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This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specific substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific...

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a...