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.

Table of contents


Reference documents

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Document(s) Language Status First published Last updated Effective Date
Quality review of documents (QRD) template ‘Particulars to appear on the immediate package – combined label and package leaflet’ for veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures. (English only) draft: consultation open 2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet BG = bălgarski   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet ES = español   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet CS = čeština   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet DA = dansk   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet DE = Deutsch   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet ET = eesti keel   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet EL = elliniká   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet EN = English   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet FR = français   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet IT = italiano   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet LV = latviešu valoda   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet LT = lietuvių kalba   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet HU = magyar   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet MT = Malti   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet NL = Nederlands   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet PL = polski   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet PT = português   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet RO = română   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet SK = slovenčina   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet SL = slovenščina   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet FI = suomi   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet SV = svenska   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet HR = Hrvatski   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet IS = Islenska   2017-04-03    
Particulars to appear on the immediate package – combined label and package leaflet NO = Norsk   2017-04-03    
List of official languages per country (English only)   2012-04-04 2013-11-22  
Abbreviation of names of days on calendarised blisters (English only)   2012-04-04    
Tables of non-standard abbreviations to be used in the summary of product characteristics (English only)   2009-04-01 2012-06-26  
Compilation of Quality Review of Documents decisions on stylistic matters in product information (English only)   2008-02-01 2015-06-10  
Compilation of Quality Review of Documents decisions on the use of terms (English only)   2005-12-01 2011-03-28  
Names of the European Union / European Economic Area countries (English only)   2008-07-23 2015-04-08  
Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates (English only) adopted 2007-06-01 2011-04-15 2007-06-01
Packaging ‘blue-box’ requirements and additional information on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures (English only)   2015-03-10    
Draft QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP) (English only) draft: consultation closed 2016-11-25    

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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