TNHA COMMENTS ON SAHPRA ROADMAP AND TRANSITIONAL PROCESS FOR THE REGULATION OF CATEGORY D MEDICINES (16 July 2023)

SUMMARY

The Traditional and Natural Health Alliance (TNHA) commented on SAHPRA’s 16 July Roadmap for regulating Category D medicines, arguing it is invalid and unlawful. They state that regulations should not introduce issues not covered by the primary statute, which the current guideline does by addressing complementary medicines not defined in the Medicines Act. Previous court rulings declared such regulations invalid, and TNHA criticizes SAHPRA for not complying with these rulings and for acting beyond its powers. TNHA calls for a separate regulatory framework for complementary medicines, distinct from the Medicines Act, to ensure proper governance and representation for the industry. They emphasize the need for a new statute specifically for traditional and natural health products, rather than attempting to amend existing pharmaceutical regulations, which has repeatedly failed.

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