[co-author: Vicky Vlontzou]
On 9 July 2020 the European Commission adopted a Communication regarding readiness at the end of the transition period between the European Union and the United Kingdom. The Communication sets out a sector-by-sector overview of the main areas where changes are anticipated regardless of the outcome of the ongoing EU-UK negotiations. It also sets out measures that national authorities, businesses and citizens should take in order to prepare for these changes. Among the sectors affected by these changes according to the Communication are the medicinal products and medical devices sectors.
On 9 July 2020, the European Commission adopted a Communication that sets out a sector-by-sector overview of the main areas in which changes are anticipated regardless of the outcome of the ongoing EU-UK negotiations. It also sets out measures that national authorities, businesses and citizens should take in order to prepare for these changes. The document is intended to ensure that public administrations and stakeholders will be prepared for the unavoidable disruptions caused by the UK's decision to leave the EU and to end the transition period at the end of 2020.
Among the sectors affected by the changes resulting from the departure by the UK from the EU that are addressed in the Communication are the medicinal products and medical devices sectors.
The Communication recalls that from 1 January 2021, the United Kingdom will exit the European Union's regulatory system for medicinal products and medical devices. As a result:
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All market authorization holders for medicinal products will need to be established in the European Union;
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Testing and batch release sites for medicinal products will need to be located in the European Union;
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Qualified persons responsible for pharmacovigilance and batch release (including investigational medicinal products) will need to be established in the European Union;
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Any clinical trials authorized in the European Union will need to have a sponsor or a legal representative established in the European Union;
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Information and labeling will have to comply with the EU requirements including co-labeling of medicinal products according to the terms of the marketing authorization granted in the UK;
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The certification of medical devices will have to be carried out by notified bodies established within the European Union.
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