3 offence.

(4)

A person who commits an offence under subsection (3) is liable on conviction to the appropriate penalty set out in section 233.

(5)

A person who contravenes subsection (1) in infringement circumstances commits an infringement offence and is liable to an infringement fee or a fine as set out in section 251.

54 Non-wholesale supply of category 1 medicine: prescription required

(1)

A person must not supply a category 1 medicine by non-wholesale supply unless they—

(a)

supply it in accordance with a complying prescription to the patient for whom it is prescribed; or

(b)

are an authorised prescriber for the medicine; or

(c)

are authorised by a licence, permit, or provision of subpart 3 of Part 3 to supply it without a complying prescription.

(2)

If a person contravenes subsection (1),—

(a)

if they do so wilfully, they commit a level A1 offence; or

(b)

if they do so recklessly, they commit a level A2 offence; or

(c)

otherwise, they commit a level A3 offence.

(3)

A person who commits an offence under subsection (2) is liable on conviction to the appropriate penalty set out in section 233.

55 Persons in supply chain must comply with regulations

(1)

A person in the supply chain must comply with any requirements specified in the regulations in relation to any of the following:

(a)

if the person carries on a controlled activity, how that activity is carried on (see subsection (2)):

(b)

product and consumer information for therapeutic products:

(c)

packaging and labelling for therapeutic products:

(d)

storage, handling, security, transport, and disposal of therapeutic products:

(e)

tracing and recall of therapeutic products (see subsection (4)):

(f)

record keeping, auditing, and giving information to the Regulator:

(g)

in relation to the issuing of a standing order or special clinical needs supply authority, ongoing monitoring by the issuer of conduct authorised by the order or authority (see subsection (5)).

(2)

Regulations specifying how a controlled activity is carried on may (without limitation) relate to any of the following:

(a)

when, where, and how the activity is carried on:

(b)

the premises, equipment, and materials used in carrying on the activity:

(c)

the processes, practices, methods, and procedures used in carrying on the activity:

(d)

quality control and assurance in relation to the carrying on of the activity:

(e)

the qualification, training, and competency of persons involved in carrying on the activity.

(3)

In relation to supplying, prescribing, or administering a medicine, or the supply or use of a medical device or type-4 product, regulations for the purposes of subsection (2)(a) may (without limitation) relate to any of the following:

(a)

the circumstances in which a therapeutic product may, or must not, be supplied, prescribed, administered, and used:

(b)

the persons by whom a therapeutic product may, or must not, be supplied, prescribed, administered, and used:

(c)

the supply, administration, and use of damaged therapeutic products:

(d)

the supply, administration, and use of therapeutic product after their expiry date.

(4)

Regulations specifying tracing and recall requirements may (without limitation) relate to any of the following:

(a)

having in place procedures for tracing and recalling therapeutic products:

(b)

conducting simulations or other tests of those procedures:

(c)

implementing those procedures to trace or recall therapeutic products:

(d)

responding to recall orders:

(e)

how recalled products are dealt with.

(5)

Regulations specifying ongoing monitoring requirements for standing orders or special clinical needs supply authorities may (without limitation) relate to monitoring and reviewing any of the following:

(a)

the need for the standing order or special clinical needs supply authority:

(b)

the appropriateness of the terms of the order or authority:

(c)

the conduct of persons exercising authority under the order or authority.

(6)

If a person in the supply chain contravenes subsection (1) in circumstances that are not infringement circumstances,—

(a)

if they do so wilfully, they commit a level A1 offence; or

(b)

if they do so recklessly, they commit a level A2 offence; or

(c)

otherwise, they commit a level A3 offence.

(7)

A person who commits an offence under subsection (6) is liable on conviction to the appropriate penalty set out in section 233.

(8)

A person in the supply chain who contravenes subsection (1) in infringement circumstances commits an infringement offence and is liable to an infringement fee or a fine as set out in section 251.

Subpart 3—Authorisations

56 Effect of this subpart

(1)

The provisions of this subpart authorise persons to do things for the purposes of particular provisions of subparts 1 and 2.

(2)

A person who is authorised for the purposes of a particular provision is still required to comply with all other provisions of subparts 1 and 2 that are applicable to them. This includes complying with the regulations made for the purposes of section 55.

