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 human 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
Lessons learned from the review of the labelling of centrally authorised pandemic vaccines (English only) adopted 20/02/2014 28/01/2016  
Acceptability of IU as abbreviation for International Units in the strength of human medicinal products (English only)   18/11/2013    
List of official languages per country (English only)   04/04/2012 22/11/2013  
Abbreviation of names of days on calendarised blisters (English only)   04/04/2012    
Draft Quality Review of Documents recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products (English only) draft: consultation closed 01/04/2011    
Tables of non-standard abbreviations to be used in the summary of product characteristics (English only)   01/04/2009 26/06/2012  
Compilation of Quality Review of Documents decisions on stylistic matters in product information (English only)   01/02/2008 10/06/2015  
Compilation of Quality Review of Documents decisions on the use of terms (English only)   01/12/2005 28/03/2011  
Names of the European Union / European Economic Area countries (English only)   23/07/2008 08/04/2015  
Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates (English only) adopted 01/06/2007 15/04/2011 01/06/2007
Addressing the paediatric or incapacitated patient in the package leaflet (English only)   09/03/2000    
Quality Review of Documents recommendations on the expression of strength in the name of centrally authorised human medicinal products (as stated in section 1 of the summary of product characteristics, and in the name section of labelling and the package leaflet) (English only) adopted 18/11/2009   01/03/2010
Quality Review of Documents (QRD) form for submission and assessment of user testing bridging proposals (English only)   22/12/2014 09/07/2015  
Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal products (English only)   24/07/2015    
Request/declaration form for the provision of information via quick response (QR) codes in the centralised procedure (English only)   24/07/2015    
Member States contact points for review of national versions of quick response (QR) codes (English only)   24/07/2015 15/10/2015  

Committee for Medicinal Products for Human Use (CHMP) scientific guidelines

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Other guidelines

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Reference information

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