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 (December 2022)