South Africa is among the advanced nations in the African continent and offers good demand for import of health supplements. These products are governed by the South African Health Products Regulatory Authority (SAHPRA) in the country. The Self-medication Manufacturers Association of South Africa (SMASA) represents and supports companies involved in the manufacturing, sales, distribution, and consultation of healthcare products (including Over the Counter [OTC] and complementary medicines). The Department of Agriculture, Forestry, and Fisheries (DAFF) regulates safety and quality of agriculture and animal products. The National Department of Health requires that all foodstuffs should be safe for human consumption in terms of the Foodstuffs, Cosmetics and Disinfectant Act, 1972 (FCD Act). This Act addresses the manufacture, labeling, sales, and importation of foodstuffs.
As per the requirement of South African Health Products Regulatory Authority (SAHPRA), Freyr can carry out technical evaluation of the products and provides assistance in classifying whether a product falls under food category or in health supplements category and also support publishing and submission of registration applications in the latest version of the Common Technical Document (ZA-CTD) format.
- End-to-end Regulatory Consultation and Registration Support
- Regulatory Strategy and Pathways
- Food Product Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Compilation and Submission of Dossier to the Health Authority (SAHPRA)
- Legal Representation Services
- Regulatory Intelligence Report
- GMP Audit Support
- Product-specific Updates on Regulatory Guidelines/Standards
- Import Guidance
- ZA-CTD Dossier Compilation
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
Support for region-specific Regulatory activities
Extensive partner network across the globe
A strong relationship with various Health Authorities