Product-information templates

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

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.

Quick response (QR) codes

A request for the inclusion of Quick Response (QR) codes can be made in the context of an evaluation procedure (as part of the initial marketing-authorisation application or after the medicine is authorised via Article 61(3) with the rapporteur's involvement or other procedure affecting annexes) by submitting the Microsoft Office document iconQR code request/declaration form along with all relevant information within module 1.3.1 of the dossier.

Guidance on submission requirements, general principles of acceptability and assessment of QR code requests is available in PDF iconQuick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal products .

A list of PDF iconnational contact points has been set up for the review of national versions of QR codes approved through the centralised procedure.

Information on doping

There is no direct legal requirement to include information on doping in sport in the product information of centrally authorised medicines. The Agency advises applicants not to include statements on doping.

However, the Agency acknowledges the public-health interest in accessing up-to-date information on substances that can be used in doping. This information is available on the website of the World Anti-Doping Agency (WADA), an independent international organisation created to promote, coordinate and monitor the fight against doping in sport in all its forms:

Centralised procedures - Quality Review of Documents (QRD) templates

Latest update: March 2018 - The QRD PSUR Annex IV template has been revised and republished in Croatian language only. No other languages have been affected.

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

The Agency does not publish English templates for annex A and annex I for referrals, because these annexes are prepared by the Agency. The translations of these annexes must be in line and consistent with the adopted English product information annexes of the product concerned.

Appendices

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