Pharma and Brexit: an update

08/08/2018 | Corinna Herkenhoff
Bolte

Corinna Herkenhoff
Consultant

The British MHRA recently published some “Guidance” relating to the impact that a transitional agreement would have on the healthcare sector if it became part of the final Withdrawal Agreement. Ultimately, the many “what ifs” mean that everything could stay the way it is. However, barely seven months before Brexit is supposed to take place, a lot is still unclear. Just last year, we reported on the relationship between the pharmaceutical industry and Brexit with the headline, “the clock is ticking”. This headline is now more relevant than ever before.

The MHRA’s „Technical information on what the implementation period means for the life science sector“, which was published on 06 August 2018, stipulates that:

  • market access will not change during the implementation period;
  • batch release testing in the UK will continue to be recognised by the EU and vice versa;
  • authorisation holders, QPs and QPPVs will be able to keep their headquarters in the United Kingdom and will therefore have continued access to EU markets;
  • manufacturing and wholesale distribution licences will continue to be recognised by the EU and vice versa, as will inspections; and
  • companies based in the United Kingdom will be able to keep participating in centralised and decentralised marketing authorisation procedures.

However, caution is advised, as the MHRA also includes the following disclaimer: “This document does not constitute legal advice and companies should seek independent legal advice dependent on their specific circumstances.”

Perhaps the “Guidance” document is a response to the British Parliament’s recent vote to remain part of the EMA. How the EMA – or rather, the EU Commission – will respond to this request remains to be seen. This point will surely be just one element of many in the negotiations that are to follow.

The EMA meanwhile sticks to its course: „EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.”

The difference between the MHRA and EMA press releases echoes the ongoing uncertainty about the outcome of the Brexit negotiations. We will be happy to help you evaluate which strategy is right for your company. Get in touch with us!

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