News - June 12, 2019

Brexit: EC Communication on Contingency Measures

The European Commission published on the 12 June its 5th state-of-play communication on the preparation of contingency measures for the withdrawal of the United Kingdom from the European Union (Brexit).

In its 10-page document, the Commission reiterates its recommendation for a high level of preparedness across all sectors to mitigate the negative impact of a potential no-deal Brexit.

While the Commission does not speculate on the possible economic implications of different scenarios, it is clear that a withdrawal of the United Kingdom without an agreement would have a serious negative economic impact, and that this impact would be proportionally much greater in the United Kingdom than in the EU27 Member States. COM 2019/276.

Regarding the specific pharmaceutical and medical technologies sectors, the Commission strongly encourages the pharma industry to:

  • use the extension period to bring remaining medicinal products into regulatory compliance for marketing authorisation by 31 October 2019;
  • explore the possibililty to obtain a temporary exemption for the transfer of batch testing facilities from the UK to the EU27.

Regarding the transfer of certificates for medical devices from UK Notified Bodies to EU27 ones’, the Commission notes that significant work will still be required to achieve full compliance by 31 October 2019 (date of latest Article 50/3 extension). And in cases where UK Notified Bodies will not be able to transfer those certificates, the Commission is strongly encouraging the medical devices companies to take the matter in their own hands, with the support of the Member States.

The communication will be used as a guidance document for the Council meeting of 20 and 21 June, where Member States will take stock of the progress of the extension process of the Withdrawal Agreement.

The full document and its annexes can be accessed here.