Archive

02 Jun Communication to industry – SAHPRA Statement on Regulation of Category D Medicines

Posted at 15:22h in

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...

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07 Mar Communication to industry – 7.04 Health Supplements Safety and Efficacy

Posted at 16:39h in

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...

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03 Mar Requests: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021)

Posted at 11:01h in

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...

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01 Feb Validation template CM

Posted at 10:32h in

This document has been archived....

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27 Jan Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters

Posted at 22:42h in

2020 Feb...

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27 Jan REQUESTS: Existing Category D (Complementary Medicines) Registration Applications – COMPLEMENTARY MEDICINES APPLICATIONS SUBMITTED FOR REGISTRATION

Posted at 22:41h in

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...

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27 Jan Review of detained product at a port of entry as a Category D medicine

Posted at 22:39h in

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...

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27 Jan Application for a certificate of free sale for Category D medicines (Complementary Medicines)

Posted at 22:37h in

Medicines Act” means the Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended. ...

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

Posted at 09:45h in

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...

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25 Jan CMs Specified Substances

Posted at 12:22h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of...

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