Product-information (QRD) templates - Human

The European Medicines Agency's (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human medicines.

The information contained in these documents is non-exhaustive.

Companies should refer to all relevant European Union legislation and guidelines when drawing up applications.

It is the company's responsibility to ensure that the product information complies with all such requirements.

For more on product information requirements, see:

• Product-information requirements

QRD template version 11

Version 11 of the quality review of documents (QRD) template was available for public consultation. 

EMA is revising the QRD template for centrally authorised medicines for human use mainly to improve the content and structure of their package leaflet.  

This aims to make the package leaflet more understandable and relevant to patients, while complying with the current legislative framework, Directive 2001/83/EC.

Main proposed changes include:

•    Deleting or making certain text optional to shorten the leaflet
•    Creating standard statements to improve patient-friendliness and consistency across products
•    Relocating important information at the beginning of the leaflet
•    Clustering information by subject to make it easier to locate
•    Reorganising warnings / precautions in a more logical order

Stakeholders invited to comment on the draft QRD template v11 included the pharmaceutical industry, national competent authorities, patients, healthcare professionals and academia.

Find below the draft template, in both clean and track change versions.

Quality Review of Documents (QRD) annotated template v11: Draft for public consultation

Draft: consultation closed Consultation dates: 14/04/2025 to 31/08/2025 Summary:

The ongoing revision of the QRD template started in September 2023, mainly triggered by the Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. This report is an assessment of shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL), and it provides some recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.

In addition, the revision has also considered the extensive experience gained over the years by the EMA Labelling Office and the QRD members, the voice of patients, consumers and healthcare professionals, the feedback provided by stakeholders performing consultation with target patients’ groups (so called user testing), and the work performed by some industry stakeholders on the improvement of the PL.

Quality Review of Documents (QRD) annotated template v11: Draft for public consultation - tracked changes

Summary:

The main changes in the QRD template intend to tackle the following aspects:
• The recurrent issue of the length of the PL, hence the deletion of the introductory bullets and the optionality of the table of contents.
• The creation of new standard statements aimed at improving patient-friendliness as well as consistency across products. 
• The relocation of some information that is deemed important enough to appear at the beginning of the leaflet.
• The grouping of information by subject, as patients tend to look for information related to the same topic in the same place (e.g. interactions with food and drink merged with instructions on taking the medicine with food and drink).
• The reorganisation of warnings and precautions throughout the PL so that they follow the logics of what is important before, while, and after taking the medicine.
• The inclusion of a new optional section 7 for instructions for use when these are too extensive to be accommodated in section 3 or if they are related to a medical device accompanying the medicine.

Package leaflet key information

EMA enabled stakeholders to comment on a public consultation on the potential inclusion of a ‘key information section’ in the package leaflet of centrally authorised medicines.

A ‘key information section’ section would allow patients and healthcare professionals, among others, to:

• rapidly identify key safety messages;
• and find information on the benefit-risk profile of medicines.

The public consultation concluded on 31 May 2025.

Key information section in package leaflet of centrally authorised medicinal products: Public consultation

Draft: consultation closed Consultation dates: 14/04/2025 to 31/05/2025 Summary:

The European Medicines Agency (EMA) and the Quality Review of Documents (QRD) Working Group are currently working on the revision of the QRD template for centrally authorised medicinal products for human use, with the aim of improving the content and structure of the package leaflet and making it more understandable and relevant to patients, while still complying with the current legislative framework. The draft revised QRD template has been released for public consultation until 31 August 2025. 

Separate from the public consultation of the QRD template, EMA would like to gather the views of stakeholders on the potential usefulness and added value of a new “key information section” in the package leaflet. The addition of this new section addresses one of the recommendations in the Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and it would allow patients, users and healthcare professionals to rapidly identify key safety messages, balanced with information on the benefit-risk profile of the medicine.

As concluded in the report, the evidence and views collected may help inform the decision on whether such a key information section in the package leaflet is needed and, if so, what type of information should be provided therein.

EMA would like to invite all interested stakeholders to respond to the following survey by 31 May 2025: EU Survey: Potential inclusion of key information section in package leaflet of centrally authorised medicines - public consultation.

More information is available: Product-information (QRD) templates - Human.

Compliance with QRD template version 10.4

The QRD template v10.4 was revised to delete 'United Kingdom (Northern Ireland)' from the list of local representatives in the package leaflet to comply with the Windsor Framework for labelling and packaging of medicines. 

In addition, EMA has implemented the following minor changes: 

• replacing hyperlinks from EMA's previous website;
• correcting details in the list of local representatives for Denmark, in all available language versions, for both QRD and ATMP templates;
• making linguistic amendments to the Norwegian version of the ATMP template;
• replacing the hyperlinks for the mutual recognition procedure, decentralised procedure and referral templates, in all available language versions.

For the implementation of the QRD template v10.4, please refer to the guidance below which includes questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use (questions 5 and 9):

Questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use

Reference Number: EMA/581345/2023 Rev. 2

Centralised procedures - Quality Review of Documents (QRD) templates

QRD product-information annotated template (English) version 10.4

Reference Number: 10.4

QRD product-information annotated template (English) version 10.4 - highlighted

Reference Number: 10.4

QRD product-information template version 10.4

Reference Number: 10.4

QRD product-information template version 10.4 - highlighted

Reference Number: 10.4

QRD annex A template

QRD annex related to the Article-127a template

QRD annex IV conditional positive template

QRD annex IV exceptional circumstances positive template

QRD annex IV standard positive template

QRD PSUR annex IV template

Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use

Reference Number: EMA/785582/2014 rev.1 Summary:

Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features.

Policy on combined Summaries of Product Characteristics (SmPCs)

Reference Number: EMA/333423/2015

Core SmPC, labelling and package leaflet for ATMPs containing genetically modified cells

Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells

Adopted Reference Number: EMA/CAT/CHMP/158266/2021

Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells highlighted

ATMP product information template version 1.1

ATMP product information template version 1.1 - highlighted

Mutual-recognition, decentralised, referral and PSUR single assessment (PSUSA) (Nationally Authorised Products only) procedures

Mutual-recognition decentralised referral product information template (English) version 4.2

Mutual-recognition, decentralised and referral product-information template version 4.2

PSUSA nationally authorised products template

For more information, see:

• Committee for Mutual Recognition and Decentralised Procedures - Human: Annotated Quality Review of Documents template for mutual-recognition and decentralised procedures and specific addendum for (traditional) herbal medicinal products
• Practical information on translations for referral procedures (human)

Appendices

QRD Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics (Cover page)

Reference Number: EMA/215345/2023

QRD Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics

QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics (Cover page)

Reference Number: EMA/295934/2018 v.6

QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics

QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page)

Reference Number: EMEA/29277/2003 v.5

QRD Appendix III to the Quality Review of Documents templates for human medicinal products

QRD Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products

Reference Number: EMA/286379/2019 Rev.14

QRD Appendix V - Adverse-drug-reaction reporting details

Reference Number: EMA/67830/2013 Version 33