Following interaction with various stakeholders, the category of Complementary Medicines was broadened by SAHPRA to establish two sub-categories of Category D (Complementary) medicines, reflected in the General Regulations published and implemented as per Government Notice 859 in Government Gazette 41064 on 25 August 2017. This resulted in the inclusion of new sub-categories of Category D, including those traditional disciplines that are not indigenous to South Africa (discipline-specific medicines) but also the more modern supplement-type of medicines (health supplements).
Health supplements allow only LOW RISK indications and substances, in accordance with lists of substances, dosage ranges and indications stipulated in the guidelines issued by SAHPRA. The objective of this workshop is to take an in depth look at Health supplements.
- Understand the general structure of the CTD as it relates to CM’s.
- Understand the Licensing requirements for CM’s
- An in depth look at the guidelines that are relevant to CMs as required by SAHPRA
- The Quality section of the CTD with emphasis on the 3.2.S module requirements for Health supplements.
- Claims and supportive data required specifically for Health Supplements.