South Africa is among the most advanced nations in the African continent and offers a good demand for the import of health supplements. The products are governed by the South African Health Products Regulatory Authority (SAHPRA). 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 the safety and quality of agricultural and animal products. The National Department of Health requires all foodstuffs to be safe for human consumption as per the Foodstuffs, Cosmetics, and Disinfectant (FCD) Act, 1972. The act addresses the manufacture, labeling, sales, and importation of foodstuffs.
Based on the requirement of the SAHPRA, Freyr can carry out technical evaluation of the products, assist in classifying whether a product falls under the “Food” category or the “Health Supplements” category, and support in 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 Pathway Report
- GMP Audit Support
- Product-specific Updates on Regulatory Guidelines/Standards
- Import Guidance
- ZA CTD Dossier Gap Analysis and Compilation
A 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 in region-specific Regulatory activities
An extensive partnership network across the globe
A strong relationship with various Health Authorities (HAs).