The Government’s intention to ’maintain regulatory alignment’ with the European Medicines Agency has been welcomed by the House of Commons’ Health and Social Care Committee.

Its report following an inquiry into ‘Brexit: medicines, medical devices and substances of human origin’ also says it is vital that the UK life sciences sector is able to continue to participate in Europe-wide clinical trials.

But the report, published on March 21, warns that the EU has ruled out a sector-by-sector approach, and that any provisions which are put in place for continued co-operation between the EU and the UK in the life sciences are dependent on similar agreements being made across the whole of the negotiations.

On this basis it says it is essential that scrutiny is undertaken of the DHSC’s contingency planning for a ‘no deal’ situation.

The report, which has been welcomed by the Healthcare Distribution Association and other industry bodies, urges UK and EU negotiators to prioritise patient safety in the next round of Brexit negotiations. Other key recommendations of the Committee include:

  • The transposition of Good Distribution Practice into UK law
  • UK membership of all the chief EU pharmacovigilance systems and databases
  • ‘Free and frictionless trade’ with the European Union
  • An impact assessment on the loss of parallel imports.



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