EU Regulations 2019/6 and 2019/4 will not be implemented in Northern Ireland

✔ Fact Checked by TDPel News Desk

By Pelumi Emmanuel

Published: January 28, 2022 | 10:04 AM

In line with the Government announcement on maintaining standstill arrangements in September 2021, 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).

Recognising that EU medicines approval processes are essential to maintain availability of medicines for the UK, as an interim measure we have established ways to bridge this gap between the EU Legislation and the current VMR, as they have effect in GB and NI, whilst still respecting both sets of legislation. Details of these mitigations are on our Information Hub.

The operation of the Protocol will continue on the current basis to give certainty and stability to businesses while UK-EU discussions continue.

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About Pelumi Emmanuel

Pelumi Emmanuel is an accomplished writer and journalist with over 15 years of experience in the industry. He is a passionate and dedicated professional who is committed to producing high-quality content that informs, engages, and entertains readers. Pelumi’s love for reading and writing is evident in his work, which has been read worldwide and has garnered him a loyal following. His journalistic expertise is matched only by his natural talent for storytelling, making his articles both informative and engaging. He lives in California, USA.