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 v10.2 rev.1

QRD template v10.2 was revised on 1/01/2021 solely to specify Northern Ireland in the list of local representatives at the end of the package leaflet.

QRD template v10.2 rev.1 has been revised solely to amend the statement for conditional marketing authorisations in Annex II.

As of 1 January 2021, any new marketing authorisation application granted via the centralised procedure must comply with the revised QRD template v10.2 rev.1. Ongoing  marketing authorisation applications must align their product information to the revised QRD template v10.2 rev.1 as early as possible, and by Day 181 of the procedure at the latest.

Holders of existing marketing authorisations granted via the centralised procedure must update the product information annexes by 31 December 2021, in any regulatory procedure that affects these annexes, to comply with the revised QRD template.

Marketing authorisation holders for medicinal products with no regulatory procedures affecting the product information annexes before 31 December 2021 must submit a dedicated notification under Article 61(3) of Directive 2001/83/EC 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.

For ongoing applications, EMA encourages applicants to complete Annex II as per the revised QRD template when submitting their responses at Day 121 or Day 181 of the procedure, to facilitate the review process by EMA's scientific committees.

Additional linguistic corrections in the Swedish and Finnish language templates have been implemented.

• 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)