February 6, 2019

No deal brexit’s impact on the pharmaceutical and medical devices industries: guidance from the ema and the european commission

On January 15, 2019, the UK House of Commons rejected the withdrawal agreement reached by Theresa May and the EU after a long and exhausting negotiation period of almost 2 years. On March 29, 2019, the UK will officially leave the EU unless Article 50 of the Treaty on European Union is delayed or revoked. A delay in the UK leaving the EU seems to be the most reasonable and conservative option at this stage, but the future is profoundly uncertain and a No Deal Brexit is becoming an increasingly more realistic possibility by the day.

In relation to the above, the European Medicines Agency and the European Commission are providing guidance on Brexit for pharmaceutical companies, including launching a dedicated page on their website.

On February 1, 2019, the European Commission published an updated Q&A document on the topic of the UK’s withdrawal from the EU with regard to industrial products, including medical devices, and medical products for human and veterinary use, which can be viewed at the following links:

–          Medical products for human and veterinary use

–          Industrial products, including medical devices

These FAQs address the scenario in which the UK will leave the EU without any transition period or without any other arrangements being put in place, and therefore having a potentially disruptive impact on businesses. In this case, the UK will immediately become a third country from the EU’s perspective.

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