Product information: Reference documents and guidelines

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This page lists the reference documents and guidelines on the quality of product information for centrally authorised veterinary medicines, including style, terminology, use of abbreviations and the translations of standard terms into European Union (EU) languages.

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Reference documents

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Committee for Medicinal Products for Veterinary Use (CVMP) scientific guidelines

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Document(s) Language Status First published Last updated Effective Date
Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products (English only)   2017-02-15    
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  
Questions and answers on how to express the frequency of adverse reactions within the product information (English only)   2016-07-25    
Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products (English only) draft: consultation closed 2016-07-25    
Concept paper on the need for revision of the position paper on indications for veterinary vaccines (English only) draft: consultation closed 2011-10-25    
Revised position paper on indications for veterinary vaccines (English only) adopted 2003-06-20    
Concept paper on concurrent administration of immunological veterinary medicinal products in view of determining day X to be 14 days and consequent revision of the summary-of-product-characteristics guideline for immunologicals (English only)   2006-04-21    
Guideline on the summary of product characteristics for anthelmintics (English only) adopted 2007-07-12   2008-01-31
Concept paper on the need to elaborate summary-of-product-characteristics guidance to minimise the development of anthelmintic resistance (English only)   2008-10-14    
Question and answer on the CVMP guideline on the summary of product characteristics for antimicrobial products (English only)   2011-07-20 2016-02-26  
Revised guideline on the summary of product characteristics for antimicrobial products (English only) adopted 2007-11-11   2008-05-01
Reflection paper on the use of fluoroquinolones in food-producing animals - precautions for use in the summary of product characteristics regarding prudent-use guidance (English only)   2006-11-08    

Reference information

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