updated – Roadmap and transitional process for the Regulation of complementary medicines

The amended Guideline 7.02 (Roadmap and Transitional Process for the regulation of Complementary medicines) with transitional arrangements was developed and published on the SAHPRA website by early August 2019. The guideline established the roadmap and general overview for the regulatory pathway of complementary medicines including licensing in terms of section 22C(1)(b) and submission of applications for their registration following the implementation of the General Regulations in 2017 and applies to products for human use (discipline-specific medicines and health supplements).

2021 Dec