We assist our clients to comply with the current requirements for their individual needs. Our clients have come to rely on our expert advice and prompt service.
On 15 November 2013 and on 25 August 2017, amendments to the General Regulations pertaining to the Medicines Act were published, which defined Complementary Medicines and specified requirements for the South African Packaging: Labels, Package Inserts and Patient Information Leaflets.
The compliance requirements for licensing of facilities importing, exporting, manufacturing and selling Complementary Medicine products and Health Supplements were recently reiterated by the SAHPRA in their Roadmap and Labelling Annexure [https://www.sahpra.org.za/].
We can assist with the following:
- Product Classification
- Labelling requirements
- Data Due Diligence
- Dossier compilation
- Regulatory authoring for data not available in CTD format
- eCTD publishing
- Licensing of Facilities
- Quality Management System development & implementation
- Vigilance expectations