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.
- Finished product (medicine) analytical procedure validations for complementary medicines
- Starting material analytical procedure validation for complementary medicines
- Analytical procedure validation for complementary medicines
- Compositional guidelines
- Literature-based submissions for listed medicines and registered complementary medicines
- OTC analytical validation summary form
- Assurances to accompany an OTC new medicine N2 application
- ARGOM Appendix 2: Guidelines on quality aspects of OTC applications
- ARGOM Appendix 4: Guidelines on OTC applications for new substances
- Assurances to accompany an OTC new medicine N1 application
- OTC medicines - Safety and efficacy data