Detailed guide: Quality and safety of human blood and blood components from 1 January 2021

Quality and safety standards for blood and blood components

From 1 January 2021, you should continue to work to the same quality and safety standards as you do now. The government has made legislation and has laid a further draft regulation before Parliament to ensure the UK retains the existing quality and safety standards after the end of the transition period on 31 December 2020.

Receiving blood or blood components if you are a blood establishment in Great Britain

From 1 January 2021, if you import blood or blood components into Great Britain from outside the UK, including from the European Economic Area (EEA), you must:

If you do not have the necessary importation permissions on your Blood Establishment Authorisation, a variation request should be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA).

In line with the UK governments commitment to unfettered access, there are no changes to the requirements to receive blood and blood components from Northern Ireland.

If you require further information, ask the MHRA for further guidance on import and export arrangements.

Receiving blood and blood components if you are a blood establishment in Northern Ireland

From 1 January 2021, if you receive blood or blood components into Northern Ireland from outside the EEA, including from Great Britain, you must:

If you do not have the necessary importation permissions on your Blood Establishment Authorisation, a variation request should be submitted to the MHRA.

There are no changes to the requirements to receive blood and blood components from the EEA.

If you require further information, ask the MHRA for further guidance on import and export arrangements.

If you are a manufacturer of blood products

If you are a manufacturer of blood products, you should comply with the current UK requirements for the collection and testing of human blood and human plasma, for use in the manufacture of blood products.

These are the requirements set out in the Blood Safety and Quality Regulations 2005.



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