Veterinary medicines Archives

29 Sep Format for Dear Veterinary Professional Letter Template

Posted at 12:28h in

This document is intended to provide communication to industry and guide stakeholders on how to prepare and distribute “Dear Veterinary Professional” (DVP) letters for safety concerns associated with the use of registered veterinary medicines. It gives details on the format and content to effectively communicate...

12 Aug General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965: Amendment to Regulation 6: Notice of Correction

Posted at 11:43h in

The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...

10 Jun Application Letter Template: Post-registration Variations

Posted at 11:23h in

New cover letter template for post-reg variations...

30 Mar SAHPRA Advisory on the Use of Unregistered Veterinary Products

Posted at 14:43h in

This document is intended to provide communication to all veterinarians and Veterinary Institutions in the Republic of South Africa to reinforce the importance of compliance with national legislation regarding the use of unregistered veterinary medicines. As stewards of animal health and welfare in South Africa,...

18 Nov Core Business Escalation Procedure

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

10 Jun Communication to Industry – SAHPRA Updates Regarding the Use of Yohimbine in Veterinary Medicine

Posted at 16:05h in

This communication to industry was developed to express SAHPRA’s view that the therapeutic use of yohimbine in animals may be in the public interest and to outline the steps that SAHPRA is taking to place the product in the schedules....

11 Oct Communication to Industry – Request for Scientific Information on Yohimbine Use in Veterinary Medicine

Posted at 11:08h in

This communication is intended to seek stakeholder input in gathering scientific information regarding the use of yohimbine in veterinary medicine....

22 Mar Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 1965

Posted at 13:47h in

This document provides guidance on access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Applicants are required to comply with the provisions of the Act and Regulations....

22 Mar Section 21 Emergency Medicines Bulk Application Form

Posted at 13:43h in

Request For Use of An Unregistered Product In Terms of Section 21 of Act 101 of 1965...

28 Aug Veterinary Medicines Registration form

Posted at 10:01h in

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