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23 Sep

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

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...

03 Sep

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....

28 Aug

Posted at 18:08h in

In the communication dated 30 July 2026 (COMM Issue No. CLINPR_06_2026_27_Final.pdf), SAHPRA notified all Holders of Certificates of Registration (HCRs) of the final regulatory position regarding orally administered phenylephrine-containing medicines. HCRs were required to notify SAHPRA in writing of their chosen pathway (effectiveness study or...

27 Aug

Posted at 08:44h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Zydus Healthcare SA (Pty) Ltd Southdowns Office Park, Building A, 2nd Floor 22 Karee Street Centurion 0157   44/7.1.3/0503 MA04847A MB02129A MA04848A MA04900A MB02127A MB02128A MA04847A Exp.10/2028  MB02129A Exp.02/2029 MA04848A Exp.10/2028 MA04900A Exp.10/2028 MB02127A Exp. 02/2029 MB02128A Exp. 02/2029     30’s MA04847A - 12/02/2026 MB02129A - 06/05/2026 MA04848A - 19/01/2026 MA04900A - 12/02/2026 MB02127A - 06/05/2026 MB02128A -...

26 Aug

Posted at 18:01h in

This guideline provides information on the process to be followed when the appropriate regulatory pathway for a specific product is unclear. It also outlines the criteria to be applied to determine whether the product is regulated in terms of the Medicines and Related Substances Act,...

21 Aug

Posted at 16:20h in

This template shall be used on receipt of a new human medicine application for registration to verify that all the required information for evaluation has been provided to SAHPRA. It is also used for follow-up sequences that may be required for the new registration.  ...

18 Aug

Posted at 08:46h in

Company name & Address: Registration number Batch number(s) Registered Expiry Date (Labelled Expiry Date) Pack size First release date Re-call Classification Recall date Fresenius Kabi South Africa (Pty) Ltd 7 Kingfisher Avenue Midpoint 162 Tonetti Street Halfway House Ext. 7, Midrand Gauteng, 1685 PO Box 4156 Halfway House Gauteng, 1685   K/18.1/207 90TEA870 90TIA300 90TKB190 90TLA480 90UCA000 90UEA840 90UIA510 90UIA530 90WEA230   30 April 2027 (30 April 2029) 31 August 2027 (31 August 2029) 30...