About the ABPI

The ABPI exists to make the UK the best place in the world to research, develop and use new medicines. We represent companies of all sizes who invest in discovering the medicines of the future. 

Our members supply cutting edge treatments that improve and save the lives of millions of people. We work in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines. Every day, we partner with organisations in the life sciences community and beyond to transform lives across the UK.

To get up to speed on the latest developments, the next briefing points from the BIA/ABPI are as follows:

Key themes and questions included in the consultation document

The scope of this consultation includes proposals from the MHRA on how it would handle various issues in the scenario of the UK not securing a deal with the EU after the UK’s exit from the EU. Topics covered by the consultation questions include:

  • Legal presence
  • New Marketing Authorisation assessment routes
  • Converting Centrally Authorised Products to UK Marketing Authorisations
  • Packaging
  • Paediatrics Investigations Plans and studies
  • Orphan designation
  • Abridged applications
  • Increased requirements for needing a manufacturer’s licence for import or a wholesaler dealer’s licence
  • Recognition of prescriptions
  • Clinical trials – legal presence, transparency, use of designated country lists and costs
  • Medical devices – registration and costs
  • Fees – waivers for orphan products, MHRA fees for processes previously provided by the EC/EMA and costs
  • Future operation of NIBSC

Media enquiries

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