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New guideline: renewal of marketing authorisation for nationally authorised medicinal products

10 December 2012

The documentation to be submitted with an application to renew a marketing authorisation for nationally authorised medicinal products now follows the rules which apply to the mutual recognition procedure and the decentralised procedure. Likewise, an application for renewal of a marketing authorisation must be made using the EU form.

Further information is available in Guideline on application for renewal of marketing authorisation