Product-information templates

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This page lists the templates for product information for use by applicants and marketing-authorisation holders of veterinary medicines. The European Medicines Agency's Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.

The information contained in these documents is non-exhaustive. Companies should refer to all relevant European Union legislation and guidelines when drawing up applications. It is the company’s responsibility to ensure that the product information complies with all such requirements.

Latest updates: August 2014

  • New Appendix IV on terms and abbreviations for batch number and expiry date to be used on the labelling.

Any further changes affecting some or all of the linguistic versions of the templates will be published on this page.

Maltese fonts

Maltese fonts are built in to Windows XP SP3 and higher.

Table of contents


Centralised procedures

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Document(s) Language Status First published Last updated Effective Date
Quality Review of Documents veterinary product-information annotated template (English) version 8 - clean (English only)   26/10/2012 05/11/2012  
Quality Review of Documents veterinary product-information annotated template (English) version 8 - highlighted (English only)   19/12/2008 05/11/2012  
Implementation plan (veterinary) (English only)   26/10/2012    
Quality Review of Documents veterinary product-information template version 8 BG = bălgarski   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 ES = español   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 CS = čeština   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 DA = dansk   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 DE = Deutsch   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 ET = eesti keel   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 EL = elliniká   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 EN = English   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 FR = français   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 IT = italiano   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 LV = latviešu valoda   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 LT = lietuvių kalba   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 HU = magyar   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 MT = Malti   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 NL = Nederlands   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 PL = polski   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 PT = português   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 RO = română   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 SK = slovenčina   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 SL = slovenščina   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 FI = suomi   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 SV = svenska   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 HR = Hrvatski   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 IS = Islenska   08/04/2010 05/11/2012  
Quality Review of Documents veterinary product-information template version 8 NO = Norsk   08/04/2010 05/11/2012  
Quality Review of Documents veterinary annex-A template BG = bălgarski   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template ES = español   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template CS = čeština   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template DA = dansk   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template DE = Deutsch   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template ET = eesti keel   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template EL = elliniká   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template EN = English   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template FR = français   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template IT = italiano   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template LV = latviešu valoda   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template LT = lietuvių kalba   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template HU = magyar   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template MT = Malti   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template NL = Nederlands   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template PL = polski   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template PT = português   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template RO = română   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template SK = slovenčina   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template SL = slovenščina   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template FI = suomi   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template SV = svenska   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template HR = Hrvatski   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template IS = Islenska   19/06/2009 24/01/2014  
Quality Review of Documents veterinary annex-A template NO = Norsk   19/06/2009 24/01/2014  

Appendices

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Document(s) Language Status First published Last updated Effective Date
Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of veterinary medicinal products (English only)   01/08/2014    

European Union enlargement: Product-information templates translated into Croatian

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