EMA: Draft guideline on the processing of renewals in the centralised procedure

This guideline considers issues associated with the processing of renewals in the centralised procedure, with an aim of giving procedural guidance to marketing authorisation holders (MAHs). It has been developed by the CHMP following consultation of the interested parties and the European Commission Services. This guideline is not legally binding, and in case of doubt, reference should be made to the appropriate EU Directives and Regulations. This document should be read in connection with the Notice to Applicants’ documents. Renewal of conditional marketing authorisations (i.e. only valid for one year) is not covered in this guideline. Guidance regarding renewal of such marketing authorisation is provided in a separate document. Marketing authorisations approved under exceptional circumstances are covered by this guideline.

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