57 Pharmacists: approved and approval-exempt medicines
Dispensing

(1)

For the purposes of section 53(1) and (2)(a), a pharmacist may dispense an approved or approval-exempt medicine if—

(a)

the pharmacist complies with the licence requirements in subsection (3); and

(b)

if it is a category 1 medicine, the medicine is dispensed in accordance with a complying prescription.

Non-wholesale supply of category 1, 2, or 3 medicine

(2)

For the purposes of section 53(1) and (2)(c)(i) and (ii), a pharmacist may supply an approved or approval-exempt category 1, 2, or 3 medicine by non-wholesale supply if—

(a)

the pharmacist complies with the licence requirements in subsection (3); and

(b)

if it is a category 2 medicine, the medicine is supplied—

(i)

in accordance with a complying prescription; or

(ii)

after the pharmacist has determined that the medicine is appropriate for the patient.

(3)

The licence requirements for a pharmacist, in relation to a controlled activity, are that the pharmacist—

(a)

is working in a licensed pharmacy business; and

(b)

carries on the activity at a place—

(i)

specified in the licence as one at which the activity may be carried on; or

(ii)

at which the regulations permit the activity to be carried on; and

(c)

otherwise carries on the activity in accordance with the terms and conditions of the licence.

58 Pharmacists: unapproved products
Compounding

(1)

For the purposes of section 53(1) and (2)(a), a pharmacist may compound an unapproved medicine if—

(a)

the pharmacist complies with the licence requirements in section 57(3); and

(b)

if it is a category 1 medicine, the medicine is compounded in accordance with a complying prescription.

Non-wholesale supply of category 1, 2, or 3 medicine and dispensing

(2)

For the purposes of sections 51 and 53, a pharmacist may carry on a controlled activity referred to in section 57 in relation to an unapproved medicine if—

(a)

the pharmacist would be authorised by section 57 to do so if the medicine were an approved medicine; and

(b)

either—

(i)

there is a complying special clinical needs supply authority for the patient for that medicine; or

(ii)

the medicine was lawfully compounded for the patient.

Non-wholesale supply of category 4 medicine

(3)

For the purposes of section 51, a pharmacist may supply an unapproved category 4 medicine by non-wholesale supply if—

(a)

the pharmacist complies with the licence requirements in section 57(3); and

(b)

either—

(i)

there is a complying special clinical needs supply authority for the patient for that medicine; or

(ii)

the medicine was lawfully compounded for the patient.

Non-wholesale supply of medical device

(4)

For the purposes of section 51, a pharmacist may supply an unapproved medical device by non-wholesale supply if—

(a)

the pharmacist complies with the licence requirements in section 57(3); and

(b)

there is a complying special clinical needs supply authority for the patient for that device.

Importing

(5)

For the purposes of section 51, a pharmacist may import an unapproved medicine or medical device if—

(a)

the pharmacist complies with the licence requirements in section 57(3); and

(b)

the medicine or device is imported for the purposes of it being supplied to a particular patient; and

(c)

there is a complying special clinical needs supply authority for the patient for the medicine or device; and

(d)

the medicine or device is imported at the request of the person who issued the special clinical needs supply authority.

59 Pharmacists: wholesale supply (approved, approval-exempt, and unapproved products)

(1)

For the purposes of sections 51 and 53(1) and (2)(b), a pharmacist may supply a medicine or medical device by wholesale supply if—

(a)

the pharmacist complies with the licence requirements in section 57(3); and

(b)

the regulations permit the medicine or device to be supplied under this section; and

(c)

the pharmacist complies with any requirements specified in the regulations in relation to that supply.

(2)

For the purposes of sections 51 and 53(1) and (2)(a), a pharmacist may take a step in the manufacture of a medicine if—

(a)

the pharmacist is authorised under subsection (1) to supply the medicine by wholesale supply; and

(b)

taking the step is reasonably necessary to enable the pharmacist to supply the medicine; and

(c)

the regulations permit the pharmacist to take the step; and

(d)

the pharmacist complies with the licence requirements in section 57(3); and

(e)

the pharmacist complies with any requirements specified in the regulations in relation to taking the step.

