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27 Apr

Posted at 12:44h in

Company name & Address   registration number   Batch number   Expiry date   Pack size   First distributed   Re-call Classification   Re-call Date   Adcock Ingram limited – 1 New road, Midrand 1685, South Africa   B/2.8/858   AC1696   Sept-2022   24   11/2020   Class II Type B 13 July 2021   Reason for recall The product was being recalled due to quality defect: Discoloration of tablets found in the batch.   Advice to HCPs/Distributors/Public: The identified batches blocked...

16 Apr

Posted at 16:10h in

The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants that Type II Variations Pilot submission window has been extended from 21 April 2026 to 30 April 2026....

01 Apr

Posted at 14:01h in

The South African Health Products Regulatory Authority (SAHPRA) launched the Online Medicines Directory for over-the-counter (OTC) medicines in June 2022. The platform, available at www.medsinfo.sahpra.org.za, serves as a single, trusted source of information for patients, consumers, and healthcare professionals on all medicines approved by SAHPRA. Phase...

26 Mar

Posted at 08:28h in

The Medicines and Related Substances Act No. 101 of 1965 as amended makes provisions for the payment of retention fees to the South African Health Products Regulatory Authority (SAHPRA) in respect of medicines registered, medical devices, including in vitro diagnostics (IVDs), establishment licences issued. These...

26 Feb

Posted at 10:35h in

SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the SADC Region to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the ZAZIBONA Centralised Procedure....

13 Feb

Posted at 12:45h in

The screening checklist is used to verify that all required information has been provided to SAHPRA to evaluate an application for the new registration of a medicinal product for human use. The applicant must ensure that all relevant fields are completed and hyperlinked. For a...

06 Feb

Posted at 09:13h in

SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the African continent to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the African Medicines Agency (AMA)...