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.

Veterinary product information templates (updated)

The QRD group, the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) and the Committee for Medicinal Products for Veterinary Use (CVMP) revised the veterinary product information templates in February 2017. This revision builds on 4 years of experience with the previous version 8.

The QRD group also implemented editorial improvements in the translations.

EMA published an implementation plan for the centralised procedure and the CMDv published an implementation plan for the decentrealised, the mutual recognition and national procedures on their respective websites. 

The revised templates are available on both the EMA and CMDv websites. 

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 8.1 - clean (English only)   2012-10-26 2017-02-15  
Quality Review of Documents veterinary product-information annotated template (English) version 8.1 - highlighted (English only)   2008-12-19 2017-02-15  
Implementation plan (veterinary) (English only)   2012-10-26 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 BG = bălgarski   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 ES = español   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 CS = čeština   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 DA = dansk   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 DE = Deutsch   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 ET = eesti keel   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 EL = elliniká   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 EN = English   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 FR = français   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 IT = italiano   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 LV = latviešu valoda   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 LT = lietuvių kalba   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 HU = magyar   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 MT = Malti   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 NL = Nederlands   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 PL = polski   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 PT = português   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 RO = română   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 SK = slovenčina   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 SL = slovenščina   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 FI = suomi   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 SV = svenska   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 HR = Hrvatski   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 IS = Islenska   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 NO = Norsk   2010-04-08 2017-02-15  
Quality Review of Documents veterinary product-information template version 8.1 - highlighted BG = bălgarski   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted ES = español   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted CS = čeština   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted DA = dansk   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted DE = Deutsch   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted ET = eesti keel   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted EL = elliniká   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted EN = English   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted FR = français   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted IT = italiano   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted LV = latviešu valoda   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted LT = lietuvių kalba   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted HU = magyar   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted MT = Malti   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted NL = Nederlands   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted PL = polski   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted PT = português   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted RO = română   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted SK = slovenčina   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted SL = slovenščina   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted FI = suomi   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted SV = svenska   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted HR = Hrvatski   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted IS = Islenska   2017-02-15    
Quality Review of Documents veterinary product-information template version 8.1 - highlighted NO = Norsk   2017-02-15    
Quality Review of Documents veterinary annex-A template BG = bălgarski   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template ES = español   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template CS = čeština   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template DA = dansk   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template DE = Deutsch   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template ET = eesti keel   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template EL = elliniká   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template EN = English   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template FR = français   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template IT = italiano   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template LV = latviešu valoda   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template LT = lietuvių kalba   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template HU = magyar   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template MT = Malti   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template NL = Nederlands   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template PL = polski   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template PT = português   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template RO = română   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template SK = slovenčina   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template SL = slovenščina   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template FI = suomi   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template SV = svenska   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template HR = Hrvatski   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template IS = Islenska   2009-06-19 2014-01-24  
Quality Review of Documents veterinary annex-A template NO = Norsk   2009-06-19 2014-01-24  

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)   2014-08-01