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....
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...
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...
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. ...
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. ...
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...
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. ...
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)....
An application form for the purpose of obtaining a licence by a licensed wholesaler to export medicinal products (i.e. medicines and scheduled substances) in terms of the provisions of the Medicines and Related Substances Act, 101 of 1965, Section 22C and 22D read together with...
An application form for the purpose of obtaining a licence or renewing/amending 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...