The Qualified Person's declaration template
The Qualified Person's declaration template
Electronic Application Form
Information related to the CESSP project is available on the CESSP eSubmission website and on the EMA website
Applications
CMDv/GUI/014: GUIDANCE for The Processing of Generic Applications Through MRP / DCP – updated November 2015
CMDv/GUI/014: GUIDANCE for The Processing of Generic Applications Through MRP / DCP – updated November 2015 – TRACK CHANGES
ASMF procedure
National fees
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)
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