Archive

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...

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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....

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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....

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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...

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24 Apr Licence Application for the Importing and the Distribution Scheduled Substances

Posted at 11:21h in

An application form to obtain a licence or renew/amend a licence in terms of the provisions of the Medicines and Related Substance Act, 1965 Section 22C and 22D read together with Regulation 23 and 24 of the General Regulations to the Medicines Act as the case...

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06 Dec Cannabis Pre Licence Application Status Letter

Posted at 08:44h 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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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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13 Jun Retention Fee Notification – 9 June 2022

Posted at 16:03h in

Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...

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03 Jun Communication to Industry – Applications for GMP and CPP Certificates

Posted at 14:35h 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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30 Mar Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines

Posted at 09:35h in

As of the 1st of April 2022, the post-importation testing exemption requests for Biological and Biosimilar medicines should be submitted as per the requirements of Guideline 2.04. For submission process, please refer to section 3.0 Post-Importation Testing Exemptions (PITE)....

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