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. 

• 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