60 Qualified pharmacy workers

(1)

For the purposes of sections 51 and 53, a pharmacy worker may carry on an activity that section 57, 58, or 59 authorises a pharmacist to carry on if the worker—

(a)

is qualified to carry on the activity; and

(b)

carries on the activity in a way that section 57, 58, or 59 authorises a pharmacist to carry on the activity; and

(c)

carries on the activity under the following level of supervision, or any lower level of supervision permitted by the rules,—

(i)

for the non-wholesale supply of a category 3 medicine, the general supervision of a pharmacist (pharmacist A); or

(ii)

for any other activity, the direct supervision of a pharmacist (pharmacist B).

(2)

However, if pharmacist A or B’s authority to carry on the activity is subject to any limitations, the pharmacy worker is subject to the same limitations.

(3)

To avoid doubt, section 57(2)(b)(ii) as applied by subsection (1)(b) of this section requires a determination of the appropriateness of the medicine for the patient to be made by a pharmacist, not by the pharmacy worker.

61 Health practitioners: approved and approval-exempt medicines
Non-wholesale supply of category 1 or 2 medicine

(1)

For the purposes of section 53(1) and (2)(c)(i) and (ii), a health practitioner may supply an approved or approval-exempt category 1 or 2 medicine by non-wholesale supply if—

(a)

they are a health practitioner prescriber for that medicine; and

(b)

the medicine is supplied—

(i)

to a patient of the practitioner; or

(ii)

for a patient of, and at the request of, another health practitioner prescriber for the medicine; and

(c)

the patient is in New Zealand or is ordinarily resident in New Zealand.

Non-wholesale supply of category 3 medicine

(2)

For the purposes of section 53(1) and (2)(c)(ii), a health practitioner may supply an approved or approval-exempt category 3 medicine by non-wholesale supply if—

(a)

the medicine is relevant to a health service that forms part of the practitioner’s scope of practice; and

(b)

the medicine is supplied—

(i)

to a patient of the practitioner; or

(ii)

for a patient of, and at the request of, another health practitioner; and

(c)

the patient is in New Zealand or is ordinarily resident in New Zealand.

Prescribing medicine

(3)

For the purposes of section 53(1) and (2)(d), a health practitioner may prescribe an approved or approval-exempt medicine if—

(a)

they are a health practitioner prescriber for that medicine; and

(b)

the medicine is prescribed—

(i)

for a patient of the practitioner; or

(ii)

for a patient of, and at the request of, another health practitioner prescriber for the medicine; and

(c)

the patient is in New Zealand or is ordinarily resident in New Zealand; and

(d)

any requirements for complying prescriptions specified in the regulations referred to in section 38(2) are complied with.

Administering category 1 medicine

(4)

For the purposes of section 53(1) and (2)(f), a health practitioner may administer an approved or approval-exempt category 1 medicine to another person if—

(a)

they are a health practitioner prescriber for that medicine; and

(b)

the medicine is administered—

(i)

to a patient of the practitioner; or

(ii)

to a patient of, and at the request of, another health practitioner prescriber for the medicine.

Dispensing

(5)

For the purposes of section 53(1) and (2)(a), a health practitioner may dispense an approved or approval-exempt medicine if—

(a)

they are a health practitioner prescriber for that medicine; and

(b)

the medicine is dispensed—

(i)

for a patient of the practitioner; or

(ii)

for a patient of, and at the request of, another health practitioner prescriber for the medicine; and

(c)

the patient is in New Zealand or is ordinarily resident in New Zealand.

Issuing standing order

(6)

For the purposes of section 53(1) and (2)(i), a health practitioner may issue a standing order for 1 or more approved or approval-exempt medicines if—

(a)

they are a health practitioner prescriber for every medicine to which the standing order applies; and

(b)

their scope of practice includes the issuing of standing orders for those medicines; and

(c)

every person authorised by the order is a person engaged in the delivery of health services (as defined in section 2 of the Health and Disability Commissioner Act 1994); and

(d)

everything that the standing order authorises a person to do is something that the practitioner could lawfully do; and

(e)

any requirements for standing orders specified in the regulations referred to in section 40(2) are complied with.

