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You must certify that you hold the relevant documentation to substantiate the safety, quality and efficacy of your product for the purposes for which they are to be used.
Some non-prescription medicines comprise relatively simple ingredients (for example: amino acids, mineral salts, vitamins) and the quality parameters applying to such products are essentially the same as for other medicines.
Special considerations are required for those listed medicines that contain complex ingredients, that are difficult to characterise, and/or certain combinations of multiple active ingredients.
See:
- Quality for listed medicines
- International scientific guidelines adopted in Australia
- Ongoing stability testing for listed and complementary medicines
Guidance on test methods for therapeutic sunscreens
- Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches
- OECD Test guidelines for the Chemicals
- The European Commission's Tracking System for Alternative methods towards Regulatory acceptance (TSAR)
- The European Commission's science and knowledge service
- www.cir-safety.org
- The Scientific Committee on Consumer Safety (SCCS) notes of guidance for the testing of cosmetic ingredients and their safety evaluation 10th revision