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.

Centralised procedures - Quality Review of Documents (QRD) templates

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    QRD product-information annotated template (English) version 10.3 (PDF/766.95 KB)


    First published: 03/12/1997
    Last updated: 28/09/2022
    10.3

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    QRD product-information annotated template (English) version 10.3 - highlighted (PDF/768.17 KB)


    First published: 03/12/1997
    Last updated: 28/09/2022
    10.3

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    QRD product-information template version 10.3 (DOCX/69.1 KB)


    First published: 03/12/1997
    Last updated: 28/09/2022
    10.3

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    QRD product-information template version 10.3 - highlighted (PDF/569.36 KB)


    First published: 28/06/2019
    Last updated: 28/09/2022
    10.3

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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

Core SmPC, labelling and package leaflet for ATMPs containing genetically modified cells

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    Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (PDF/465.69 KB)

    Adopted

    First published: 26/10/2022
    EMA/CAT/CHMP/158266/2021

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    ATMP product information template version 1 (DOCX/75.47 KB)


    First published: 28/09/2022

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

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    Mutual-recognition decentralised referral product information template (English) version 4.2 (PDF/206.39 KB)


    First published: 28/04/2021

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    Mutual-recognition, decentralised and referral product-information template version 4.2 (DOCX/41.62 KB)


    First published: 30/08/2011
    Last updated: 26/04/2021

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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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