xmlns:atom="http://www.w3.org/2005/Atom"
11. After regulation 16 (records to be kept by the Secretary of State), insert the following regulation—
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reactions and events in order to guarantee that blood or blood components known or suspected to be defective are withdrawn from use and discarded.”.