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The CMDh has introduced a Request Form for an MRP/RUP procedure available for the National Competent Authorities (NCA). Due to the different organisations and thereby also different working procedures for the approved medicinal products in member states, the Request form may need to be adapted at national level and is not mandatory for the NCAs to use. The Request Form is published on the CMDh website to be transparent, but marketing authorisation holders should approach the reference member state to discuss update of the AR in the MRP/RUP procedure as appropriate and use the request form available from the RMS if applicable. For further guidance the CMDh refers to the NCAs websites.
After a pilot period of maximum 1 year the Request form will be revisited.