This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
In response to the Supreme Court of Appeal (SCA) judgment on 11 April 2022 regarding the Alliance of Natural Health Products (ANHP), the Minister of Health recently released, for public comment, draft amendments to the General Regulations made in terms of the Medicines and Related...
The purpose of Guideline 7.04 (Complementary Medicines - Health Supplements Safety and Efficacy) is to provide clear guidance with regard to the safety and efficacy (SE) requirements for registration of Health Supplements as a subset of complementary medicines in South Africa in the Common Technical...
The corresponding stakeholder notice dated 07 October 2021 regarding the opportunity to update online the application details and/or the submission before review refers.
A further opportunity to resubmit an existing application on the CM portal is made in Phase 2 which is foreseen to extend to...
2020 Feb...
Category D Medicines (Complementary Medicines) has been established in the General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Medicines compliant with the prescribed definition for this category are included in Guidance on progression to regulatory compliance...
Customs and Port Health Service (PHS) in SA, is the first line of defence to protect the citizens of the Republic of South Africa against the health risks associated with cross-border movement of people, conveyances, baggage, cargo and imported consignments. Among the imported consignments are...
Medicines Act” means the Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended. ...
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...