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.
Since November 2013, various amendments to the definition of Complementary Medicines have been published for comment and Category D as of September 2014 contains Health Supplements as a subcategory. The final stages of comment on the amended General Regulations closed on 26 April 2017 and promulgation of the finalised legislation is awaited.
The Call-up Notice of 22.02.2002 was repealed on 24.02.2017 (GG. No. 40637 Notice No. 157).
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 are au fait with the scientific and administrative requirements and 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