Insertion of regulation 10A10

After regulation 10, insert—

10A

After regulation 13 insert—

Import of blood and blood components into Northern Ireland13A

Any person who imports blood or blood components into Northern Ireland from a third country must ensure that each unit which they import—

a

has been prepared in accordance with standards equivalent to the standards and requirements set out in the Annex to Commission Directive 2005/62/EC; and

b

meets standards of quality and safety equivalent to those laid down in Part 5 of the Schedule.