Insertion of regulation 16A

11.  After regulation 16 (records to be kept by the Secretary of State), insert the following regulation—

“Requirement that the Secretary of State communicate certain information to other competent authorities

16A.   The Secretary of State shall communicate to the competent authorities of other 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reactions and events in order to guarantee that blood or blood components known or suspected to be defective are withdrawn from use and discarded.”.