Renewal Procedure

In order to view some of the documents on this website you need Acrobat Reader
(click here to download)

• CMDh Best Practice Guide on the processing of renewals in the MRP/DCP (February 2023) [Track version]

• Common grounds seen for delaying Day 0 Renewals (July 2017) [Track version]

• Data requested for Variations and/or Renewal Applications in the MRP/DCP

• Requirements on submissions for Variations and Renewals within MRP and National Procedures

• Languages to be used for Marketing Authorisation Application (MAA), Variations and Renewals

• Mock-ups, Specimens and Samples for variations and renewals

• Member State agreement upon conditions under which the RMS can start renewal procedures (July 2017) [Track version]