Health Products (Therapeutic Products) Regulations 2016
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
3 Scope of Regulations
Part 2 MANUFACTURE AND IMPORT OF THERAPEUTIC PRODUCTS
Division 1 — Manufacture
4 Requirements for issue of manufacturer’s licence
Division 2 — Import
5 Requirements for issue of importer’s licence
6 Import of therapeutic products containing psychotropic substances
Part 3 SUPPLY OF THERAPEUTIC PRODUCTS
7 Requirements for purposes of section 17
Division 1 — Requirements for wholesale supply of therapeutic products
8 Export of therapeutic products containing psychotropic substances
9 Export of codeine cough preparations
10 Wholesale of therapeutic products containing Second Schedule ingredients
Division 2 — Requirements for retail supply of registered therapeutic products
11 Supply by retail sale of prescription-only medicine
12 Supply by administration of prescription-only medicine
13 Supply by retail sale of pharmacy-only medicine
14 Restrictions on supply by retail sale of codeine cough preparations
15 Supply of general sale list medicine by retail sale vending machine
Division 3 — Other requirements for supply of therapeutic products
16 Records of supply of prescribed therapeutic products
17 Supply by dispensing therapeutic products
Division 4 — Requirements for wholesaler’s licence
18 Requirements for issue of wholesaler’s licence
Part 4 PRESENTATION OF THERAPEUTIC PRODUCTS
19 Trade descriptions
20 Information to be provided with therapeutic products
21 Corrective measures in relation to contravening trade descriptions or failure to provide prescribed information
Part 5 REGISTRATION OF THERAPEUTIC PRODUCTS
22 Requirements for registration
23 Whether therapeutic product subject to patent
24 Cancellation of registration of therapeutic product subject to patent dispute
24A Prescribed time for cancellation of registration of therapeutic product for non‑payment of retention fee
25 Offences for making false declaration
26 Protection of confidential supporting information relating to innovative therapeutic product applications
27 Circumstances where protection under regulation 26 does not apply
28 Disclosure of information on applications for registration
29 Registration exclusivity
Part 6 DUTIES AND OBLIGATIONS OF MANUFACTURERS, IMPORTERS, ETC., OF THERAPEUTIC PRODUCTS
Division 1 — General duties
30 Duty to comply with enforcement requirements
31 Duty to maintain records of manufacture
32 Duty to maintain records of receipt and supply
33 Duty to maintain records of defects and adverse effects
34 Duty to report defects and adverse effects
35 Duty to notify Authority concerning recall
Division 2 — Duties specific to licensees
36 Duty of licensed manufacturer
37 Duty of licensed importer
38 Duty of licensed wholesaler
39 Responsible person
40 Offence for contravention of duties
41 Changes affecting licence
Division 3 — Duties specific to registrants
42 Changes concerning registered therapeutic product
43 Information on validity of data submitted to or considered by Authority
44 Submission of benefit-risk evaluation reports
45 Duty to carry out risk management plan
Part 7 EXCEPTIONS — MANUFACTURE, IMPORT AND WHOLESALE OF THERAPEUTIC PRODUCTS WITHOUT LICENCE
Division 1 — Specified healthcare service licensees
46 Compounding of therapeutic products at approved permanent premises, etc., of specified healthcare service licensees without manufacturer’s licence
47 Transfer of therapeutic products by specified healthcare service licensees without wholesaler’s licence
Division 2 — Licensed retail pharmacies
48 Compounding of therapeutic products at licensed retail pharmacies without manufacturer’s licence
49 Wholesale supply by holders of pharmacy licences without wholesaler’s licence
Division 3 — Named patients
50 Re-labelling of therapeutic products without manufacturer’s licence
51 Import of therapeutic products for patients’ use without importer’s licence
Division 4 — Personal imports
52 Import of therapeutic products for personal use without importer’s licence
Division 5 — Wholesale of therapeutic products for export
53 Wholesale of therapeutic products imported solely for export without wholesaler’s licence
Division 6 — Other exceptions
54 Import of health products by licensed manufacturer without importer’s licence
55 Wholesale of self-manufactured therapeutic products without wholesaler’s licence
56 Wholesale of therapeutic products to ships or aircraft without wholesaler’s licence
57 Therapeutic products for research or non‑clinical purposes
Part 8 EXCEPTIONS — SUPPLY OF THERAPEUTIC PRODUCTS WITHOUT REGISTRATION
58 Prescribed exceptions
59 Supply of therapeutic products compounded under contractual agreement with licensed manufacturer
60 Previously registered therapeutic products
Part 8A EXCEPTION — EMERGENCY THERAPEUTIC PRODUCTS
60A Manufacture, import and supply of emergency therapeutic product
Part 9 MISCELLANEOUS
61 Certification of therapeutic products intended for export
62 Certificate of manufacturing standard of therapeutic products
63 Certificate of distribution standard of therapeutic products
64 Other certificates or documents
65 Product quality surveillances
66 Non-compliant therapeutic products
67 Confidential information
68 (Deleted)