Pharmaceutical

Pharmaceuticals, EMA & Brexit – What’s It All Mean?

By November 20, 2020 No Comments
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Pharmaceuticals, EMA & Brexit
What’s It All Mean?

 

The EMA (European Medicines Agency) announced earlier this year some
important guidelines and updates concerning the regulatory status for
pharmaceuticals following the Brexit deadline on 31 st January.
Pharmaceutical law will remain applicable to the UK through the end of 2020.
This will ensure the EMA can continue to deliver on its mission to protect public
and animal health throughout the transition process.

During the transition period, pharmaceutical companies can continue to carry out
activities in the UK until the end of 2020. However, the UK no longer participates
in EU institutions, this means that no-one who represents the UK, or is appointed
or nominated by the UK can participate in any EMA scientific committee meeting,
working party meeting or in the Agency’s Management Board.

Brexit Impact on EMA Activities

One of the key physical consequences of Brexit was that the EMA headquarters
have been moved to Amsterdam. At which time a business continuity plan was
put in place to keep focus on the highest priority activities, temporarily scaling
back or suspending lower priority activities as required:

Regulatory Preparedness

In preparation for Brexit, the EU27 Member States and EMA redistributed the
UK’s portfolio of medicines to the other EU Member States. This involved transferring
over 370 centrally authorised products to the EU27 plus Iceland and Norway.

In 2018, the EMA informed the relevant marketing authorisation holders of the
medicines.  In September 2018, the new holders received a knowledge
transfer package for each product. This contained background on the regulatory
and evaluation history of each product, including the most recent benefit-risk
assessment.

The transfer package also helps each national competent authority forecast upcoming
workload and support the planning of resources, particularly for complex products in
the portfolio.  The new holders have been fully responsible for these medicines since 1 July
2019.

More information and the full report can be found at www.ema.europa.eu