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. 

Reference documents

Questions and answers on labelling flexibilities for COVID-19 vaccines

Reference Number: EMA/726359/2022

Compilation of quality review of documents (QRD) on stylistic matters in product information

Reference Number: EMA/25090/2002 Rev. 23

Member states contact points for review of national versions of the content of mobile scanning and other technologies

Reference Number: EMA/358267/2015 Rev. 10

List of official languages per country

Reference Number: EMA/315185/2010 Rev.3

Request/declaration form for the provision of information via mobile scanning and other technologies in the centralised procedure

Reference Number: EMA/493921/2015 Rev.1Summary:

Request/declaration form

Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products

Reference Number: EMA/493897/2015 Rev. 1Summary:

General principles of acceptability and rules of procedure

Lessons learned from the review of the labelling of centrally authorised pandemic vaccines

Consultation dates: 20/02/2014 to 20/05/2014AdoptedReference Number: EMA/467700/2014

Quality Review of Documents (QRD) form for submission and assessment of user testing bridging proposals

Reference Number: EMA/355722/2014 Rev. 1

Names of the European Union / European Economic Area countries

Reference Number: EMA/123695/2004 Rev.13

Acceptability of IU as abbreviation for International Units in the strength of human medicinal products

Reference Number: EMA/704692/2012 Rev.2

Quality Review of Documents recommendations on the expression of strength in the name of centrally authorised human medicinal products

AdoptedLegal effective date: 01/03/2010Reference Number: EMA/707229/2009

Tables of non-standard abbreviations to be used in the summary of product characteristics

Reference Number: EMA/27236/2003 Rev. 14

Abbreviation of names of days on calendarised blisters

Reference Number: EMA/188814/2012

Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates

AdoptedLegal effective date: 01/06/2007Reference Number: EMA/62470/2007

Draft Quality Review of Documents recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products

Consultation dates: 01/04/2011 to 30/06/2011Draft: consultation closedReference Number: EMA/275297/2010

Compilation of Quality Review of Documents decisions on the use of terms

Addressing the paediatric or incapacitated patient in the package leaflet

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

Guideline on declaration of storage conditions

AdoptedLegal effective date: 01/10/2003Reference Number: CPMP/QWP/609/96/Rev 2

E 11: Clinical investigation of medicinal products in the paediatric population - Step 5

AdoptedLegal effective date: 01/01/2001Reference Number: CPMP/ICH/2711/99

Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution

AdoptedLegal effective date: 01/07/1998Reference Number: CPMP/QWP/159/96

Other guidelines

Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

Reference Number: EMA/627621/2011 Rev. 1Summary:

This document outlines the general principles to follow for the preparation of the summary of product characteristics (SmPC) for a generic, hybrid or biosimilar medicinal product to be authorised via the centralised procedure using a reference medicinal product authorised either at national level or centrally.

Operational procedure on handling of consultation with target patient groups on package leaflets for centrally authorised products for human use

Reference Number: 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