62 Health practitioners: unapproved products
Non-wholesale supply of category 1, 2, or 3 medicine, prescribing, administering, dispensing

(1)

For the purposes of sections 51 and 53, a health practitioner may carry on a controlled activity referred to in section 61(1) to (5) in relation to an unapproved medicine if—

(a)

they would be authorised by section 61 to do so if the medicine were an approved medicine; and

(b)

either—

(i)

there is a complying special clinical needs supply authority for the patient for that medicine; or

(ii)

the medicine,—

(A)

in the case of supplying, administering, or dispensing, was lawfully compounded for the patient; or

(B)

in the case of prescribing, will be compounded for the patient.

Non-wholesale supply of category 4 medicine

(2)

For the purposes of section 51, a health practitioner may supply an unapproved category 4 medicine by non-wholesale supply if—

(a)

the practitioner is a health practitioner prescriber for that medicine; and

(b)

the medicine is supplied—

(i)

to a patient of the practitioner; or

(ii)

for a patient of, and at the request of, another health practitioner prescriber for the medicine; and

(c)

the patient is in New Zealand or is ordinarily resident in New Zealand; and

(d)

either—

(i)

there is a complying special clinical needs supply authority for the patient for that medicine or device; or

(ii)

the medicine was lawfully compounded for the patient.

Non-wholesale supply of medical device

(3)

For the purposes of section 51, a health practitioner may supply an unapproved medical device by non-wholesale supply if—

(a)

the device is relevant to a health service that forms part of the practitioner’s scope of practice; and

(b)

the device is supplied—

(i)

to a patient of the practitioner; or

(ii)

for a patient of, and at the request of, another health practitioner whose scope of practice includes the same health service; and

(c)

the patient is in New Zealand or is ordinarily resident in New Zealand; and

(d)

there is a complying special clinical needs supply authority for the patient for that device.

63 Health practitioners: wholesale supply (approved, approval-exempt, and unapproved products)

For the purposes of sections 51 and 53(1) and (2)(b), a health practitioner may supply a medicine or medical device by wholesale supply if—

(a)

the regulations permit the medicine or device to be supplied under this section; and

(b)

for a medicine, the health practitioner supplying it and the person to whom it is supplied are both health practitioner prescribers for the medicine; and

(c)

for a medical device, it is supplied to a health practitioner; and

(d)

the health practitioner complies with any requirements specified in the regulations in relation to that supply.

64 Health practitioners: special clinical needs supply authority

(1)

For the purposes of section 53(1) and (2)(e), a health practitioner may issue a special clinical needs supply authority for an unapproved medicine or medical device for a person if—

(a)

the person is a patient of the practitioner; and

(b)

either—

(i)

for a medicine, the practitioner is a health practitioner prescriber for the unapproved medicine; or

(ii)

for a medical device, the device is relevant to a health service that forms part of the practitioner’s scope of practice; and

(c)

the regulations permit the special clinical needs supply authority to be issued; and

(d)

the practitioner is satisfied that the patient has a clinical need for a medicine or device; and

(e)

the practitioner is satisfied that—

(i)

no approved or approval-exempt product is available to meet that need; or

(ii)

if 1 or more approved or approval-exempt products are available to meet that need, there are special clinical reasons why none of them are suitable for the patient; and

(f)

any other criteria specified in the regulations are met.

(2)

For the purposes of section 51, a health practitioner who issues a complying special clinical needs supply authority for an unapproved medicine or medical device for a patient may import the medicine or device for the patient.

(3)

Regulations for the purposes of subsection (1)(c) may (without limitation) specify:

(a)

classes of health practitioners who may, or may not, issue a special clinical needs supply authority:

(b)

the circumstances in which health practitioners may, or may not, issue a special clinical needs supply authority:

(c)

the medicines or medical devices for which health practitioners may, or may not, issue a special clinical needs supply authority.

65 Health practitioner’s staff: non-wholesale supply of category 3 medicine

(1)

For the purposes of section 53(1) and (2)(c)(ii), a person who works for a health practitioner may supply an approved or approval-exempt category 3 medicine by non-wholesale supply if—

(a)

the health practitioner is authorised by section 61 to supply the medicine; and

(b)

the medicine is supplied to a patient of the health practitioner; and

(c)

the worker supplies the medicine under the general supervision of the health practitioner.

