Guidance documents

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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 form for submission of comments on scientific guidelines and send it to vet-guidelines@ema.europa.eu.

Table of contents


General

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on mentioning solvents in the product information of veterinary medicinal products authorised via the centralised procedure (English only) adopted 2015-12-18 2016-07-25  
Guideline on the principles for preparing assessment reports for veterinary medicinal products (English only) adopted 2015-12-18   2016-01-01
Checklist on information / elements that should be provided by marketing-authorisation holders in their detailed descriptions of the pharmacovigilance system for competent authorities’ assessment (veterinary medicinal products) (English only)   2012-12-10    
Concept paper on a revision of the guideline for an assessor preparing assessment reports (English only) draft: consultation closed 2009-10-19    
Guideline for an assessor preparing assessment reports for veterinary medicinal products (English only) adopted 2005-05-28   2005-05-28
Concept paper on the classification of veterinary medicinal products authorised by the community (English only)   2007-09-18    
European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (English only) adopted 2009-03-27    
Request to CMDh / CMDv / European Medicines Agency for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (English only)   2009-03-01 2013-08-29  
Reflection paper on risk-management plans for centrally authorised veterinary medicinal products (English only) adopted 2012-02-15    
Overview of comments received on the CVMP reflection paper on risk-management plans for centrally authorised veterinary medicinal products (English only)   2012-02-15    
Reflection paper on risk-management plans for centrally authorised veterinary medicinal products (English only) draft: consultation closed 2009-11-17    
Practical guidance on the extension of Commission-decision annexes in the new accession-country languages (English only) adopted 2004-05-07   2004-05-07
Appointment and responsibilities of rapporteur and co-rapporteur for procedures regarding veterinary medicinal products (English only) adopted 2009-09-23 2015-04-09 2009-09-23
Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework (English only) adopted 2009-03-18   2005-09-01
Procedure to be followed to facilitate communication and dialogue between the CVMP and the interested parties (English only) adopted 2006-06-06   2004-10-18

Future pharmaceutical legislation

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Document(s) Language Status First published Last updated Effective Date
CVMP analysis of the functioning of current veterinary legislation and proposals for its evolution and comments on the Commission paper (English only)   2010-07-19    

Sunset-clause provision

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Procedures for re-examination

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Document(s) Language Status First published Last updated Effective Date
Procedural advice on the re-examination of CVMP opinions (English only) adopted 2009-09-23   2007-09-17
Guideline on procedures for re-examination of CVMP opinions (English only) adopted 2007-09-18   2007-09-17
Overview of comments received on draft guideline on procedures for re-examination of CVMP opinions (English only)   2007-09-18    

Publication of withdrawals

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Publication of refusals

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Phasing-in of new legislation

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Good manufacturing practice (GMP): Questions and answers on audits of active-substance manufacturers

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Undesirable effects on the environment

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Document(s) Language Status First published Last updated Effective Date
Reflection paper on the implementation of Directive 2001/82/EC, as amended, in respect to the assessment of environmental risks of veterinary medicinal products (English only) draft: consultation closed 2008-03-14    

Related links

Following the consultation period, the Agency finalised the reflection paper above and submitted it to the European Commission, which published it in volume 6: notice to applicants and regulatory guidelines for medicinal products for veterinary use.

Benefit-risk balance

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Electronic submissions

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Related links

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:

Accelerated assessment

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Document(s) Language Status First published Last updated Effective Date
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