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 document is intended to provide guidance to stakeholders on the use of the newly implemented QOS and QIS....
This form is to be completed by the applicant/holder of a certificate of registration/principal from whom the document was purchased for submission in South Africa, based on which party submitted the dossier to the RRA....
This document is for use of all products including Biologics and veterinary products, where the information is not applicable for the specific molecule; indicate "N/A". Veterinary medicine applicants are advised to also refer to the VICH guidelines....
This document is for use of all products including Biologics and veterinary products....
This template has been updated to conform to the new SAHPRA document format....
The guideline is intended to provide guidance with regard to the legal system of measurement in South Africa. The guideline reflects the requirements as stipulated in the Legal Metrology Act, 2014 (Act 9 of 2014), and the Measuring Units and Measuring Standards Act, 2006 (Act...
Please note that SAHPRA will continue to communicate registration certificates for both new medicines and relevant type || variation applications via e-mail to applicants until further notice....
This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...
