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 - Article 46
• Submission of Paediatric information in Member States Articles 45 and 46
• Request for Variation Grouping Number
• Address for advice on fees
• Terms of payment
• PSUSA
• 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