Veterinary product information templates
VeterinaryRegulatory and procedural guidance
The European Medicines Agency's (EMA) provides templates for product information for use by applicants and marketing authorisation holders of veterinary medicines. EMA's 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.
Applicants should use:
- Template v.8.2 for applications (initial and post-authorisation) validated before 28 January 2022;
- Template v.9 for initial marketing authorisation applications validated on or after 28 January 2022.
- Combined label-leaflet v.9.0 for when there is no package leaflet and all information is then required to appear on the outer packaging (Art. 14(4) of Regulation (EU) 2019/6
Current template (v.9)
Product information template v.9 supports the requirements of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which applies from 28 January 2022.
Template v.9 contains:
- a new structure of the SPC, labelling and package leaflet with the order of sections in the package leaflet and in the SPC aligned as far as possible;
- 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. This does not contain any mandatory information requiring translation;
- a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines, to promote prudent use of antimicrobials and limit the risk of development of antimicrobial resistance. This includes restrictions on conditions of use that are not in accordance with the terms of the marketing authorisation, i.e. restrictions on conditions for the so-called ‘cascade’ use of certain veterinary medicines;
- expanded guidance text in many sections to improve clarity for applicants and regulators (e.g. environmental properties versus special precautions for the environment and section on date of revision);
- 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. This aims to help with correct disposal of unused or waste veterinary medicines, to reflect legal requirements under Regulation (EU) 2019/6;
- guidance on specific content for novel therapies;
- increased flexibility in some sections, e.g. possibility to express expiry date as dd/mm/yyyy for certain novel therapy and biological veterinary medicinal products;
- consolidated section for all contact details.
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.
EMA's Working Group on Quality Review of Documents (QRD), the CVMP and the Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv) agreed the final template following a public consultation.
The template is available in all EU languages. EMA also made some editorial changes and corrections in the English version as well as all EU languages in November 2022.
Previous template (v.8.2)
Applicants can continue to use template v.8.2 for presenting the product information in marketing authorisation applications and post-authorisation applications that were validated before 28 January 2022.
A transition period was introduced by Regulation (EU) 2022/839.
QRD template v.8.2 was revised in December 2021 to specify Northern Ireland in the list of local representatives at the end of the package leaflet.
Marketing authorisation holders should update and implement their product information, in line QRD template v.9, by 29 January 2027.
They should do so by submitting a variation requiring assessment of classification G.I.18, in line with the CMDv / EMA guidance listed below: