Veterinary product information templates

This page lists the templates for product information for use by applicants and marketing authorisation holders of veterinary medicines. The European Medicines Agency's (EMA) 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.

QRD template v8.2 is revised to specify Northern Ireland in the list of local representatives at the end of the package leaflet.

As of 1 January 2021, any new marketing authorisation application submitted via the centralised procedure must comply with the revised QRD template v8.2 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 procedure affecting the product information annexes before 31 December 2021 must submit a type IA variation (C.II.6.a) to comply with the revised QRD template.

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Consultation on future product information template

A new product information template is available in draft for public consultation, intended to take account of the requirements of the Veterinary Medicines Regulation (Regulation (EU) 2019/6)

EMA and the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) will inform marketing authorisation applicants and holders when to start using the new template, after Regulation (EU) 2019/6 enters into force in January 2022. 

The new template contains:

  • a new structure of the SPC and package leaflet;
  • 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;
  • a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines, to limit the risk of development of Antimicrobial resistance;
  • 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;
  • guidance on specific content for novel therapies.

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, and aligned the sequence of package leaflet sections with the SPC as far as possible. 

The template contains a high-level cross-reference to all relevant guidance and legislation (see lines 39-41) rather than references to specific guidance in different sections, as some legal acts and guidance are under development.

EMA is not publishing the new template with tracked changes as these would be visually difficult to read and it is simpler to compare the clean text with the current template. 

Stakeholders should send any comments on the draft template to qrd@ema.europa.eu by 14 May 2021 using the form available below or via a link in the template. 

EMA's Working Group on Quality Review of Documents (QRD), the CMDv and CVMP agreed the draft template before publication. 

Templates

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