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. ...
To ensure continuity of supply of MeasBio for use in South Africa. Biovac obtained a Section 36 exemption from SAHPRA to supply the MeasBIO vaccine and the diluent for MeasBio packed in Indonesian National Agency for Food and Drug Control (NA-DFC) approved labelling with the...
We have in the past few weeks assisted several applicants that reached out to us, to retrieve old variations records attached to users that have been de-activated at an organisational level and we thought it best to issue this advice....
The Validation Template is used on receipt of an application to verify that all required information has been supplied to the South African Health Products Regulatory Authority (SAHPRA) in order to evaluate an application for the renewal of the certificate of registration of a medicinal...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, making provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences...
Stakeholders are hereby invited to provide comments to the draft SAHPRA’s Broad-Based Black Economic Empowerment Policy for issuance of new and the renewal of licences as per section 22C of the Medicines Act....
The following pharmaceutical companies, Adcock Ingram Limited, Teva Pharmaceuticals, Acino Pharma and Ranbaxy Pharmaceuticals, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to draw your attention to the following important safety information associated with bupropion-containing medicines registered in South Africa. The...
GSK South Africa, in collaboration with the SAHPRA, would like to draw your attention to the following important safety information associated with bupropion-containing medicines, registered in South Africa....
In response to the Supreme Court of Appeal (SCA) judgment on 11 April 2022 regarding the Alliance of Natural Health Products (ANHP), the Minister of Health recently released, for public comment, draft amendments to the General Regulations made in terms of the Medicines and Related...