Guidance documents
This page lists the European Medicines Agency's general guidance documents relating to veterinary medicines.
If you have comments on a document that is open for consultation, use the template and send it to vet-guidelines@ema.europa.eu.
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Questions and answers on mentioning solvents in the product information of veterinary medicinal products authorised via the centralised procedure (PDF/111.16 KB)
Adopted
First published: 18/12/2015
Last updated: 25/07/2016
Consultation dates: 18/12/2015 to 31/03/2016
EMA/CVMP/550607/2015 -
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Concept paper on a revision of the guideline for an assessor preparing assessment reports (PDF/37.71 KB)
Draft: consultation closed
First published: 19/10/2009
Last updated: 19/10/2009
Consultation dates: 01/10/2009 to 31/12/2009
EMEA/CVMP/626480/2009 -
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Concept paper on the classification of veterinary medicinal products authorised by the community (PDF/66.21 KB)
First published: 18/09/2007
Last updated: 18/09/2007
EMEA/CVMP/358850/2007-CONS -
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Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur (according to Article 62 (1) of Regulation (EC) No 726/2004) (PDF/237.29 KB)
Adopted
First published: 23/09/2009
Last updated: 20/09/2019
Legal effective date: 23/09/2009
EMA/CVMP/468877/2009 Rev. 2 -
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Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur (according to Regulation (EU) 2019/6) (PDF/250.1 KB)
Adopted
First published: 12/01/2022
Legal effective date: 23/09/2009
EMA/CVMP/468877/2009 - Rev. 3 -
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Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework (PDF/102.39 KB)
Adopted
First published: 18/03/2009
Last updated: 18/03/2009
Legal effective date: 01/09/2005
EMEA/P/24143/2004 Rev. 1 corr -
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Procedure to be followed to facilitate communication and dialogue between the CVMP and the interested parties (PDF/48.33 KB)
Adopted
First published: 06/06/2006
Last updated: 06/06/2006
Legal effective date: 18/10/2004
EMEA/CVMP/329/04-Rev.1
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CVMP analysis of the functioning of current veterinary legislation and proposals for its evolution and comments on the Commission paper (PDF/225.3 KB)
First published: 19/07/2010
Last updated: 19/07/2010
EMA/CVMP/463298/2010 -
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Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6 (PDF/183.62 KB)
Draft: consultation closed
First published: 20/07/2020
Consultation dates: 20/07/2020 to 21/09/2020
EMA/CVMP/340959/2020
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Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EC) No 726/2004) (PDF/253.81 KB)
First published: 20/11/2017
Last updated: 11/09/2020
EMA/CVMP/321528/2017 Rev. 1 -
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Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EU) 2019/6) (PDF/239.16 KB)
First published: 12/01/2022
EMA/CVMP/321528/2017 Rev. 2
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Reflection paper on publication of withdrawals of marketing authorisation applications for veterinary medicinal products (PDF/65.37 KB)
Adopted
First published: 22/06/2009
Last updated: 22/06/2009
EMEA/CVMP/425558/2006-Rev.1 -
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Overview of comments received on reflection paper on publication of withdrawals of marketing authorisation applications for veterinary medicinal products (PDF/67.51 KB)
First published: 12/07/2007
Last updated: 12/07/2007
EMEA/CVMP/247808/2007
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Reflection paper on the publication of the CVMP’s negative opinion and refusal to recommend the granting of a marketing authorisation for veterinary medicinal products (PDF/73.57 KB)
Adopted
First published: 12/07/2007
Last updated: 12/07/2007
EMEA/CVMP/459912/2006 -
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Overview of comments received on reflection paper on publication of the CVMP’s negative opinion and refusal to recommend the granting of a marketing authorisation for veterinary medicinal products (PDF/64.48 KB)
First published: 12/07/2007
Last updated: 12/07/2007
EMEA/CVMP/247827/2007
- Criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6
- Reflection paper on the application of Regulation (EU) 2019/6 for certain categories of variations
- Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products
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Common Repository for all veterinary submissions in the centralised procedure – statement of intent (PDF/69.1 KB)
First published: 25/11/2016
Last updated: 25/11/2016
EMA/715059/2016 -
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Overview of comments received on VICH guideline on electronic exchange of documents electronic file format (GL53) (PDF/363.45 KB)
First published: 29/05/2015
Last updated: 29/05/2015
VICH GL-53 -
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Final VICH GL53: Electronic exchange of documents: electronic file format (PDF/187.19 KB)
Adopted
First published: 20/03/2015
Last updated: 01/10/2015
EMA/CVMP/VICH/758781/2013 Corr. 1 -
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Use of eSubmission Gateway / Web Client extended to new procedure types from 1st of April 2014 (PDF/102.66 KB)
First published: 01/04/2014
Last updated: 01/04/2014
EMA/71358/2014 -
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Template - Framework for a correlation table (notice to applicants: Common Technical Document (CTD)) for active-substance master files / part 2 in CTD format for dossiers for veterinary medicinal products (PDF/67.86 KB)
First published: 22/05/2012
Last updated: 22/05/2012
EMA/115282/2012
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: