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.
Posted by Dr. Tim Sandle
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