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One Country, Two Regulatory Systems: Another Brexit Headache

Northern Ireland’s Special Status Poses Major Challenges

Executive Summary

The Northern Ireland Protocol brings added complexities that for medicines regulation in the UK, particularly in areas such as new drug approvals and batch release procedures.

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UK/EU Industry ‘Still Working In The Dark’ On Post-Brexit Regulation

As the final scheduled round of post-Brexit trade talks begins amid growing concern over the prospect of a deal and the pervasive threat of COVID-19, pharmaceutical industry bodies in the UK and the EU have issued an urgent call for an MRA on medicines GMP. They also want to see a one-year phase-in of medicines-related aspects of the Northern Ireland Protocol.

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As negotiators struggle to reach agreement on the future UK/EU relationship, pharma firms have been warned to expect major hold-ups next year for medicines crossing the Channel. 

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Pharmaceutical companies in the UK have again been asked to ensure they have contingency measures in place to deal with potential supply problems at channel ports – this time in preparation for the UK’s formal departure from the EU’s single market and customs union at the beginning of 2021. The industry is continuing to push for a mutual recognition agreement on drug regulation.

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