Product-information templates

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 v10.1 (new)

As of 28 June 2019, any new marketing authorisations application submitted via the centralised procedure should comply with the revised QRD template v10.1 as early as possible and by Day 181 of the procedure the latest.          

EMA encourages holders of existing marketing authorisations granted by the centralised procedure to use the first upcoming regulatory procedure affecting the product information annexes (such as line extension, renewal, variation, etc.) to comply with the revised QRD template. Article 61(3) notifications and variations not affecting the product information annexes should not be used for this purpose.

Applicants should also note that from 28 June 2019 onwards they should 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 the marketing authorisation application. For ongoing applications, EMA encourages applicants to also complete Annex II as per the revised QRD template when submitting their responses at Day 121 or Day 181 of the procedure.  This aims to facilitate the review process by EMA's relevant scientific committees.

Mobile scanning and other technologies

Update: Applicants and marketing authorisation holders can request the inclusion of mobile scanning and other technologies (including quick response (QR) codes) in the context of an evaluation procedure, including:

  • as part of the initial marketing-authorisation application;
  • after the medicine is authorised via Article 61(3) with the rapporteur's involvement;
  • as part of other procedures affecting annexes.

They should request inclusion of these technologies by submitting the following form, along with all relevant information within module 1.3.1 of the dossier:

For guidance on submission requirements, general principles of acceptability and assessment of mobile scanning and other technology requests, see:

This guidance replaces EMA's guidance document on ‘Quick 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 mobile scanning and other technologies 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

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    QRD product-information annotated template (English) version 10.1 (PDF/237.82 KB)


    First published: 03/12/1997
    Last updated: 28/06/2019

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    QRD product-information annotated template (English) version 10.1 - highlighted (PDF/251.14 KB)


    First published: 03/12/1997
    Last updated: 28/06/2019

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    QRD product-information template version 10.1 (DOCX/86.79 KB)


    First published: 03/12/1997
    Last updated: 19/09/2019

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    QRD product-information template version 10.1 - highlighted (PDF/183.66 KB)


    First published: 28/06/2019
    Last updated: 19/09/2019

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    QRD annex A template (DOCX/33.89 KB)


    First published: 19/06/2009
    Last updated: 28/06/2019

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    QRD annex related to the Article-127a template (DOCX/19 KB)


    First published: 08/10/2012
    Last updated: 28/06/2019

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    QRD annex IV conditional positive template (DOCX/14.86 KB)


    First published: 08/10/2012
    Last updated: 28/06/2019

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    QRD annex IV exceptional circumstances positive template (DOCX/14.81 KB)


    First published: 08/10/2012
    Last updated: 28/06/2019

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    QRD annex IV standard positive template (DOCX/21.17 KB)


    First published: 08/10/2012
    Last updated: 28/06/2019

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    QRD PSUR annex IV template (DOCX/21.39 KB)


    First published: 19/03/2014
    Last updated: 28/06/2019

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    Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use (PDF/57.88 KB)


    First published: 09/02/2016
    Last updated: 05/07/2017
    EMA/785582/2014 rev.1

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    Policy on combined Summaries of Product Characteristics (SmPCs) (PDF/84.35 KB)


    First published: 10/06/2015
    Last updated: 10/06/2015
    EMA/333423/2015

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

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    Mutual-recognition, decentralised and referral product-information template version 4 (DOC/141 KB)


    First published: 30/08/2011
    Last updated: 09/02/2016

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    PSUSA nationally authorised products template (DOCX/22.2 KB)


    First published: 15/09/2015
    Last updated: 28/06/2019

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