Archive

Home >  (Page 11)

27 Apr

Posted at 12:42h in

  Company name & Address:   registration number   Batch number   Expiry date   Pack size   First distributed   Re-call Classification   Re-call Date   Ascendis Health Ltd 31 Georgian Crescent East Bryanston, South Africa   0.5 mg: 45/2.5/0820   7862006-8 (3 batches)   July-2022   84’s (Carton with Blister)   12.July.2019   Class II Type B 20 September 2021   2 mg: 45/2.5/0821   7872005-6 (2 batches)   June-2022, July- 2022   84’s (Carton with Blister)   12.July.2020   Class II Type B 20 September 2021   *CLONAM 0.5mg and CLONAM 2 mg are both on state...

27 Apr

Posted at 12:41h in

Company name & Address   registration number   Batch number   Expiry date   Pack size   First distributed   Re-call Classification   Re-call Date UNICORN PHARMACEUTICALS (PTY) LTD CNR SEARLE AND PONTAC STREETS, CAPE TOWN, 8001   50 mg: 46/7.1.3/0714   LS220001A   July-2022   30   12/11/2020   Class II Type B   31 August 2021   100 mg: 46/7.1.3/0715   LS320002A   June-2022   30   30/11/2020   Class II Type B   31 August 2021   Reason for recall The products are being recalled due to quality defect: the presence of...

27 Apr

Posted at 12:39h in

Company name & Address   registration number   Batch number   Expiry date   Pack size   First distributed   Re-call Classification   Re-call Date Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South Africa   41/34/0573- 41/34/0572   18069   31Aug-2021 Starter Pack 0.5mg/1mg Film Coated Tablet 1×11+3×14   12 Apr-2019   Class III Type B   19 August 2021   Reason for recall Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily...

25 Mar

Posted at 11:24h in

This communication is intended to inform the relevant GDP license holders of the one-time renewal of expired GDP resolution letters. SAHPRA is introducing this initiative as a targeted measure to strengthen compliance management while addressing operational challenges.   Frequently Asked Questions (FAQ): One-Time Renewal of Expired GDP...

18 Dec

Posted at 08:27h in

With reference to the communication issued on 30 June 2025 (HPA05-2025/26, Version 5), SAHPRA wishes to inform all holders of certificates of registration that the current predefined submission window for Type II variation applications (including related changes bundled variation submissions) within the period 02 January...

18 Nov

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

10 Nov

Posted at 08:57h in

This document provides guidance regarding safe disposal and destruction of medicines and scheduled substances by health facilities in accordance with Regulation 44 of the General Regulations of the Medicines and Related Substances Act, 101 of 1965, and relevant waste legislation. To ensure the correct handling...

01 Oct

Posted at 14:35h in

Dear Applicants, This roadmap outlines the phased implementation of unique product identification requirements for all health products in South Africa, transitioning from batch-level to unit-level serialisation across primary, secondary, and tertiary packaging levels....