S.L. 458.35 Art. 1Citation, purpose and scope.

(1) The title of these regulations is the Pharmacovigilance

Regulations.

(2) These regulations implement the provisions of Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use.

(3) These regulations shall apply to authorised medicinal products for human use and any pharmacovigilance activity connected therewith.