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
Guidance and resources
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PageFinished product (medicine) analytical procedure validations for complementary medicines.
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Reference materialTest procedures for starting materials used in complementary medicines must use analytical methods that are validated for that purpose.
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Reference materialdescribes the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines
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FormsInformation on completing and submitting an OTC analytical validation summary form
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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GuidanceGuidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.
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GuidanceThis guidance describes the safety and efficacy data you will need for CTD Module 4 and Module 5 to support applications to either register an OTC medicine in the ARTG or vary the safety and/or efficacy aspects of a registered OTC medicine. (Formerly ARGOM Appendix 1)