The Health Regulation 1996 Part 16 - Therapeutic Goods and other Drugs aims to establish standards for goods of a therapeutic nature and to allow for sampling and testing of these goods. Sampling and testing is conducted to ensure that goods comply with standards, safety in packaging and truth in labelling and advertising.
Scope of this legislative Instrument
Part 16 of the Health Regulation 1996 prescribes controls for therapeutic goods and other drugs, as defined, in the areas of:
- good manufacturing practice
- distribution and storage
- packaging and labelling
- batch coding and expiry dating
- cautionary and warning statements
- product claims
- instructions and dosage
- prohibited claims
- product standards.
The Health Regulation 1996 also further prescribes the requirements on specifications for premises where therapeutic goods are packed or manufactured.