Friday, 22 June 2018

MHRA on Brexit


MHRA update to pharmaceutical companies on exit preparations. MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.

The UK’s intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree a deep and special future partnership. MHRA will continue to advise businesses on the basis of the UK position and will continue to work with the EMA in planning for the UK’s withdrawal from the EU and future relationship.

Companies have been asking for detail about UK legislative requirements in different scenarios. MHRA has been working closely with industry associations and other stakeholders and further details on all these issues and more – both Day One and longerterm proposals – will be published when appropriate.

The UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period,
MHRA’s approach would be in line with the following principles:

The European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.

MHRA would be pragmatic in establishing UK regulatory requirements. We would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.

Where possible, MHRA would be making use of the information it already has to complete administrative tasks for continuity of work and licences.

MHRA would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.

See: https://www.gov.uk/government/news/mhra-update-to-pharmaceutical-companies-on-exit-preparations

Posted by Dr. Tim Sandle

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