Veterinary Medicines Directorate
VMD Information Hub
This is the Hub for all the Veterinary Medicines Directorates communications on current and future regulatory changes.
You can sign up to receive email alerts for all our news and announcements through GOV.UK to make sure you get the latest information as soon as it becomes available. In addition to this we have a mailing list for those in your organisation only interested in receiving updates made to the Hub and other regulatory transition related information. Email vedmedtrade@vmd.gov.uk to register.
Information Hub explainers
| Explainer subject | Summary |
|---|---|
| Application and authorisation | Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to applications and authorisations for veterinary medicines |
| Manufacturing and distribution | Explainer for Marketing Authorisation holders, wholesale dealers, retailers (including veterinary surgeons) and feed business operators on the manufacture and movement of veterinary medicines. |
| Pharmacovigilance | Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to Pharmacovigilance. |
| Mitigation explainer: Pharmacovigilance | Explainer for the pharmaceutical industry on Pharmacovigilance requirements mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR) |
| Mitigation explainer: Labelling text | Explainer for the pharmaceutical industry on labelling text mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR). |
| Mitigation explainer: Variations | Explainer for the pharmaceutical industry on variation related mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR). |
| Mitigation explainer: Renewals | Explainer for the pharmaceutical industry on Renewal requirements mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR). |
Northern Ireland update
European Commission Statement 19 December 2022
On 19 December 2022, the European Commission issued the following statement by Vice-President Maro ef?ovi? which provides for a three-year extension to the grace period for veterinary medicines until 31 December 2025.
These arrangements will mean that the current processes for moving veterinary medicines between Great Britain and Northern Ireland will continue to be administered as they have been up to this point.
We welcome this extension to the veterinary medicine grace period from the Commission and are looking forward to further discussions on veterinary medicines in the New Year. We will continue to work for a long-term, sustainable solution to the supply of veterinary medicines.
We welcome your feedback, please send your comments to niprotocol@vmd.gov.uk and encourage you to continue lobbying the European Commission both on defining the issues faced by veterinary medicines and the need for a sustainable, permanent solution
Introduction of the Northern Ireland Protocol Bill May 2022
On 17 May 2022 the Foreign Secretary set out to the House of Commons that primary legislation would be brought forward to restore the balance inherent in the objectives of the Protocol - avoiding a hard border, protecting the integrity of the UK and safeguarding the EU Single Market.
The Northern Ireland Protocol Bill was introduced to Parliament on 13 June and a statement that summarises the legal position was published, that such legislation is lawful under international law. Also published was a problems and solutions document and the press release.
Veterinary medicines are covered under the manufactured goods, medicines and agri-foods references within the regulation of goods section (clauses 7-11). Despite strong industry concern about the EUs current position on imposing import requirements at the end of 2022, the EU has not proposed any long-term solutions for veterinary medicines. If we cant reach a negotiated agreement with the EU on all veterinary medicines, we will use the Bill to ensure continuity of supply of veterinary medicines throughout the UK.
The Bill
The Bill will provide us with the powers to disapply elements of EU law under the Protocol, for example those relating to EU rules on veterinary medicines. The Bill also provides the power for Ministers to make new law in connection with the Protocol, which could be used to create a UK-wide veterinary regime. This would remove regulatory barriers and supply challenges that will arise should the grace period end at the end of 2022.
We would like to reach a negotiated arrangement with the EU on veterinary medicines and if we are able to do this, the Bill will provide us with the powers to implement this, if necessary. Alternatively the EU could adjust its own legislation, as they have done for human medicines. In either event, the Bill will enable us to provide a long-term fix to supply concerns.
Nothing is changing for now
In the short-term, there will be no changes as the Bill may take up to 12-months to go through the parliamentary approval process and gain Royal Assent. As always, we will keep you regularly updated with developments.
Future engagement and contingency measures
The Bill will allow us to go back to a single UK-wide regime which will simplify and address the supply and regulatory issues caused by the Protocol for NI. We will of course consult industry on this in due course.
If the Bill is not passed by the end of 2022 (and the end of the grace period), the UK will consider further measures to protect the supply of veterinary medicines in NI.
We welcome feedback on the proposals within the Bill to NIProtocol@vmd.gov.uk.
EU Regulation 2019/6 and EU Regulation 2019/4 will not be implemented in Northern Ireland January 2022
In line with the Government announcement on maintaining standstill arrangements in September 2021, below, and while discussions on veterinary medicines continue, EU Regulation 2019/6 and EU Regulation 2019/4 will not be implemented in Northern Ireland from 28 January 2022, except for areas previously agreed in relation to the operational aspects concerning applications for new marketing authorisations and associated life-cycle management (variations, renewals, QRD text and pharmacovigilance).
EU Regulation 2019/6 does not apply to vets and veterinary medicines in Northern I