Contact Points

Please open the link below for the following contact points:


  • Advice on MRP and DCP
  • Submission of new applications, variations and renewals
  • Submission of electronic response documents in MRP and DCP
  • Submission of Translations in MRP and DCP
  • Submission of Responses to List of Questions for Applications referred to the CMDh
  • Submission of Paediatric information in Member States
  • Request for Variation Grouping Number
  • Address for advice on fees
  • Terms of payment
  • PSUSA/PSUR Worksharing Project
  • Request for EU ASMF number
  • Technical validation of e-Submissions
  • Requests for the composition of a product used in a bioequivalence study
  • Requests for information on a product for which a parallel import license is requested
  • Switch of the RMS
  • Requests to act as reference authority in a variation worksharing procedure
  • Publication of product information by NCAs