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 PDF icon Swedish and PDF icon Finnish language templates have been implemented.

Centralised procedures - Quality Review of Documents (QRD) templates

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    QRD product-information annotated template (English) version 10.2 Rev.1 (PDF/518.64 KB)


    First published: 03/12/1997
    Last updated: 09/02/2021
    10.2 Rev.1

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    QRD product-information annotated template (English) version 10.2 Rev.1 - highlighted (PDF/395.09 KB)


    First published: 03/12/1997
    Last updated: 09/02/2021
    10.2 Rev.1

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    QRD product-information template version 10.2 Rev.1 (DOCX/60.1 KB)


    First published: 03/12/1997
    Last updated: 08/02/2021
    10.2 Rev.1

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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
    10.1

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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 4.1 (DOCX/58.05 KB)


    First published: 30/08/2011
    Last updated: 17/02/2020

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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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