The European Medicines Agency has updated its veterinary product information template to support the implementation of the new Veterinary Medicinal Products Regulation which became applicable on 28th January 2022. In this article, we discuss what changes have been made, what triggered them, and what they mean for applicants and marketing authorisation holders of veterinary medicinal products.
The European Medicines Agency (EMA) provides templates to help applicants and marketing authorisation holders (MAHs) draw up the product information for their veterinary medicines. The product information is a set of documents consisting of the summary of product characteristics (SPC), labelling, and package leaflet. It contains officially approved information intended for healthcare professionals, farmers, or animal owners. The veterinary product information template defines the format and layout of the product information, and contains the standard headings, as well as the most commonly used standard statements and terms. The template is available in all 24 official European Union (EU) languages plus Icelandic and Norwegian, and is regularly reviewed and updated by EMA’s Working Group on Quality Review of Documents (QRD).
Why did the veterinary product information template need updating?
The veterinary product information template was updated in response to new Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) that came into effect on 28th January 2019 and, after a three-year transition period, became applicable in all EU Member States from 28th January 2022. The new legislation represents a substantial change in how veterinary medicinal products are authorised, monitored, and controlled in the EU. This new EU legal framework necessitated certain changes to what should be included in the product information. Consequently, version 9 of the veterinary product information template was published on 18th October 2021 in all 24 EU languages plus Icelandic and Norwegian. Also in October 2021, EMA made some minor editorial changes and corrections to the English version, which did not affect the other language versions.
What does the new veterinary product information template contain?
The QRD veterinary product information template version 9.0 contains:
- A new structure of the SPC, labelling, and package leaflet with the order of sections in the package leaflet aligned with those in the SPC.
- Simplified sections on ‘frequency and seriousness of adverse events’.
- Information that previously appeared in the labelling and is now included only in the package leaflet. The aim is to simplify the outer and immediate labelling. A reference to the package leaflet is made in places where information has been removed.
- A consolidated section for ‘minimum particulars to appear on small immediate packaging units’, which now includes blisters and strips.
- A new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products. This is to promote prudent use of such products and help minimise the risk of development of antimicrobial resistance.
- Expanded guidance text in many sections to clarify what information exactly should be included in those sections (e.g. environmental properties as opposed to special precautions for the environment, and date of last revision).
- Standard statements for marketing authorisations granted for limited markets and under exceptional circumstances.
- Reference to national collection systems for the disposal of unused veterinary medicinal products or waste materials derived from them. This is to reflect the legal requirements under Regulation (EU) 2019/6.
- Guidance on specific content for novel therapy veterinary medicinal products.
- More flexibility in some sections, e.g. the expiry date can be expressed as dd/mm/yyyy for certain novel therapy and biological veterinary medicinal products.
- Consolidated section for all contact details.
Which version of the veterinary product information template should applicants use?
EMA advises that applicants should use QRD veterinary product information template version 9.0 dated October 2021 for all initial marketing authorisation applications validated on or after 28th January 2022. For presenting the product information in marketing authorisation applications and post-authorisation applications that were validated before 28th January 2022, applicants should continue to use QRD veterinary product information template version 8.2 dated January 2021. In due course, EMA will provide further information on how and when MAHs should submit a variation to align their product information with QRD veterinary product information template version 9.0.
Does the product information now also need to be available in Irish?
On 1st January 2022, after three successive five-year periods of derogation, Irish became a full official and working language of the EU, enjoying the same status as the 23 other official EU languages. In practice, this means that decisions of the European Commission addressed to EU Member States, including the product information they contain, need to be translated into Irish together with the other official EU languages for veterinary referral procedures. Irish is also now the authentic language of Commission’s decisions addressed to any MAH established in Ireland, unless they request a language waiver. Because the EU Treaties do not list official or working EU languages, but rather indicate which language versions of the Treaties are considered original and authentic, the term ‘authentic language’ is used for the languages in which texts are considered by the EU as authentic and as such carrying authoritative force. MAHs 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 can be requested using the Irish language waiver request template. Once the waiver is granted, it will apply to all marketing authorisations held by the recipient. Further information and advice is available in the Guidance on Irish language derogation ending on 1st January 2022.
Will there be more updates to other QRD templates related to veterinary medicinal products?
As a next step, EMA will finalise the combined label and package leaflet template in the fourth quarter of 2021. This combined label and package leaflet template is intended for use when there is no package leaflet provided with the veterinary medicinal product, and all information that would have otherwise been included in it, appears instead on the immediate packaging. The combined template has been in use as part of a pilot project since 2018, and is available in all EU languages (with the exception of Irish) as well as in Icelandic and Norwegian as the Particulars to appear on the immediate packaging – combined label and package leaflet template.
You can download the English version of QRD veterinary product information template version 9.0 and its other 25 language versions below.
Please note that the information contained in this article is provided for guidance only, and any specific advice should be sought from a competent regulatory expert. If you have any questions related to the translation of your veterinary medicinal product information, please write them in the comments box below, or contact us directly.