Complementary Medicines & Health Supplements
On 15 November 2013, amendments to the General Regulations pertaining to the Medicines Act were published, which defined Complementary Medicines and specified requirements for registration, compliance to the South African Packaging: Labels, Package Inserts and Patient Information Leaflets.
As of 25 August 2017 the General Regulations to the Medicines Act have been amended, GG. No. 41064, Notice No. 859. These include Health Supplements as a subcategory of Complementary Medicines – Category D Medicines.
Licensing guidance was issued to inform companies to include their product lists in new license applications or submit them retrospectively. Licensing became a mandatory requirement and a condition of continuing with the sale of CMs as of 15 November of 2013.
The MCC has issued several guidance documents related to the regulation of CMs, GxP compliance and registration requirements. We can support with the following:
- Advising on compliance matters
- Labelling requirements
- Data Due Diligence
- Dossier compilation
- Regulatory authoring for data not available in CTD format
- GxP implementation, including support with:
- Master documents
- Site Master Files
- Quality Manuals