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03 Oct

Posted at 10:47h in

SAHPRA has launched an Online Medicines Directory. Please visit: www.medsinfo.sahpra.org.za   The Online Medicines Directory has been launched for Schedule 0-2. The job is to increase awareness and use of the directory amongst consumers, patients and healthcare providers. This toolkit provides Market Authorisation Holders (MAH) and SAHPRA...

11 Jul

Posted at 14:28h in

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....

11 Jul

Posted at 10:57h in

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...

26 May

Posted at 14:30h in

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....

03 May

Posted at 14:24h in

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....

04 Apr

Posted at 09:44h in

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...