Regulation 11 I1F1

For regulation 16A substitute—

“Requirement that the Secretary of State communicate certain information in respect of Northern Ireland to other competent authorities

16A.

The Secretary of State must, in respect of Northern Ireland, communicate to the competent authorities of member States such information as is appropriate with regard to serious adverse reactions and events in order to guarantee that blood or blood components known or suspected to be defective are withdrawn from use and discarded.”.”.