What blood establishments, blood banks and manufacturers of blood products need to do to ensure the safety and quality of blood and blood products.
Importing blood or blood components
If you import blood or blood components into the UK from the EU, Norway, Iceland or Liechtenstein you must:
- make sure that each imported unit of blood or blood component is prepared in accordance with Directive 2005/62/EC
- make sure that each imported unit of blood or blood component meets the quality and safety standards in the existing Blood Safety and Quality Regulations 2005
- add a description of activity to cover importation on your blood establishment authorisation
It is recommended that you consult with Medicines and Healthcare products Regulatory Agency (MHRA) before importing blood or blood components.
Exporting blood or blood components
If you export blood or blood components from the UK to the EU, Norway, Iceland or Liechtenstein, you must make sure that each unit of blood and each blood component exported:
- meets the EU testing requirements (Annex IV, Directive 2002/98/EC4)
- meets the equivalent standards of quality and safety (Annex V, Directive 2004/33/EC5)
You may need to demonstrate to the country you’re exporting to that any products you export comply with the relevant standards.
It is recommended that you consult with MHRA before exporting blood or blood components.
Manufacturing blood products
Manufacturers of blood products 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 Directive 2002/98/EC.
Quality and safety of human blood and blood products from 1 January 2021
From 1 January 2021, you should continue to work to the same quality and safety standards as you do now. You will not need to change your current practice.
This is because the UK will maintain the existing quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components.
Before importing or exporting blood and blood components from the EU, Norway, Iceland or Liechtenstein you should consult with the MHRA.