General ECTD & human medicines Archives

14 Oct Notice on Variation Applications: Extension of Submission Window for Type II Variations Pilot Project

Posted at 13:02h in

The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants and holders of certificates of registration that the submission window for Type II Variations Pilot Project, including related changes bundled variations submissions, has been extended to Friday, 30 October 2026....

13 Oct Guideline on the Quality and Clinical Aspects of Synthetic Peptides

Posted at 11:27h in

This guideline provides recommendations to applicants who wish to submit application for the registration of synthetic peptide medicines. The South African Health Products Regulatory Authority (SAHPRA) is committed to the safety, quality and efficacy of medicines. This document should be regarded as recommendations not as...

12 Oct Riqviva 100 and 400 (Bevacizumab)

Posted at 10:42h in

Company name & Address: Registration number Batch number Expiry date Pack size First Distribution date Re-call Classification Recall date Dr Reddys Laboratories (Pty) Ltd Block C, Woodmead North Office Park, 54 Maxwell Drive, Woodmead Sandton, Gauteng South Africa 56/26/0604 56/26/0605 N250621B N250634A 07/2028 08/2028 Vial 5ml & 20ml 30 November 2025 23 January 2026 Class II Type B 07 October 2026 Brief description of the problem (reason...

29 Sep Complementary Medicines (Multiple products)

Posted at 11:54h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Natural Medicinal Services (Pty) Ltd 49 Roberts Avenue Kensington Johannesburg 2094 N/A As per recall letter Addendum B All per recall letter Addendum B As per recall letter Addendum B As per recall letter Addendum B Class III Type A 22 September 2026 Brief description of the...

29 Sep Ciplavasc 5 (Amlodipine besylate 5mg)

Posted at 11:51h in

Company name & Address: Registration number Batch number Expiry date Pack size First Distribution date Re-call Classification Recall date Cipla Medpro (Pty) Ltd. Building 2 Junxion Park 10 Elephant Lane Century City South Africa 7441 A 39/7.1/0117 ZA260565 May 2029 30’s 22 July 2026 Class I Type B 25 September 2026 Brief description of the problem (reason for recall) Cipla Medpro (Pty) Ltd., in collaboration with the South...

29 Sep Eribulin DRL (Eribulin Mesylate)

Posted at 11:46h in

23 Sep Diamet XR 1000 (Metformin Hydrochloride)

Posted at 08:48h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date 100 Northern Parkway Rd Crownwood Office, Block D Groundfloor Ormonde 20291 57/21.2/0123 5251059 September 2028 60’s April 2026 Class III Type C 17 September 2026 Brief description of the problem (reason for recall) This recall is initiated because one side panel of the carton (secondary packaging) incorrectly...

22 Sep Guideline for Selection of Reference Products for Applications of Generic Medicines

Posted at 11:38h in

This document guides applicants who seek to apply for new registration of generics supported by Bioequivalence studies. The South African Health Products Regulatory Authority (SAHPRA) can request additional information to establish whether the health products meet the safety, quality and performance standards. While other approaches...

04 Sep Frequently Asked Questions (FAQ) – Oral Phenylephrine-Containing Products

Posted at 10:56h in

This document consolidates SAHPRA’s responses to questions received from industry stakeholders following its 30 July 2026 communication regarding the lack of effectiveness of oral phenylephrine as a nasal decongestant....

03 Sep Medicines Registry and eCTD Take-On Programme

Posted at 12:27h in

Following the Engagement Portal webinar of 26 August 2026, this communication sets out the key activities and dates for the two programmes that sit with Health Products Authorisation (HPA) and confirms the requirements for their completion....

Archive