General Information on Applications

 

e-SUBMISSION
Please open the link above for further information

 

Documents relating to the former Chapter 7 of the Notice to Applicants provided by the European Commission

The information regarding veterinary medicinal products authorised nationally (Mutual Recognition Procedure/Decentralised Procedure) contained in Chapter 7 - General Information of the Notice to applicants - had been transferred to the CMDv website respectively.

Documents

Format and no. of copies for new MA applications
Updated September 2017

Payment terms & addresses for national fees
Updated April 2017 EL, NO, SE

Addresses for delivery and other contact points
Updated April 2017 DE-BVL, EL, PL, SE, SK, UK

Packaging 'blue-box' requirements in MRP/DCP
Clean version updated May 2017 with DK, FI, FR, NO, RO, SE, UK data

Packaging 'blue-box' requirements in MRP/DCP
Tracked changes version updated May 2017 with DK, FI, FR, NO, RO, SE, UK data

 

Documents on national requirements

Member States' additional national requirements for submission
Updated March 2017

 

National fees
Please inform the CMDv secretariat if you find a link that does not work

Austria (AT - EN version), Belgium (BE), Bulgaria (BG), Croatia (HR), Cyprus (CY), Czeck Republic (CZ - EN version), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany - PEI (DE), Germany - BVL (DE), Greece (EL), Hungary (HU), Iceland (IS), Ireland (IE), Italy (IT), Latvia (LV), Liechtenstein (LI - No fees regarding DCP/MRP applications due to an agreement between LI and AT. This agreement allows LI to accept marketing authorisations issued by the Austrian authority (AGES) for the MRP/DCP procedures, provided the applicant wishes to have LI included), Lithuania (LT), Luxembourg (LU), Malta (MT), Netherlands (NL), Norway (NO), Poland (PL), Portugal (PT), Romania (RO), Slovakia (SK), Slovenia (SI), Spain (ES), Sweden (SE), United Kingdom (UK)