Veterinary Medicines Directorate
Mitigations for Veterinary Medicines Regulations
EU Regulation 2019/6 will apply in the EU from 28 January 2022. We played an active role in developing and negotiating the Regulation when we were part of the EU and therefore agree with much of its content.
The GB Veterinary Medicines Regulation (VMR) is under review and the formal public consultation has now closed .
Until such time that the revised GB VMR come into force, there will be what we call an airgap between both sets of legislation covering EU (NI) and GB.
We recognise that industry is set up to cover the region of Europe, which includes the UK, and its regulatory requirements. As an interim measure we have considered areas where we may bridge this gap between the EU Legislation and the current VMR, as they have an effect in GB, whilst still respecting both sets of legislation to reduce burdens to the industry and help facilitate the continued availability of veterinary medicines in NI and GB.
IMPORTANT: This is an interim measure and does not pre-empt or prejudice the outcome of the formal consultation on the GB VMR as we will take account of views from a wide range of stakeholders.
EU Regulation 2019/6
EU 2019/6 sets out revised requirements for the minimum information to appear on labelling of veterinary medicinal products, and places a greater emphasis on the use of a package leaflet for product information. The European Medicines Agency (EMA) have published a revised Summary of Product Characteristics (SPC) and QRD (labelling text) template (v.9) to be used for Marketing Authorisations validated on or after 28 January 2022 within the EU.
Applications validated on or after 28 January 2022
GB and NI-national only
For new GB and/or NI-national MA applications validated on or after the 28 January 2022, applicants are to use the which reflects the information required in the EU but also includes any missing national specific requirements as specified in the VMR.
Information that continues to be required under the VMR for GB-national MAs includes:
- Special warnings specified in the Marketing Authorisation and specific disposal advice on the outer packaging
- Reference to excipients on the outer and immediate packaging if knowledge of these is needed for safety reasons
An is available which provides supporting guidance on the information requirements listed.
NI-MRP or NI-Centralised
The EMAs revised Summary of Product Characteristics (SPC) and QRD (labelling text) template (v.9) is to be used for new NI MA applications validated on or after 28 January 2022 submitted with a NI-MRP or NI-Centralised scope. The new template provides a revised structure for the SPC and labelling, with an emphasis on the importance of reading the package leaflet. It also contains a new requirement to include information on special conditions for use (including restrictions on antimicrobial use) on the package leaflet.
Applications validated before 28 January 2022
Applications validated before 28 January 2022 will continue to use our if submitted on a national-only basis, or v8.2 of the EU template if submitted as part of a Mutual Recognition Procedure or a Centralised application involving other EU Member States.
Products authorised prior to 28 January 2022
Products authorised in NI and the EU prior to 28 January 2022 can continue to present product information using previous templates until January 2027. By this time, Marketing Authorisation Holders will need to have taken the necessary action to align with revised SPC and QRD template (v.9).
For products authorised in GB prior to 28 January 2022, there is currently no requirement to update your product information to the latest version of the GB-national SPC/QRD template. This is because, subject to conclusion of the formal consultation of our GB Veterinary Medicines Regulations (VMR), a further and final revision of this template will follow. We will provide further guidance on how to update your GB product information when this new template is available.
Should you wish to update your product information now, you should ensure parallel G.I.18 variation applications are submitted to us for both your GB and NI MAs. For variations of this category only, we accept submission of your GB product information presented in the and your NI product information presented in accordance with EUs v9 template .
For legacy UK-wide authorisations granted prior to 1 January 2021 under a European procedure, if you decide to submit a G.I.18 variation application at this time, we will need to issue separate authorisation documents with revised Vm numbers for NI and GB. These two Vm numbers will need to be included on your mock-ups and therefore you will need to allow space for these. In this instance we will still consider these authorisations to be aligned.
Common labelling
Applicants wishing to seek a common label between GB, NI and other EU Member States may seek to add the additional GB information required under the provisions of Article 13 of EU Regulation 2019/6 which allows applicants to request additional information on their labels that is compatible with the Summary of Product Characteristics. This will facilitate the continued ability to have a single joint label between the UK and the Republic of Ireland.
See
Package leaflet availability
EU 2019/6 requires applicants make readily available a package leaflet for every medicine authorised. For new NI-MRP or NI-Centralised applications validated on or after 28 January 2022 applicants will need to provide accompanying package leaflet text.
There is currently no GB requirement to produce a package leaflet for every veterinary medicine authorised. A package leaflet will continue to be required where it is not reasonably practicable to present all the necessary information on the immediate and outer label.