New cover letter template for post-reg variations...
This guideline is intended to provide guidance to applicants who intend to submit extension applications for registration. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current position on the safety, quality and efficacy of these medicines. ...
Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Ranbaxy Pharmaceuticals (Pty) Ltd 14 Lautre Road, Stormill Extension 1 Roodepoort Johannesburg 1724 32/20.1.1/0214 DFG4606A 30 June 2027 100ml 06 November 2025 Class II Type B 20 May 2026 Brief description of the problem (reason for recall) The recall is initiated because of an Out of...
Reporting side effects Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products....
Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Asante Pharma 15 Cleeve Road Henley on klip Gauteng N/A B250515 B260383 B260382 B250514 February 2027 October 2027 October 2027 February 2027 200ml 06 October 2025 Class III Type C 14 May 2026 Brief description of the problem (reason for recall) This recall is initiated due to the contravention of Section 14...
Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Pharmacare Limited trading as Aspen Pharmacare Healthcare Park, Woodlands Drive, Woodmead, 2196 41/21.5.1/0189 E0023605 June 2027 50ml 15 October 2025 Class II Type B 08 May 2026 Brief description of the problem (reason for recall) This recall is initiated because incorrect labelling has been...
This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all Applicants/ Holders of Certificates of Registration (HCRs) who intend to submit/ have submitted applications supported by bioequivalence studies conducted by Raptim Research Pvt. Ltd, a Contract Research Organisation...
Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Dr Reddy’s Laboratories (Pty) Ltd Block C, Woodmead North Office Park, 54 Maxwell Drive, Woodmead, Sandton 56/8.2/0106 T2504569 August 2027 60’s 21 January 2026 Class II Type B 04 May 2026 Brief description of the problem (reason for recall) This recall is initiated due...
Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Eisai Pharmaceuticals Africa (Pty) Ltd 2nd Floor, Golden Oak House, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston 48/26/0047 148482 May 2028 1 vial 06 December 2024 Class II Type C 04 May 2026 Brief description of the problem (reason for recall) This recall is initiated...
Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Austell Pharmaceuticals (Pty) Ltd 1 Sherborne Road, Parktown, Johannesburg 38/20.1.1/0011 AEW014001 31 January 2028 10 Tablets 05 July 2024 Class III Type C 24 April 2026 Brief description of the problem (reason for recall) This recall is initiated due to: The inclusion of an...