(2)

However, if the health practitioner’s authority to supply the medicine is subject to any limitations, the worker is subject to the same limitations.

66 Veterinarians: approved medicines
Non-wholesale supply of category 1, 2, or 3 medicine

(1)

For the purposes of section 53(1) and (2)(c)(i) and (ii), a veterinarian may supply an approved or approval-exempt category 1, 2, or 3 medicine by non-wholesale supply if—

(a)

the medicine is supplied—

(i)

to a patient of the veterinarian; or

(ii)

for a patient of, and at the request of, another veterinarian; and

(b)

the patient is in New Zealand or is ordinarily resident in New Zealand.

Prescribing medicine

(2)

For the purposes of section 53(1) and (2)(d), a veterinarian may prescribe an approved or approval-exempt medicine if—

(a)

the medicine is prescribed—

(i)

for a patient of the veterinarian; or

(ii)

for a patient of, and at the request of, another veterinarian; and

(b)

the patient is in New Zealand or is ordinarily resident in New Zealand; and

(c)

any requirements for complying prescriptions specified in the regulations referred to in section 38(2) are complied with.

Administering category 1 medicine

(3)

For the purposes of section 53(1) and (2)(f), a veterinarian may administer an approved or approval-exempt category 1 medicine to an animal if it is administered—

(a)

to a patient of the veterinarian; or

(b)

to a patient of, and at the request of, another veterinarian.

Dispensing

(4)

For the purposes of section 53(1) and (2)(a), a veterinarian may dispense an approved or approval-exempt medicine if—

(a)

it is dispensed—

(i)

for a patient of the veterinarian; or

(ii)

for a patient of, and at the request of, another veterinarian; and

(b)

the patient is in New Zealand or is ordinarily resident in New Zealand.

67 Veterinarians: unapproved products
Non-wholesale supply of category 1, 2, or 3 medicine, prescribing, administering, dispensing

(1)

For the purposes of sections 51 and 53, a veterinarian may carry on a controlled activity referred to in section 66 in relation to an unapproved medicine if—

(a)

they would be authorised by section 66 to do so if the medicine were an approved medicine; and

(b)

there is a complying special clinical needs supply authority for the patient for that medicine.

Non-wholesale supply of category 4 medicine or medical device

(2)

For the purposes of section 51, a veterinarian may supply an unapproved category 4 medicine or an unapproved medical device by non-wholesale supply if—

(a)

the medicine or device is supplied—

(i)

to a patient of the veterinarian; or

(ii)

for a patient of, and at the request of, another veterinarian; and

(b)

the patient is in New Zealand or is ordinarily resident in New Zealand; and

(c)

there is a complying special clinical needs supply authority for the patient for that medicine or device.

68 Veterinarians: wholesale supply (approved, approval-exempt, and unapproved products)

For the purposes of sections 51 and 53(1) and (2)(b), a veterinarian may supply a medicine or medical device by wholesale supply if—

(a)

the regulations permit the medicine or device to be supplied under this section; and

(b)

the medicine or device is supplied to another veterinarian; and

(c)

the veterinarian complies with any requirements specified in the regulations in relation to that supply.

69 Veterinarians: special clinical needs supply authority

(1)

For the purposes of section 53(1) and (2)(e), a veterinarian may issue a special clinical needs supply authority for an unapproved medicine or device for an animal if—

(a)

the animal is a patient of the veterinarian; and

(b)

the veterinarian is satisfied that—

(i)

the patient has a clinical need for medicine; and

(ii)

the use of the unapproved medicine or device to meet that need is clinically appropriate; and

(c)

the regulations permit the special clinical needs supply authority to be issued; and

(d)

any other criteria specified in the regulations are met.

(2)

For the purposes of section 51, a veterinarian who issues a complying special clinical needs supply authority for an unapproved medicine for a patient may import the medicine for the patient.

(3)

Regulations for the purposes of subsection (1)(c) may (without limitation) specify:

(a)

classes of veterinarian who may, or may not, issue a special clinical needs supply authority:

(b)

the circumstances in which veterinarians may, or may not, issue a special clinical needs supply authority:

(c)

the medicines or medical devices for which veterinarian may, or may not, issue a special clinical needs supply authority.

