Quality and safety of human blood and blood products

Quality and safety standards for blood and blood components

The UK quality and safety standards for blood and blood components are the same as before 1 January 2021. You should work to the same quality and safety standards as before 1 January 2021.

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

If you import blood or blood components into Great Britain from outside the UK, including from the European Economic Area (EEA), you must:

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• make sure that each imported unit of blood or blood component has been prepared in accordance with the standards equivalent to those set out in Annex I to Directive 2005/62/EC
• make sure that each imported unit of blood or blood component meets the quality and safety standards equivalent to those in Schedule 5 to the Blood Safety and Quality Regulations 2005
• have a description of ‘importation’ in section 4 of your blood establishment authorisation

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).

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You should treat movements of blood from Northern Ireland the same as movements of blood from Great Britain.

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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

If you receive blood or blood components into Northern Ireland, including from Great Britain, you must:

• make sure that each imported unit of blood or blood component has been prepared in accordance with standards equivalent to those set out in Annex I to Directive 2005/62/EC
• make sure that each imported unit of blood or blood component meets the quality and safety standards equivalent to those in Schedule 5 to the Blood Safety and Quality Regulations 2005
• have a description of ‘importation’ in section 4 of your blood establishment authorisation

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).

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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 (human medicines), you should ensure compliance 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.

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.

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