Product-information requirements for veterinary medicines
This section provides 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.
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:
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.