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Health Products (Therapeutic Products) Regulations 2016

Status:

Current version
as at 16 Apr 2024

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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 patent 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)

FIRST SCHEDULE Psychotropic substances

SECOND SCHEDULE

THIRD SCHEDULE

FOURTH SCHEDULE

FIFTH SCHEDULE Cautionary information to be labelled on therapeutic products

SIXTH SCHEDULE Repealed

SEVENTH SCHEDULE

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Table Of Contents

Health Products (Therapeutic Products) Regulations 2016

Status:

Current version
as at 16 Apr 2024

Please check the legislation timeline to ensure that you are viewing the correct legislation version. See also FAQ B3.

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Timeline

Document
Provision

Versions

or

find current version as at

18 Dec 2023

Amended by
S 811/2023
01 Nov 2023

Amended by
S 681/2023
26 Jun 2023

Amended by
S 436/2023
01 Jul 2022

Amended by
S 458/2022
03 Jan 2022

Amended by
S 1081/2021
31 Dec 2021

Amended by
S 436/2023
01 Oct 2021

Amended by
S 732/2021
01 Dec 2020

Amended by
S 969/2020
02 Apr 2019

Amended by
S 92/2019
01 Mar 2018

Amended by
S 119/2018
01 May 2017

Amended by
S 219/2017
01 Nov 2016

SL 329/2016

Table of Contents

Health Products (Therapeutic Products) Regulations 2016
Enacting Formula Part 1 PRELIMINARY

1 Citation and commencement

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 patent 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

FIRST SCHEDULE Psychotropic substances SECOND SCHEDULE THIRD SCHEDULE FOURTH SCHEDULE FIFTH SCHEDULE Cautionary information to be labelled on therapeutic products SIXTH SCHEDULE Repealed SEVENTH SCHEDULE

Health Products (Therapeutic Products) Regulations 2016

Status:

Current version as at 16 Apr 2024

Timeline
Authorising Act
Amendment Annotation

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Actions
- Add to My Collections
- Amendments RSS Feed

Document
Provision

01 Nov 2016

SL 329/2016
01 May 2017

Amended by
S 219/2017
01 Mar 2018

Amended by
S 119/2018
02 Apr 2019

Amended by
S 92/2019
01 Dec 2020

Amended by
S 969/2020
01 Oct 2021

Amended by
S 732/2021
31 Dec 2021

Amended by
S 436/2023
03 Jan 2022

Amended by
S 1081/2021
01 Jul 2022

Amended by
S 458/2022
26 Jun 2023

Amended by
S 436/2023
01 Nov 2023

Amended by
S 681/2023
18 Dec 2023

Amended by
S 811/2023

Versions

or find current version as at

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In exercise of the powers conferred by sections 71 and 72 of the Health Products Act, the Health Sciences Authority, with the approval of the Minister for Health, makes the following Regulations:

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Last updated 16 Apr 2024
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