What is the EU QRD template, and does it fix the wording of product information?
The QRD template is the European Medicines Agency's model for product information: the summary of product characteristics, labelling and package leaflet. EMA says its guidance sets the content, standard headings, and the most common standard statements and terms in all official EU languages plus Icelandic and Norwegian, along with format and layout. It fixes the structure and the stock phrases. The product-specific text is still written by the company.
This page is general information, not legal or regulatory advice.
Who makes it and what it covers
EMA's Working Group on Quality Review of Documents (QRD) develops and updates the templates for applicants and marketing authorisation holders. EMA notes the templates are non-exhaustive and that it's the company's responsibility to make sure its product information meets all the requirements.
What it fixes and what it doesn't
- Fixed: standard headings, format and layout, and the most common standard statements and terms, in all official EU languages.
- Not fixed: the product-specific sentences under those headings, such as the warnings, dosing and side-effect text for that medicine.
Our view: a correctly spelled wrong word is unlikely to sit in a standard statement copied correctly from the template, but it can sit in the product-specific text around it, in any language version.
EMA consulted on a revised template
The current template is version 10.4. EMA held a public consultation on a draft version 11 from 14 April to 31 August 2025, mainly to make the package leaflet more understandable and relevant to patients. Proposals include shortening the leaflet, new standard statements and reorganising warnings into a more logical order. The consultation has closed, and EMA's page still lists version 11 as a draft and describes the revision as ongoing.
The US comparison
Our view: the closest US parallel is the fixed Drug Facts headings for OTC labels. See what rules govern the exact wording on a drug label.
Sources
Last reviewed: October 14, 2026
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FAQ
What is the QRD template?
EMA's model for EU product information, setting content, standard headings, common standard statements and terms in all official EU languages, and format and layout.
Does the QRD template fix all the wording?
No. It fixes headings, layout and standard statements. The product-specific text under those headings is written by the company.
Who is responsible for EU product information complying with the rules?
EMA says it's the company's responsibility to ensure the product information complies with all requirements.