Product-information requirements for veterinary medicines

Information on the linguistic aspects of the product information for veterinary medicines, which includes the summary of product characteristics, labelling and package leaflet. It explains the content that should be included in these documents, as well as standard headings and the most commonly used standard statements and terms in all official European Union languages plus Icelandic and Norwegian, and defines the format and layout for the product information.

The European Medicines Agency has developed these templates and guidance to provide applicants with practical advice on how to draw up the product information. However, it provides these without prejudice to:

• any final positions from the Agency, the Committee for Medicinal Products for Veterinary Use (CVMP) or European institutions relating to the contents of the documents;
• the binding nature of the relevant legislation;
• any legal interpretations given by the European Commission or the Court of Justice of the European Union.

Also on this topic

• Veterinary product information templates
• Linguistic review - Veterinary
• Product information: Reference documents and guidelines

Irish language

From January 2022, a derogation expires concerning the status of Irish as a working language of the EU Institutions.  

This means that decisions of the European Commission addressed to EU Member States, including the product information they contain, will be translated into Irish together with the other official EU languages, for the following procedures:

• Veterinary referral procedures

Irish will also be the authentic language of Commission decisions addressed to any marketing authorisation holder established in Ireland, unless they request a language waiver using the template below.

Marketing authorisation holders established in Ireland should request a language waiver if they want English to be the authentic language of their product information and of decisions addressed to them by the European Commission. 

A language waiver will apply to all marketing authorisations held by the recipient. Further guidance and background information is available below. 

Guidance on Irish language derogation ending on 1 January 2022

Reference Number: EMA/699123/2021 Rev. 3

Irish language waiver request template

Mock-ups for veterinary medicines

Mock-ups should not be submitted to the Agency.

Marketing authorisation holders (MAHs) are responsible for the correct implementation of the agreed product information texts in their printed packaging materials, in line with the Commission Decision on the marketing authorisation and relevant EU legislation.

The same principle applies to specimens and samples.

More information:

• Regulation (EU) 2019/6

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2026.

See update history

5 March 2026

Section 'Mock-ups for veterinary medicines' added