EDQM CEP 2.0 Implementation

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 EDQM. It is important that Applicants adhere to the regulatory requirements to avoid delays in the evaluation of applications. This document should be used in conjunction with SAHPRA’s BE & Quality guideline and CEP letter of access template available from SAHPRA’s website.