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BREXIT Updated Impact Statement

14 May 2018  
Posted by: Tamsin Marshall
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BREXIT Updated Impact Statement

 

It's less than a year until the UK leaves the EU. Every day passing leaves less time to deal with the (potential) impact and for pharma companies worldwide which supply the EU, its MRA partners and / or UK to be able to legally continue to supply patients in the those territories with medicines. What steps are definitely needed will probably not become clear until some time in the Transition Period which currently planned to end 31 Dec 2020.

At present UK Govt continues to "assure" that all will be well, but the EU seems to have a different take on the matter. Main issues are:-

  •  QP certification processes
  •  Siting / re-siting of finished product testing labs 
  •  Analytical transfers
  •  Licence amendments to reflect the above in both UK and EU 
  •  New licence approvals 

 

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