Application guidance

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The European Medicines Agency provides guidance documents to companies and individuals involved in developing and marketing veterinary medicines in the European Union. These include guidance on dossier requirements, submission dates, procedures as well as templates and checklists for applications.

The Notice to Applicants (NtA) is intended to facilitate the interpretation and application of the Community pharmaceutical legislation. It has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency. It is not legally binding, and in case of doubt, applicants should refer to the appropriate Community Directives and Regulations.

From 1 January 2016 the use of electronic Application Forms (eAF) is mandatory for all application procedures (authorisations, variations and renewals).  

As of 1 January 2017 it is mandatory for applicants to use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see:

Table of contents


Dossier requirements and recommended submission dates

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Related links

Guidance

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Document(s) Language Status First published Last updated Effective Date
Guidance to applicants / marketing authorisation holders on oral explanations at CVMP (English only)   2017-02-24    
Validation checklist for initial marketing authorisation applications – immunologicals (applicable to submissions under Art. 12(3) of Directive 2001/82) (English only)   2015-06-30    
Validation checklist for initial marketing authorisation applications – pharmaceuticals (applicable to submissions under Art. 12(3) of Directive 2001/82) (English only)   2015-06-30    
Formatted table template to be inserted in application submission cover letters for veterinary procedures (English only)   2017-04-28    
Pre-submission instruction on the detailed description of the pharmacovigilance system of a marketing authorisation holder; to be submitted with a marketing authorisation application for a veterinary medicinal product (English only) adopted 2012-03-01    
Summary of procedures for consultation by the Committee for Medicinal Products for Veterinary Use of scientific advisory groups (SAGs) and ad-hoc expert groups functioning as SAGs in relation to applications for authorisation of veterinary medicinal products (English only) adopted 2011-04-07    
Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure (English only) adopted 2008-01-21 2013-05-02  
The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products (English only) adopted 2007-02-01 2014-04-01 2014-04-01
Mock-up/specimen submission form (English only)   2008-11-24    
Guideline on the procedure for accelerated assessment pursuant to Article 39 (8) of Regulation (EC) no 726/2004 (English only) adopted 2006-05-18   2006-05-22
Procedural announcement: Request for applicants to submit a complete set of annexes for all future procedures (English only) adopted 2004-03-18