Product information: Reference documents and guidelines
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.
In light of the United Kingdom's (UK) withdrawal from the EU, several QRD reference documents are revised to reflect the provision that as of 1 January 2021, EU law applies in the UK only to the territory of Northern Ireland to the extent foreseen in the Protocol on Ireland / Northern Ireland. For more information see Brexit-related guidance for companies.
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Questions and answers on labelling flexibilities for COVID-19 vaccines (PDF/132.58 KB) (updated)
First published: 27/11/2020
Last updated: 12/09/2023
EMA/726359/2022 -
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Compilation of quality review of documents (QRD) on stylistic matters in product information (PDF/410.74 KB)
First published: 01/02/2008
Last updated: 09/06/2022
EMA/25090/2002 Rev. 22 -
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Member states contact points for review of national versions of the content of mobile scanning and other technologies (PDF/128.83 KB)
First published: 24/07/2015
Last updated: 18/08/2023
EMA/358267/2015 Rev.8 -
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List of official languages per country (PDF/124.9 KB)
First published: 04/04/2012
Last updated: 31/12/2020
EMA/315185/2010 Rev.3 -
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Request/declaration form for the provision of information via mobile scanning and other technologies in the centralised procedure (DOC/153 KB)
First published: 24/07/2015
Last updated: 07/12/2018
EMA/493921/2015 Rev.1 -
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Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products (PDF/166.79 KB)
First published: 24/07/2015
Last updated: 07/12/2018
EMA/493897/2015 Rev. 1 -
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Lessons learned from the review of the labelling of centrally authorised pandemic vaccines (PDF/125.61 KB)
Adopted
First published: 20/02/2014
Last updated: 28/01/2016
Consultation dates: 20/02/2014 to 20/05/2014
EMA/467700/2014 -
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Quality Review of Documents (QRD) form for submission and assessment of user testing bridging proposals (DOC/238 KB)
First published: 22/12/2014
Last updated: 09/07/2015
EMA/355722/2014 Rev. 1 -
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Names of the European Union / European Economic Area countries (PDF/286.77 KB)
First published: 23/07/2008
Last updated: 08/12/2021
EMA/123695/2004 Rev.13 -
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Acceptability of IU as abbreviation for International Units in the strength of human medicinal products (PDF/163.29 KB)
First published: 18/11/2013
Last updated: 24/03/2023
EMA/704692/2012 Rev.2 -
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Quality Review of Documents recommendations on the expression of strength in the name of centrally authorised human medicinal products (PDF/74.39 KB)
Adopted
First published: 18/11/2009
Last updated: 18/11/2009
Legal effective date: 01/03/2010
EMA/707229/2009 -
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Tables of non-standard abbreviations to be used in the summary of product characteristics (PDF/268.34 KB)
First published: 01/04/2009
Last updated: 08/12/2021
EMA/27236/2003 Rev. 14 -
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Abbreviation of names of days on calendarised blisters (PDF/194.95 KB)
First published: 04/04/2012
Last updated: 31/12/2020
EMA/188814/2012 -
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Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates (PDF/92.33 KB)
Adopted
First published: 01/06/2007
Last updated: 15/04/2011
Legal effective date: 01/06/2007
EMA/62470/2007 -
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Draft Quality Review of Documents recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products (PDF/144.01 KB)
Draft: consultation closed
First published: 02/04/2011
Last updated: 02/04/2011
Consultation dates: 01/04/2011 to 30/06/2011
EMA/275297/2010 -
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Compilation of Quality Review of Documents decisions on the use of terms (PDF/152.97 KB)
First published: 01/12/2005
Last updated: 28/03/2011 -
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Addressing the paediatric or incapacitated patient in the package leaflet (PDF/27.97 KB)
First published: 10/03/2000
Last updated: 10/03/2000
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Guideline on declaration of storage conditions (PDF/52.15 KB)
Adopted
First published: 19/11/2007
Last updated: 19/11/2007
Legal effective date: 01/10/2003
CPMP/QWP/609/96/Rev 2 -
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E 11: Clinical investigation of medicinal products in the paediatric population - Step 5 (PDF/156.9 KB)
Adopted
First published: 01/01/2001
Last updated: 01/01/2001
Legal effective date: 01/01/2001
CPMP/ICH/2711/99 -
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Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution (PDF/30.01 KB)
Adopted
First published: 28/01/1998
Last updated: 28/01/1998
Legal effective date: 01/07/1998
CPMP/QWP/159/96
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Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product (PDF/55.91 KB)
First published: 24/05/2012
Last updated: 27/06/2018
EMA/627621/2011 Rev. 1 -
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Operational procedure on handling of consultation with target patient groups on package leaflets for centrally authorised products for human use (PDF/221.76 KB)
First published: 20/10/2005
Last updated: 20/10/2005
EMEA/277378/2005
- Guideline on summary of product characteristics
- Guideline on the packaging information of medicinal products for human use authorised by the Union
- Guideline on the readability of the labelling and package leaflet of medicinal products for human use (incl. Braille requirements, see Chapter 2)
- Office for Official Publications of the European Communities
- EudraLex
- Volume 1: Pharmaceutical legislation: Medicinal products for human use
- Volume 2A: Procedures for marketing authorisation
- Volume 2B: Presentation and content of the dossier
- Volume 2C: Regulatory guidelines
- Volume 4: Good manufacturing practice (GMP) guidelines
- Volume 9 : Pharmacovigilance guidelines
- Scientific guidelines: Quality
- Scientific guidelines: Biologicals
- Scientific guidelines: Non-clinical
- Scientific guidelines: Clinical efficacy and safety
- Scientific guidelines: Multidisciplinary