Health Products (Active Ingredients) Regulations 2023
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
3 Application
Part 2 PROHIBITION AGAINST DEALING WITH ADULTERATED, COUNTERFEIT, ETC., ACTIVE INGREDIENTS
4 Prohibition against manufacture of adulterated, counterfeit or unwholesome active ingredients
5 Prohibition against import or supply of adulterated, counterfeit, etc., active ingredients
Part 3 LICENCES
Division 1 Where licences required
6 Licence required for manufacture of active ingredients
7 Licence required for import of active ingredients
8 Licence required for wholesale of active ingredients
9 Persons who do not require manufacturer’s licences
10 Persons who do not require importer’s licences
11 Persons who do not require wholesaler’s licences
Division 2 Requirements for issue of licence
12 Requirements for issue of manufacturer’s licence
13 Requirements for issue of importer’s licence
14 Requirements for issue of wholesaler’s licence
Part 4 DUTIES OF PERSONS DEALING WITH ACTIVE INGREDIENTS
Division 1 General duties in relation to storage and transport
15 Storage of active ingredients
16 Transport of active ingredients
Division 2 General duties in relation to import, export and supply
17 Import of active ingredients that are psychotropic substances
18 Export of active ingredients that are psychotropic substances
19 No retail supply of active ingredients
20 Information that must accompany supply of active ingredient
21 Wholesale of active ingredients
Division 3 Duties to maintain records and notify of recall
22 Duty to maintain records of manufacture
23 Duty to maintain records of receipt and supply
24 Duty to maintain records of defects
25 Duty to notify Authority concerning recall
Division 4 Duties specific to licensees
26 Duty of licensed manufacturer
27 Duty of licensed importer
28 Duty of licensed wholesaler
29 Responsible person
30 Changes affecting licences
Part 5 CERTIFICATES
31 Application of this Part
32 Certification of active ingredients intended for export
33 Certificate of manufacturing standard of active ingredients
34 Certificate of distribution standard of active ingredients
Part 6 MISCELLANEOUS
35 Enforcement officers may conduct routine inspections
36 Form and manner of applications and notices
37 Saving and transitional provisions