The European Medicines Agency (EMA) has published version 9.1 of the QRD veterinary combined label-leaflet template, updating the standardised format for veterinary medicinal product information. The revision, released on 5 May 2026, introduces minor technical adjustments to align with current regulatory requirements and improve clarity for manufacturers and end-users.
The QRD (Quality Review of Documents) template serves as the mandatory blueprint for the labelling and package leaflet of veterinary medicines authorised in the EU. Version 9.1 replaces the previous v.9.0 and incorporates feedback from stakeholders, including national competent authorities and industry associations. The changes are limited to formatting and wording refinements; no substantive policy shifts or new safety information requirements have been introduced.
Document scope and impact
The template applies to all veterinary medicinal products seeking EU-wide marketing authorisation via the centralised procedure. It covers the combined label and leaflet layout, including sections on product name, active substances, target species, dosage, withdrawal periods, and storage conditions. The update ensures consistency with the latest legal texts and pharmacovigilance obligations.
Stakeholder implications - Marketing authorisation holders: must adopt the new template for new applications and, where required, for existing products during renewal or variation procedures. The administrative burden is low as changes are primarily cosmetic. - National competent authorities: will reference v.9.1 when reviewing product information, ensuring harmonised assessment across Member States. - Veterinary professionals and animal owners: benefit from clearer, more readable leaflets, though the practical impact is marginal. - EU regulatory bodies: EMA and the European Commission gain improved standardisation, facilitating faster approval processes.
Next steps EMA expects applicants to use v.9.1 immediately for new submissions. The agency will provide a transition period for existing products, with detailed guidance to follow in a separate Q&A document. No further revisions are anticipated in the near term.
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