Renewal Procedure

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• 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 (March 2023) [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 (March 2023) [Track version]