Marketing Authorisations (MA) granted in the Community shall have an initial duration of 5 years according to Regulation 19(1) of the Marketing Authorisation Regulations (Article 24(1) of Directive 2001/83/EC, as amended). After these 5 years, the MA needs to be renewed on the basis of a re-evaluation of the risk-benefit balance. An application for renewal of a MA shall include the below documents:
Signed covering letter in paper format (if submitting through CESP);
EU application form for renewal list of all post-authorisation submissions since authorisation/last renewal;
Certificate of compliance with Good Manufacturing Practice;
Quality overview (quality expert statement);
Addendum to clinical overview (if required);
Reports of post-marketing experience (PSURs).
The renewal application should be submitted according to the EU-CTD format. All the information can be sent electronically through CESP or if on DVD/CD, these should be accompanied by a signed cover letter.