#Vmd citation update

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 will of course consult industry on this in due course. 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. Future engagement and contingency measures As always, we will keep you regularly updated with developments. 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. In either event, the Bill will enable us to provide a long-term fix to supply concerns. Alternatively the EU could adjust its own legislation, as they have done for human medicines. 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. This would remove regulatory barriers and supply challenges that will arise should the grace period end at the end of 2022. 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. 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. If we can’t 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. Despite strong industry concern about the EU’s current position on imposing import requirements at the end of 2022, the EU has not proposed any long-term solutions for veterinary medicines. Veterinary medicines are covered under the ‘manufactured goods, medicines and agri-foods’ references within the regulation of goods section (clauses 7-11). Also published was a problems and solutions document and the press release. 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. On 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.

#Vmd citation update

Northern Ireland update Introduction of the Northern Ireland Protocol Bill Information Hub explainers Explainer subjectĮxplainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to applications and authorisations for veterinary medicinesĮxplainer for Marketing Authorisation holders, wholesale dealers, retailers (including veterinary surgeons) and feed business operators on the manufacture and movement of veterinary medicines.Įxplainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to Pharmacovigilance.Įxplainer 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)Įxplainer 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).Įxplainer 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).Įxplainer 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). 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.

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. This is the Hub for all the Veterinary Medicines Directorate’s communications on current and future regulatory changes.