Veterinary product information templates

The European Medicines Agency's (EMA) provides templates for product information for use by applicants and marketing authorisation holders of veterinary medicines. EMA'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 applicable requirements.

Applicants should use:

Current template (v.9)

Product information template v.9 supports the requirements of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which applies from 28 January 2022.

Template v.9 contains:

  • a new structure of the SPClabelling and package leaflet with the order of sections in the package leafet and in the SPC aligned as far as possible;
  • information only to be included in the package leaflet that was formerly in the labelling, to simplify the outer and immediate labelling and emphasise the importance of reading the package leaflet;
  • a consolidated section on ‘minimum particulars to appear on small immediate packaging units' which now incorporates blisters and strips. This does not contain any mandatory information requiring translation;
  • a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines, to promote prudent use of antimcobials and limit the risk of development of antimicrobial resistance. This includes restrictions on conditions of use that are not in accordance with the terms of the marketing authorisation, i.e. restrictions on conditions for the so-called ‘cascade’ use of certain veterinary medicines;
  • expanded guidance text in many sections to improve clarity for applicants and regulators (e.g. environmental properties versus special precautions for the environment and section on date of revision);
  • standard text for marketing authorisations granted for veterinary limited markets and under exceptional circumstances
  • reference to national collection systems for disposal of waste veterinary medicines. This aims to help with correct disposal of unused or waste veterinary medicines, to reflect legal requirements under Regulation (EU) 2019/6;
  • guidance on specific content for novel therapies;
  • increased flexibility in some sections, e.g. possibility to express expiry date as dd/mm/yyyy for certain novel therapy and biological veterinary medicinal products;
  • consolidated section for all contact details.

EMA also simplified the SPC and package leaflet sections on 'frequency and seriousness of adverse events', based on advice from the CVMP's Pharmacovigilance Working Party

EMA's Working Group on Quality Review of Documents (QRD), the CMDv and CVMP agreed the final template following a public consultation.

The template is available in all EU languages, as of October 2021. EMA also made some editorial changes and corrections in the English version in October 2021. 

Previous template (v.8.2)

Applicants have to continue to use template v.8.2 for presenting the product information in marketing authorisation applications and post-authorisation applications that were validated before 28 January 2022. For further information on the transitional regime for existing marketing authorisations, please refer to the statement of DG SANTE on Article 152(2) of Regulation (EU) 2019/6

EMA and the Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv) will provide further information on how and when marketing authorisation holders should submit a variation to align their product information with QRD template v.9 as part of their future guidance on classifications of variations requiring assessment (classification G.I.18).

QRD template v.8.2 has been revised in December 2021 to specify Northern Ireland in the list of local representatives at the end of the package leaflet.

  • List item

    QRD veterinary product-information template version 8.2 (DOC/176 KB)


    First published: 08/04/2010
    Last updated: 31/12/2020
    Version 8.2

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    QRD veterinary product-information annotated template (English) version 8.2 (PDF/473.68 KB)


    First published: 08/04/2010
    Last updated: 21/12/2020

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    QRD veterinary annex A template (DOCX/17.53 KB)


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

QRD combined label-leaflet template (v.9.0)

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    QRD combined label-leaflet template v.9.0 (DOCX/52.96 KB)


    First published: 03/04/2017
    Last updated: 12/04/2022

  • List item

    QRD combined label-leaflet annotated template (English) v.9.0 (PDF/379.8 KB)


    First published: 12/04/2022


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