Guidance

Quality and safety of human organs, tissues and cells if there's a no-deal Brexit

Guidance for hospitals, stem cell laboratories, tissue banks and fertility clinics for ensuring the quality and safety of human organs, tissues and cells (including reproductive cells).

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This page tells you what to do if there’s a no-deal Brexit. It will be updated if anything changes, including if a deal is agreed.

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You should continue to work to the same quality and safety standards as you do now if there’s a no-deal Brexit. The government has created statutory instruments to ensure we can retain the existing quality and safety standards.

If you import or export tissues or cells (including reproductive cells) to the EU, Norway, Iceland or Liechtenstein and there is a no-deal Brexit, you will need to apply for an import or export licence, update the licences you already have, or seek the appropriate approvals from the regulator.

Importing and exporting organs for transplantation if there’s a no-deal Brexit

Transplant centres do not need to take any further action. NHS Blood and Transplant (NHSBT) is working with UK regulator the Human Tissue Authority (HTA), to ensure that agreements are in place with EU organisations.

Importing and exporting non-reproductive tissues and cells for human use if there’s a no-deal Brexit

If you import or export non-reproductive tissues or cells from or to the EU, Norway, Iceland or Liechtenstein, and you do not already have an import or export licence, you will need to apply for one from the HTA.

If you already have an import licence

If you already have an import licence because you currently import from countries outside the EU, Norway, Iceland or Liechtenstein, you will need to apply to update this.

It will need to include the EU countries you are importing from, and Norway, Iceland or Liechtenstein if you import from those countries.

If you already have an export licence

If you already have an export licence because you currently export to countries outside the EU, Norway, Iceland or Liechtenstein, you do not need to do anything further. Your licence will cover the EU, Norway, Iceland and Liechtenstein if there’s a no-deal Brexit.

How long you will have

You will have 6 months after the UK leaves the EU to apply for or update your licence.

You should ask HTA for detailed guidance on import and export arrangements.

Importing and exporting reproductive cells if there’s a no-deal Brexit

If you import or export reproductive cells from or to the EU, Norway, Iceland or Liechtenstein you will need to have appropriate authorisation from the Human Fertilisation and Embryology Authority (HFEA).

You should now ask HFEA for detailed guidance on what requirements you will need to meet if there’s a no-deal Brexit.

How long you will have

You will have 6 months to comply with the requirements after the UK leaves the EU.

Ensuring traceability of tissues and cells if there’s a no-deal Brexit

You must continue to ensure the traceability of tissues and cells (including reproductive cells).

You will no longer need to use the Single European Code (SEC), unless you wish to do so.

You will be able to use the traceability systems you had in place before the introduction of the SEC.

UK establishments will no longer need to be added to the EU Coding Platform, which provides a list of all licensed establishments across the EU.

Statutory instruments

The government has created the following statutory instruments that ensure we can retain the existing quality and safety standards:

Published 15 February 2019
Last updated 8 August 2019 + show all updates
  1. Format updates have been made to highlight actions that people need to take, in particular relating to import and export licences. A link has also been added that allows people to sign up for email alerts to get the latest information about Brexit.
  2. First published.