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29 Apr

Posted at 08:28h in

This document is intended to provide communication to industry on the changes of EDQM CEP and implementation of CEP 2.0 for all other new applications for orthodox medicines. This will be a “living document” and will be updated in line with changes observed from the...

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 SAHPRA in order to evaluate an application for the renewal of registration of a medicinal product for human or veterinary use submitted in eCTD format....

08 Jun

Posted at 16:33h in

This document is set to provide a summary of the frequently asked questions regarding the Medicine Registration Renewals Process ensuring a consistent approach to benefit all stakeholders to ensure quality, efficacious and safe products are available to the public....

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....