General ECTD & human medicines Archives - Page 2 of 24

28 Aug Extension of Notification Deadline – Oral Phenylephrine Pathway Selection

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 Ciplasyl Plus 4 tablets

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 Guideline for Borderline Products

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 Screening Report for New Medicine Applications for Registration

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. ...

21 Aug Call for Stakeholders to Verify Their Records – Missing Applications for Variations

Posted at 13:51h in

The South African Health Products Regulatory Authority (SAHPRA) calls on industry stakeholders to verify their records and identify any variation applications that may have been submitted but remain unprocessed due to the transition to the new system. The applications that may have been affected were...

18 Aug Frusemide 20 mg/2 ml Fresenius (Furosemide)

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...

13 Aug Guideline for Health Product Traceability: Update on Implementation

Posted at 15:24h in

As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...

12 Aug General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965: Amendment to Regulation 6: Notice of Correction

Posted at 11:43h in

The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...

11 Aug Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestants

Posted at 09:32h in

This communication serves as a formal update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine‑containing medicines following the consultative meeting held on 24 April 2026 and subsequent internal deliberations by the Authority....

02 Aug Enalapril 10mg Arya

Posted at 21:05h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Arya Pharma Pty Ltd Pharma HQ, Corner Barbara and North Reef Road, Elandsfontein, Germiston, Gauteng, 1601. 37/7.1.3/0328 GQQ24066 GQQ24064 GQQ24067 GQQ24053 GQQ24066 (Sep-2026) GQQ24064 (Sep-2026) GQQ24067 (Sep-2026) GQQ24053 (Aug-2026) 28’s GQQ24066 (Jan-2025) GQQ24064 (Jan-2025) GQQ24067 (July-2025) GQQ24053 (Jan-2025) Class II Type A 29 July 2026 Brief description of the problem (reason for recall) Quality defect: This recall...

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