Guidance

Quality and safety of human organs, tissues and cells

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

• From: Department of Health and Social Care
• Published: 31 December 2020
• Last updated: 28 September 2021 — See all updates

Quality and safety standards for organs, tissues and cells

You should work to the same quality and safety standards as before 1 January 2021. The government made legislation to ensure the United Kingdom (UK) retained the same quality and safety standards after the end of the Brexit transition period on 31 December 2020.

For further information on the quality and safety standards you should ask the Human Tissue Authority (HTA) or the Human Fertilisation and Embryology Authority (HFEA).

Sending and receiving non-reproductive tissues and cells for human use if you are a tissue establishment in Great Britain

You should treat suppliers outside the UK as third country suppliers. This means if you import or export non-reproductive tissues or cells from or to a country outside the UK, you will need:

• an import or export licence
• for import, an import agreement with the third country supplier

This requirement came into force for import from and export to suppliers in the European Economic Area (EEA) on 1 July 2021.

You should treat the movement of non-reproductive tissues and cells from suppliers in Northern Ireland the same as the movement of non-reproductive tissues and cells from suppliers in Great Britain.

If you require further information, visit the HTA website for detailed guidance on import and export arrangements. You can also contact them directly for advice.

Sending and receiving non-reproductive tissues and cells for human use if you are a tissue establishment in Northern Ireland

You should treat suppliers in Great Britain in accordance with the relevant European Union (EU) regulations on non-EU suppliers. This means if you receive non-reproductive tissues or cells from Great Britain, you will need:

• an import licence
• an import agreement with the supplier in Great Britain

In line with the UK government's commitment to unfettered access, there are no additional requirements to send non-reproductive tissues or cells to Great Britain.

There are no additional requirements to send or receive tissues or cells to or from the EEA.

If you require further information, visit the HTA website for detailed guidance on import and export arrangements. You can also contact them directly for advice.

Sending and receiving reproductive tissues and cells for human use if you are a centre in Great Britain licenced by the HFEA

You should treat suppliers outside the UK as third country suppliers. This means if you import reproductive tissues or cells from a country outside the UK, you will need:

• an import certificate authorising imports from the third country supplier
• if multiple imports are to be undertaken, an import agreement with the third country supplier

For import from suppliers in the EEA this requirement came into force on 1 July 2021.

You should treat the movement of non-reproductive tissues and cells from Northern Ireland the same as the movement of non-reproductive tissues and cells from Great Britain.

If you require further information, you should ask the HFEA for detailed guidance on the requirements you need to meet.

Sending and receiving reproductive tissues and cells for human use if you are a centre in Northern Ireland licenced by the HFEA

You should treat suppliers in Great Britain in accordance with the relevant EU regulations on non-EU suppliers. This means if you receive reproductive tissues or cells from a supplier in Great Britain, you will need:

• an import certificate authorising imports from the third country supplier
• if multiple imports are to be undertaken, an import agreement with the third country supplier

In line with the UK government's commitment to unfettered access, there are no additional requirements to send reproductive tissues or cells to Great Britain.

If you require further information, you should ask the HFEA for detailed guidance on the requirements you need to meet.

Ensuring traceability of all tissues and cells

If you are a tissue establishment or fertility clinic in Great Britain, you must continue to ensure the traceability of tissues and cells (including reproductive cells). You no longer need to use the Single European Code, unless you wish to do so. You can use the traceability systems you had in place before the introduction of the Single European Code.

If you are a tissue establishment or fertility clinic in Northern Ireland, you must continue to use the Single European Code.

Declaring substances of human origin (blood, organs, tissues and cells) for UK import or export

See the HM Revenue and Customs (HMRC) guidance on import or export declarations for human organs, blood, tissues and cells needed for emergency use.

Published 31 December 2020
Last updated 28 September 2021 + show all updates

1. 28 September 2021

   Update reflects that the 1 July 2021 deadline in importing and exporting to suppliers in the European Economic Area (EEA) has now passed and measures are now enforced.

2. 27 May 2021

   A link to HMRC advice on declaring imports or exports of human organs, blood, tissues and cells has been added

3. 31 December 2020

   First published.