UK shares Brexit implementation plans for life sciences
The UK government today published four documents about how Brexit will impact the operations and regulatory status of life sciences companies.
In a document titled “ What the implementation period means for the life sciences sector”, the government said that the transitional period between Brexit being effective on March 29, 2019 and implemented from December 31, 2020 will give businesses more time to consider and prepare for the implications of Brexit.
During the implementation period, the government explained, marketing authorisation (MA) holders can continue to be based in the UK and access the EU market. Also, UK-based companies can continue to apply for MAs during this time.
In another document, “ Technical information on what the implementation period means for the life science sector”, the government confirmed that market access will not change during the implementation period.
It confirmed that a licence for a centrally authorised product (CAP) will be valid for the EU and the UK during the implementation period.
Products that have not finished a centrally authorised assessment process at the end of the implementation period may have to start again in the UK after December 2020, depending on future Brexit negotiations, the government said.
Under EU law, MA holders for CAPs need to be based in the European Economic Area to be able to market a medicine in the EU.
The government noted that it will be “pragmatic” in transferring CAPs to UK licences, though it cannot predict when this will happen.
This promise comes shortly after the European Medicines Agency (EMA) expressed concerns about how prepared medical MA holders are for the UK’s departure from the EU.
Another document released today, called “ UK notified bodies for medical devices”, lists four bodies in the UK that are able to issue CE certifications. CE marking for medicinal devices will continue to be used and recognised in the UK and EU markets over the course of the implementation period, the government said.
The government has also shared its intention to adhere to the new clinical trials regulation, which is expected to apply from 2020. In a document titled “ Clinical Trials Regulation”, the government said that the new regulation will enable a streamlined application process and harmonised assessment procedure.
It added that even if the new regulation does not come into force during the implementation period, UK law will remain aligned with as much of the regulation as it can.
The two elements that the UK would not be able to implement on its own are use of a shared central IT portal and participation in the single assessment model, as these would require an agreement with the EU after the implementation period.
Last month, the UK Parliament voted in favour of the UK’s continued participation of the EMA, but the remaining 27 EU member states would need to approve this.
Also last month, the UK government’s latest White Paper on Brexit indicated that the UK is seeking a “common rulebook” for human and animal medicine so that manufacturers need to go through only one series of tests in either the UK of the EU.
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