What does IP completion day mean for clinical trials?
What does IP completion day mean for clinical trials?

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • What does IP completion day mean for clinical trials?
  • Overview—what happened on 31 December 2020
  • How does Brexit impact clinical trials?
  • What are the key legal authorities in this area?
  • What guidance is available from the UK government?
  • What guidance is available from the EU?
  • What are the key items of retained EU law? Are they subject to amendment from IP completion day?
  • What are the key requirements for sponsors from IP completion day?
  • What are the key requirements for clinical trial registrations from IP completion day?
  • What are the key requirements for the submission of clinical trial information and safety reports from IP completion day?
  • More...

11 pm (GMT) on 31 December 2020 marked the end of the implementation period put in place to enable the UK to transition away from the EU’s laws and institutions. At that point in time (referred to in this document as ‘IP completion day’) there was an immediate and significant change in the UK’s legal regime. This Practice Note explains the implications of this change in relation to the following aspects of clinical trials:

  1. Overview—what happened on 31 December 2020

  2. How does Brexit impact clinical trials?

  3. What are the key legal authorities in this area?

  4. What guidance is available from the UK government?

  5. What guidance is available from the EU?

  6. What are the key items of retained EU law? Are they subject to amendment from IP completion day?

  7. What are the key requirements for sponsors from IP completion day?

  8. What are the key requirements for clinical trial registrations from IP completion day?

  9. What are the key requirements for the submission of clinical trial information and safety reports from IP completion day?

  10. What are the key requirements for the supply and import of investigational medicinal products (IMPs) from IP completion day?

  11. What are the key requirements for the publication of clinical trial results from IP completion day?

  12. What is the sector/market approach?

  13. What is in the pipeline beyond IP completion day?

  14. What are the key

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