Health Products (Oral Dental Gums) Regulations 2016
Table of Contents
Enacting Formula
Part 1 Preliminary
1 Citation and commencement
2 Definitions
Part 2 Supply of oral dental gums
3 Supply by retail sale of oral dental gums
4 Records of supply by retail sale of oral dental gums
Part 3 Presentation of oral dental gums
5 Display of information on oral dental gums
6 List of ingredients
7 Manner in which particulars are to be stated
Part 4 Advertisement of oral dental gums
8 Prohibition against advertisement of prescription‑only oral dental gum
9 No advertisement of oral dental gums except with prior approval of Authority
10 Application for variation of approved advertisement
10A Application for transfer of approval of an advertisement
11 Exception for trade, business or profession
12 Exception for trade advertisement
13 Sales promotions
Part 5 Matters relating to licences and registration
14 Requirements for issue of importer’s licence
15 Requirement for registration of oral dental gums
15A Prescribed time for cancellation of registration of oral dental gum for non‑payment of retention fee
Part 6 Duties of manufacturers, importers, etc., of oral dental gums
Division 1 — General duties
16 Duty to comply with enforcement requirements
17 Duty to maintain records of defects and adverse effects
18 Duty to report defects and adverse effects
19 Duty to notify Authority concerning recall
Division 2 — Duties specific to licensees
20 Duty of holder of manufacturer’s licence
21 Duty of holder of importer’s licence
22 Duty of holder of wholesaler’s licence
23 Offence for contravention of duties
24 Changes affecting licence
Division 3 — Duties specific to registrants
25 Changes concerning registered oral dental gum
26 Submission of samples for testing
27 Information on validity of data submitted to or considered by Authority
Part 7 (Deleted)