S.L. 483.3 · sl/483.3 (S.L. 483.3)
S.L. 483.3 Art. 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.