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 2014-02-20 2016-01-28  
Acceptability of IU as abbreviation for International Units in the strength of human medicinal products (English only)   2013-11-18    
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    
Draft Quality Review of Documents recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products (English only) draft: consultation closed 2011-04-01    
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
Addressing the paediatric or incapacitated patient in the package leaflet (English only)   2000-03-09    
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 2009-11-18   2010-03-01
Quality Review of Documents (QRD) form for submission and assessment of user testing bridging proposals (English only)   2014-12-22 2015-07-09  
Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal products (English only)   2015-07-24    
Request/declaration form for the provision of information via quick response (QR) codes in the centralised procedure (English only)   2015-07-24    
Member States contact points for review of national versions of quick response (QR) codes (English only)   2015-07-24 2015-10-15  

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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