S.L. 483.3 ст. 1Citation and scope.

(1) The title of these regulations is the Traceability Requirements and Notification of Serious Adverse Reactions and Events Regulations.

(2) These regulations implement Directive 2005/61/EC implementing Directive 2002/98/EC of the European Parliament and of the Council of the 27th January, 2003 relating to traceability requirements and notification of serious adverse reactions and events.