VII.C.8. Renewal of marketing authorisations

Marketing authorisations need to be renewed after 5 years on the basis of a re-evaluation of the riskbenefit balance in order to continue to be valid to place the product on the market. This renewal is irrespective of whether the marketing authorisation is suspended. Further details on the procedure and the documentation requirements can be found in the current versions of the “Guideline on Processing of Renewals in the Centralised Procedure” (EMEA/CHMP/2990/00) for Centralised products and the “CMDh Best Practice Guide on the processing of renewals in the MRP/DCP” (CMDh/004/2005) for other products.

No PSURs, addendum reports and summary bridging reports should be submitted within the renewal application. The clinical overview should include an addendum containing the relevant sections for the re-assessment of the risk-benefit balance of the medicinal product. These sections are identified in the above-mentioned guidelines for renewal. Marketing authorisation holders are advised to consider this GVP Module VII as guidance for the preparation of the addendum to the clinical overview.

Following the submission of a renewal application, the PRAC may be consulted for medicinal products authorised through the centralised procedure as regards safety issues. For nationally authorised products, including those authorised through the mutual recognition or decentralised procedure, the PRAC may also be consulted upon request by a competent authority in a Member State on the basis of safety concerns.

Conditional marketing authorisations should be renewed annually [REG Art 14(7)]. Further details on the procedure and the documentation to be submitted can be found in the “Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of regulation (EC) no 726/2004” (EMEA/509951/2006).