Regulatory Compliance Archives - Page 12 of 14

01 Oct Guideline on Traceability of Health Products

Posted at 14:31h in

The purpose of the document is to guide the implementation of global standards for product identification, data capture, and data sharing. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The implementation of unique...

24 Jun Report for Monitoring and Advertising of Promotional Material

Posted at 14:10h in

The role of the South African Health Products Regulatory Authority (SAHPRA) regarding advertising and marketing of medicines....

10 Mar Communication to Industry – Intention to Declare Medicines Compounded in terms of Section 14(4) Containing GLP-1or GLP-1/GIP Agonists Undesirable

Posted at 08:32h in

SAHPRA intends to declare medicines compounded in terms of Section 14(4) of the Medicines Act containing Glucagon-Like Peptide-1 (GLP-1) Active Components or a combination of Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide agonist (GIP) Active Components undesirable in terms of Section 23 of the Medicines...

25 Nov Absence of Border Medicines Control Technicians at the Ports of Entry on 29 November 2024

Posted at 14:10h in

The South African Health Product Regulatory Authority (SAHPRA) wishes to inform stakeholders that Border Medicines Control Technicians (BMCT) will not be physically present at the ports of entry on 29 November 2024 due to an Annual General Meeting at SAHPRA’s Head Office in Pretoria....

16 May Physical Resubmission of Shipment Documentation for SAHPRA Review and Stamp

Posted at 07:35h in

SAHPRA has taken office at the New Agents Building, 7th floor, Room 726. SAHPRA is instituting a physical resubmission process to address the backlog and new incoming shipments. Operating hours will be 08h00 to 15h45, in line with Border Management Agency (BMA) office hours....

10 May Delays in Shipment Release at OR Tambo International Airport

Posted at 09:57h in

The South African Health Products Regulatory Authority has experienced challenges in exercising its function to review and stamp the documents of incoming shipments of medicines, medical devices and scheduled substances at the OR Tambo International Airport port of entry. The delay has been caused by a...

20 Dec Post recall information/FINAL REPORT to SAHPRA

Posted at 06:43h in

20 Dec Recall Letter to customers

Posted at 06:42h in

20 Dec Recall Information

Posted at 06:40h in

Recall Information (INITIAL REPORT to SAHPRA)...

17 Jul Process Flow of Importation of Medical Products Published

Posted at 13:50h in

Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...

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