What you need to do to ensure the safety and quality of blood and blood products
Leaving the EU with a deal remains the government’s top priority. This has not changed. However a responsible government must prepare for every eventuality, including a no-deal scenario.
If the UK leaves the EU without a deal it will become a third country operating outside of EU rules. There will be some changes to the way you import and export blood and blood components, and you must prepare your organisation for the new situation.
Quality and Safety
The UK will retain the existing quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components. This means that if you are a blood establishment, blood bank or manufacturer of blood products you will continue to work to the same quality and safety standards as you do now.
Importing blood or blood components from the EU
If you import blood or blood components into the UK from the EU or EEA countries 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
You are advised to consult with the Medicines and Healthcare products Regulatory Agency (MHRA) before importing blood or blood components from the EU and EEA.
Exporting blood or blood components to the EU
If you export blood or blood components from the UK to any EU or EEA country, 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 certify that any products you export comply with these standards.
You are advised to consult with the MHRA before exporting blood or blood components to the EU or EEA.
Manufacturers of blood products
You should continue to comply with Directive 2002/98/EC for the collection and testing of human blood and human plasma, for use in the manufacture of blood products.
Government contingency plans
The government has prepared for a no-deal Brexit by creating the following statutory instrument:
The statutory instrument will be needed if the UK leaves the EU without a deal. Depending on the outcome of the negotiations, it can be revoked or amended as required.
The changes made by the statutory instrument ensure that the requirements, in relation to the quality and safety of blood, will remain broadly the same once the UK leaves the EU.
This also makes necessary changes to reflect that the UK and EU countries will consider each other as third countries if there is no deal. This means that licensed blood establishments will need to make administrative changes, as detailed above, to continue to import blood and blood components from EU countries.
DHSC is working closely with blood establishments and other partners to ensure that the collection, manufacture and supply of blood and blood components will continue to function as normal and will meet patient demand, regardless of whether the UK leaves the EU with or without a deal.