Application guidance (veterinary medicines)
Table of contents
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 use of electronic Application Forms (eAF) is mandatory for all application procedures (authorisations and variations requiring assessment).
It is also 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:
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Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (PDF/304.13 KB)
First published: 18/11/2009
Last updated: 31/01/2023
EMA/466102/2007 Rev. 34 -
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Recommended submission dates for veterinary medicinal products (PDF/688.86 KB)
Adopted
First published: 01/07/2009
Last updated: 08/06/2022
EMA/587410/2021 Rev.5
- Information on summary of product characteristics requirements can be found in the veterinary Product information requirements page - Quality review of documents (QRD) section.
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Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6 (PDF/277.29 KB)
First published: 17/07/2006
Last updated: 22/04/2022
EMA/CVMP/32995/2006 Rev. 1 -
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Change of applicant - Cover letter standard text (veterinary) (DOCX/20.88 KB)
First published: 01/10/2018
Last updated: 03/05/2022 -
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Change of applicant checklist - pre-submission guidance (veterinary) (PDF/178.27 KB)
First published: 01/10/2018
Last updated: 03/05/2022
EMA/603587/2018 -
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Guidance to applicants / marketing authorisation holders on oral explanations at CVMP (PDF/89.91 KB)
First published: 24/02/2017
Last updated: 24/02/2017
EMA/CVMP/519444/2016 -
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Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6) (PDF/485.48 KB)
First published: 15/06/2022
EMA/278419/2022 Rev.1 -
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Validation checklist for initial marketing authorisation applications – immunologicals (applicable to submissions under Regulation (EU) 2019/6) (PDF/494.6 KB)
First published: 30/06/2015
Last updated: 10/03/2022
EMA/377884/2015 Rev. 2 -
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Validation checklist for initial marketing authorisation applications – pharmaceuticals (applicable to submissions under Regulation (EU) 2019/6) (PDF/597.42 KB)
First published: 30/06/2015
Last updated: 10/03/2022
EMA/377885/2015 Rev. 2 -
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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 authoris... (PDF/105.01 KB)
Adopted
First published: 07/04/2011
Last updated: 07/04/2011
EMA/347137/2010 -
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Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure (PDF/160.82 KB)
Adopted
First published: 21/01/2008
Last updated: 02/05/2013
EMEA/CVMP/328/98 Rev. 3 -
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The checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products (PDF/219.81 KB)
Adopted
First published: 01/02/2007
Last updated: 02/02/2022
EMA/14522/2007 Rev.3