70 Veterinary staff

(1)

For the purposes of section 53, a person who works for a veterinarian may supply an approved or approval-exempt category 3 medicine by non-wholesale supply if—

(a)

the veterinarian is authorised by section 66 to supply the medicine; and

(b)

the medicine is supplied to a patient of the veterinarian; and

(c)

the worker supplies the medicine under the general supervision of the veterinarian.

(2)

For the purposes of section 53, a person who works for a veterinarian may carry on a controlled activity referred to in section 66 (other than the supply of a category 3 medicine by non-wholesale supply) if—

(a)

the veterinarian is authorised to carry on the activity; and

(b)

the worker carries on the activity in a way that section 66 authorises the veterinarian to carry on the activity; and

(c)

the worker carries on the activity at the request of, and under the direct supervision of, the veterinarian.

(3)

However, if the veterinarian’s authority to carry on the activity is subject to any limitations, the worker is subject to the same limitations.

71 Person authorised by standing order

For the purposes of sections 53(1) and (2)(c)(i) and (ii), and (f), and 54, a person may do any of the following if authorised to do so by a standing order:

(a)

supply an approved or approval-exempt category 1, 2, or 3 medicine by non-wholesale supply:

(b)

supply an approved or approval-exempt category 1 medicine without a complying prescription:

(c)

administer an approved or approval-exempt category 1 medicine.

72 Downstream supply or administration of medicine to patient

(1)

Subsection (2) applies if an approved or approval-exempt category 1, 2, or 3 medicine is lawfully supplied by non-wholesale supply in New Zealand to a person (person A) who is not the patient for whom the medicine is intended.

(2)

For the purposes of sections 53(1) and (2)(c)(i) and (ii), and (f), and 54, person A—

(a)

may—

(i)

supply the medicine to the patient; and

(ii)

if it is a category 1 medicine, do so without a complying prescription; or

(b)

may, if it is a category 1 medicine, administer it to the patient in accordance with the directions of the authorised prescriber who supplied or prescribed it.

(3)

If an unapproved medicine is lawfully supplied by non-wholesale supply in New Zealand to a person (person B) who is not the patient for whom the medicine is intended, for the purposes of sections 51 and 54, person B may—

(a)

supply the medicine to the patient; and

(b)

if it is a category 1 medicine, do so without a complying prescription.

73 Possession of category 1 medicine

For the purposes of section 53(1) and (2)(g)(i), a person may possess a category 1 medicine if—

(a)

the medicine was lawfully supplied to the person by non-wholesale supply; or

(b)

the person—

(i)

is authorised by a licence, permit, or provision of this Act to carry on a controlled activity in relation to the medicine; and

(ii)

has possession of the medicine incidental to carrying on that activity.

74 Possession of category 1 AMI

For the purposes of section 53(1) and (2)(g)(ii), a person may possess a category 1 AMI if—

(a)

the AMI was lawfully supplied to the person; or

(b)

the person—

(i)

is authorised by a licence, permit, or provision of this Act to carry on a controlled activity in relation to the AMI; and

(ii)

has possession of the AMI incidental to carrying on that activity.

75 Manufacture of custom-made devices

For the purposes of section 53(1) and (2)(a), a person may manufacture a medical device if—

(a)

they meet the criteria specified in the regulations for a person who may manufacture the device; and

(b)

the device is—

(i)

manufactured at the request of a health practitioner for a particular identified patient of that practitioner; and

(ii)

custom-made to meet the needs of that patient; and

(c)

the person complies with any requirements specified in the regulations.

76 Patient or carer importing medicine for personal use

(1)

For the purposes of section 51 or 52, an individual (person A) may do either of the following if they comply with the personal use import conditions:

(a)

import a medicine without it being approved; or

(b)

import an approved medicine without the sponsor’s consent.

(2)

However, this section does not apply to a medicine specified in the regulations as one to which this section does not apply.

(3)

The personal use import conditions are that—

(a)

person A acquired the medicine lawfully; and

(b)

the patient for whom the medicine is intended is—

(i)

person A; or

(ii)

another person or an animal for whom person A is a carer; and

(c)

in importing the medicine, person A is not acting in the course of a business; and

(d)

either—

(i)

the luggage conditions in subsection (4) are complied with; or

(ii)

the delivery conditions in subsection (5) are complied with.

