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Quality and safety of human organs, tissues and cells from 1 January 2021

Quality and safety of human organs, tissues and cells from 1 January 2021
November 18, 2020 SueCarr

The government has made legislation and laid further draft regulations before Parliament to ensure the existing quality and safety standards for organs, tissues and cells remain the same after the end of the transition period.

For organisations such as hospitals and tissue establishments this means (for non-reproductive tissues/cells):

  • Stake holders should continue to work to the same quality and safety standards after 1 January 2021
  • those who send and receive tissues/cells will need an import/export license (must be in place by end of June 2021)
  • Organisations in Northern Ireland (NI) will need to treat GB suppliers in accordance with relevant EU regulations on non-EU suppliers. This means an import licence and import agreement must be in place with the GB supplier when importing tissues into NI. There are no changes for sending tissues/cells from NI to GB.
  • Tissue establishments must still ensure the traceability of the tissues/cells, but may use a system without the Single European Code.
  • In contrast, tissue establishments in NI must continue to use the Single European Code.

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