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.

Compliance with QRD template v10.4

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.1Summary:

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

AdoptedReference 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

• 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 30

• Guideline on Nordic packages - Questions and answers
• List of standard terms for pharmaceutical dosage forms, routes of administration and containers
• Interinstitutional style guide
• Guideline on summary of product characteristics revision 2
• Guideline on the packaging information of medicinal products for human use authorised by the Community
• Guideline on the readability of the labelling and package leaflet of medicinal product for human use (incl. Braille requirements, see Chapter 2)
• Medical Dictionary for Regulatory Activities (MedDRA)