Product-information 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 v10.3

QRD template v10.3 has been revised in September 2022 solely* to include guidance in Annex II section C for conditional marketing authorisations.

Any new marketing authorisation granted via the centralised procedure as a conditional marketing authorisation must comply with the revised QRD template v10.3. Ongoing marketing authorisation applications must align their product information to the revised QRD template v10.3 as early as possible, and by Day 181 of the procedure at the latest.

Holders of existing conditional marketing authorisations granted via the centralised procedure must update the product information annexes with the next regulatory procedure affecting the product information, and at the latest with the annual renewal, to comply with the revised QRD template.

Since 28 June 2019, applicants need to complete Annex II and present a draft of this together with the summary of product characteristics (SmPC), labelling and package leaflet when submitting the product information annexes as part of their marketing authorisation application.

*Additional linguistic corrections in the Czech, Danish, German, Estonian, Hungarian, Italian, Lithuanian and Slovenian language templates have been implemented.

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

This new guideline provides a template for ATMPs containing genetically modified cells which is made available in English and all the other EU languages.

Any new marketing authorisation granted via the centralised procedure for ATMPs containing genetically modified cells must comply with the guideline. Ongoing marketing authorisation applications must align their product information as early as possible, and by Day 181 of the procedure at the latest.

Holders of existing marketing authorisations granted via the centralised procedure for ATMPs containing genetically modified cells must update the product information annexes with the next regulatory procedure affecting the product information.

• 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)

• 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)