Archive
20 Sep Over-arching: Good Review Practice Guide
Posted at 10:10h
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This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...
08 Sep Extension on commentary period for Borderline Products Guideline
Posted at 09:23h
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Please note that the South African Health Products Regulatory has hereby extended the deadline date for comments on the Borderline Products guideline (SAHPGL-CRO-01) from the 5th of September 2022, to the 8th of November 2022....
29 Aug Missing Applications – Call to Industry
Posted at 08:49h
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Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....
12 Aug SAHPRA Digital Transformation – Deployment of a Stakeholder portal
Posted at 17:24h
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In keeping with SAHPRA’s strategic objectives – Digital Transformation has been a key focus are for SAHPRA ICT....
02 Aug Regulations Regarding Fees Payable In Terms Of The Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965)
Posted at 15:35h
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The Minister Of Health, In Consultation With The Minister Of Finance And SAHPRA, In Terms Of Section 35 (1) (Xxi) And (Xxxii) Read Together With Section 35(4) Of The Medicines And Related Substances, Made Regulations In The Schedule....
02 Aug Exclusion Of Medicines, Medical Devices And (IVDs) Donated To The State
Posted at 15:30h
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Exclusion Of Medicines, Medical Devices And In Vitro Diagnostics 22 May 2020 (IVD's) Donated To The State From The Operation Of Certain Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965)...
02 Aug General Regulations – Medicines And Related Substances Act, 1965 (25 August 2017)
Posted at 15:26h
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The Minister of Health, in consultation with the Authority, has in terms of section 35 of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), made the Regulations in the Schedule....