Archive
13 Jun Communication on Medicines Registration Renewals Implementation Framework
Posted at 18:43h
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This document sets out the proposed approach that SAHPRA undertakes to implement the process of medicine registration renewals ensuring a consistent approach to benefit all stakeholders to ensure quality, efficacious and safe products are available to the public....
13 Jun Retention Fee Notification – 9 June 2022
Posted at 16:03h
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Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...
27 May Application Form for Lot Release of Human Vaccine
Posted at 16:15h
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The application form shall be used for an application for lot release of a human vaccine submitted to the South African Health Products Regulatory Authority....
27 May Guideline for Lot Release of Human Vaccines
Posted at 16:11h
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Version 3
This document is intended to provide guidance to applicants for lot release requirements for all human vaccines. This will be a “living document” and will be updated on a regular basis. It is important that applicants adhere to the prescribed requirements in order to...
14 Apr General guidance document on QSE for Biological Medicines
Posted at 10:18h
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This guideline is intended to provide guidance to applicants wishing to submit new application for registration of biological medicines. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right...
30 Mar Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines
Posted at 09:35h
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As of the 1st of April 2022, the post-importation testing exemption requests for Biological and Biosimilar medicines should be submitted as per the requirements of Guideline 2.04. For submission process, please refer to section 3.0 Post-Importation Testing Exemptions (PITE)....
24 Jan Biological Medicines Amendment guideline
Posted at 12:51h
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This guideline is intended to provide recommendations to applicants wishing to submit amendments for registered BIOLOGICAL medicines. It represents SAHPRA’s current thinking on ensuring the safety, quality and therapeutic efficacy of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right to...
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