(4)

The luggage conditions are that—

(a)

person A brings the medicine into New Zealand with them in their personal luggage; and

(b)

if person A is not the patient, the patient is travelling with person A; and

(c)

the amount of the medicine imported by person A at one time does not exceed—

(i)

if the medicine was prescribed by an authorised prescriber or an overseas health professional, the amount so prescribed; or

(ii)

otherwise, 3 months’ standard supply.

(5)

The delivery conditions are that—

(a)

the medicine is a category 2, 3, or 4 medicine; and

(b)

the amount of the medicine imported by person A at one time does not exceed 3 months’ standard supply; and

(c)

the amount of the medicine imported for the patient (regardless of who imports it or how it is imported) does not exceed 15 months’ standard supply in any 12-month period.

(6)

If a medicine obtained overseas is imported in reliance on this section, sections 72 and 73 apply as if—

(a)

the medicine had been supplied in New Zealand; and

(b)

section 72(2)(b) referred to the directions of the overseas health professional who supplied or prescribed the medicine (or if it wasn’t supplied or prescribed by a health professional, to the responsible manufacturer’s instructions).

(7)

A reference to a number of months’ standard supply of a medicine means the amount of the medicine that a notional average patient with the same condition would require for that number of months calculated on the basis of the recommended daily dose specified by the medicine’s responsible manufacturer.

77 Patient or carer importing medical device for personal use

(1)

For the purposes of section 51 or 52, an individual (person A) may do either of the following if they comply with the personal use import conditions:

(a)

import a medical device without it being approved; or

(b)

import an approved device without the sponsor’s consent.

(2)

However, this section does not apply to a medical device that is specified in the regulations as one to which this section does not apply.

(3)

The personal use import conditions for a device are that—

(a)

the device is imported for the purpose of its use on—

(i)

person A; or

(ii)

another person or an animal for whom person A is a carer; and

(b)

in importing the device, person A is not acting in the course of a business.

78 Authorisation for unapproved product stock in supply chain

(1)

This section applies if—

(a)

one of the following occurs:

(i)

a therapeutic product’s (product A) approval is cancelled (by the Regulator under section 109 or a court under section 236); or

(ii)

a therapeutic product’s (product A) approval lapses under section 104; or

(iii)

a major change is made to an approved product and the changed product (product A) is released into the supply chain without being approved (see section 100); and

(b)

a use of current stock notice is in force for product A.

(2)

For the purposes of sections 51 to 55, a person may carry on an activity referred to in any of those sections in relation to product A if—

(a)

the person would be authorised to carry on the activity in relation to product A if it were an approved product; and

(b)

the particular product in relation to which the person carries on the activity is current stock.

(3)

However, this section does not apply to the sponsor of product A (in their capacity as sponsor or in any other capacity).

(4)

If a person is authorised by this section to carry on an activity in relation to product A,—

(a)

the authorisation is subject to the same terms and conditions as the person’s authorisation referred to in subsection (2)(a); and

(b)

this Act applies to the person as if product A were an approved product.

(5)

A use of current stock notice is a Regulator’s notice identifying particular stock of a therapeutic product (current stock) as stock to which this section applies.

(6)

Stock identified in a use of current stock notice—

(a)

must exist at the time the notice is made; and

(b)

may be identified in any way the Regulator considers appropriate.

Example

Company M is the sponsor for product A and also imports and wholesales the product. Product A’s approval is cancelled but the Regulator issues a use of current stock notice for stock already in the supply chain. This allows health retailers, health practitioners, etc to continue to sell and use product A. But because Company M is the sponsor, it could not rely on this section to import or wholesale more stock.

There are other ways in which Company M could be authorised to import or wholesale more stock (such as a permit), or it could seek to get the product approved again.

79 Regulations may grant authorisations

(1)

For the purposes of sections 51 to 55, a person may do anything that would otherwise contravene those sections if they are authorised to do so by the regulations.

(2)

The regulations may authorise a person to do anything that would otherwise contravene any of sections 51 to 55.

80 Vending machines for medicine to be expressly authorised

A licence, permit, or provision of this Act that authorises a person to supply a medicine does not authorise supply by vending machine unless the licence, permit, or provision expressly states that it does.

