This notice provides an update regarding the continuation of the Type II Variations Pilot Submission Windows and introduces specific process enhancements....
The South African Health Products Regulatory Authority (SAHPRA) has released the updated eCTD defined lists and document matrices, effective 10 October 2026. The update includes 31 new submission types (sub-type-51 to sub-type-81) and new entries in the application type, sequence type, submission lead and evaluation...
Company name & Address: registration number Batch number(s) Expiry date Pack size First distributed Re-call Classification Recall date Ascend Laboratories Pty Ltd Sandton City Office Towers, 83 Rivonia Road and 5th street, 7th Floor, Sandton 2196 49/2.5/1167 49/2.5/1169 24142840 24142842 06/2027 06/2027 100’s Blister 100’s Blister December 2024 Class II Type B 22.October.2026 Brief description of the problem (reason for recall) This recall was initiated as...
The Authority has received requests from applicants for additional time to complete the Medicines Registry linkage and IDMP data requirements that were communicated following the Engagement Portal webinar of 26 August 2026. This notice shall be read in conjunction with Communication Issue No.: HPA18-2026/27...
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....
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...
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...
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...
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...
Company name & Address:Registration numberBatch numberExpiry datePack sizeFirst Distribution dateRe-call ClassificationRecall dateDr Reddys Laboratories (Pty) Ltd Block C, Woodmead North Office Park, 54 Maxwell Drive, Woodmead Sandton, Gauteng South Africa 57/26/0539 H260193 November 2027 2ml Vial 26 May...