Procedural Contact Points

Please open the link below for the following contact points:

 

  • General issues
  • Advice on MRP/DCP/SRP procedures
  • Advice on limited market procedures
  • Advice on exceptional circumstances procedure
  • Advice on the SPC harmonisation procedure
  • Submission of new applications, variations and renewals
  • Technical validation of e-Submissions
  • Submission of electronic response documents during MRP/DCP procedures
  • Issues regarding the naming of the VMP
  • Labelling and mock-ups, multilingual packs
  • Address for advice on fees & terms of payment
  • Pharmacovigilance procedures
  • Request for EU ASMF number
  • Request for the classification of a borderline product and EU borderline network contact points
  • UPD contact point

Procedural Contact Points (July 2022)