Subpart 4—Other offences

Prohibited products

81 Prohibited products

(1)

A person must not import, manufacture, supply, administer or use on a patient, or be in possession of, a prohibited product unless authorised to do so by a permit.

(2)

The regulations may specify criteria for granting a permit relating to a prohibited product for the purposes of section 135(e).

(3)

If a person contravenes subsection (1),—

(a)

if they do so wilfully, they commit a level A1 offence; or

(b)

if they do so recklessly, they commit a level A2 offence; or

(c)

otherwise, they commit a level A3 offence.

(4)

A person who commits an offence under subsection (3) is liable on conviction to the appropriate penalty set out in section 233.

Advertising

82 Meaning of advertisement and related terms

(1)

An advertisement for a therapeutic product means a communication made to the public or a section of the public for the purpose of promoting the product.

(2)

A communication means a communication made in any way, whether made by an individual in person, using a physical object, or by means of any kind of audio, visual, electronic, or other method of communication.

(3)

However, the following are not advertisements for a therapeutic product:

(a)

any of the following made by the Regulator:

(i)

a statement made under section 161:

(ii)

a recall order:

(b)

a statement, approved by the chief executive of the Ministry, that is made as part of a public health campaign:

(c)

the pharmaceutical schedule (as defined in section 6(1) of the New Zealand Public Health and Disability Act 2000) published by the Pharmaceutical Management Agency (Pharmac) under that Act:

(d)

a communication that a person is required to make under this Act or any other law (provided that it complies with the law that requires it to be made):

(e)

a communication of a kind specified in the regulations.

(4)

To distribute, in relation to a communication, includes to make available, publish, display, circulate, broadcast, transmit, or otherwise bring to the notice of the public or a section of the public.

83 Advertising

(1)

A person must not distribute an advertisement for a therapeutic product unless,—

(a)

for a medicine, medical device, or type-4 product, the product is an approved product or an approval-exempt product; and

(b)

the advertisement complies with the advertisement requirements in subsection (2); and

(c)

the distribution complies with any distribution requirements specified in the regulations.

(2)

The advertisement requirements are that an advertisement—

(a)

must contain—

(i)

the name of the person who is promoting the product using the advertisement; and

(ii)

any other information specified in the regulations; and

(b)

must not contain,—

(i)

if it is an approved product, information that is, directly or by implication, inconsistent with its approval; or

(ii)

any misleading information; and

(c)

must comply with any requirements specified in the regulations.

(3)

Regulations specifying advertisement or distribution requirements may (without limitation) relate to any of the following:

(a)

the content of an advertisement:

(b)

the form of an advertisement:

(c)

how an advertisement is distributed:

(d)

to whom an advertisement is distributed.

(4)

If a person contravenes subsection (1) in circumstances that are not infringement circumstances,—

(a)

if they do so wilfully, they commit a level A1 offence; or

(b)

if they do so recklessly, they commit a level A2 offence; or

(c)

otherwise, they commit a level A3 offence.

(5)

A person who commits an offence under subsection (4) is liable on conviction to the appropriate penalty set out in section 233.

(6)

A person who contravenes subsection (1) in infringement circumstances commits an infringement offence and is liable to an infringement fee or a fine as set out in section 251.

Tampering

84 Meaning of tamper with and create a risk of harm

(1)

To tamper with a therapeutic product means—

(a)

to interfere with—

(i)

the product itself; or

(ii)

the product’s manufacturing process; or

(iii)

the product’s performance; or

(iv)

the product’s packaging or labelling; or

(v)

the product’s product or consumer information; and

(b)

to do so in a way that adversely affects the product’s quality, safety, or efficacy or performance, or might reasonably be expected to do so.

(2)

Tampering with a therapeutic product creates a risk of harm if the tampering—

(a)

directly or indirectly—

(i)

causes harm; or

(ii)

significantly increases harm; or

(iii)

creates a significant risk of harm; or

(iv)

significantly increases a risk of harm; or

(b)

might reasonably be expected to do something referred to in paragraph (a).

85 Tampering with therapeutic products

(1)

A person must not—

(a)

tamper with a therapeutic product in a way that creates a risk of harm; or

(b)

threaten to do so; or

(c)

claim to have done so.