S.L. 458.57 Art. 1Citation and scope.

(1) The title of these regulations is the Pharmacovigilance Inspections Regulations.

(2) These regulations shall apply to authorised medicinal products for human use, their marketing authorisation holder and any pharmacovigilance activity connected therewith.

(3) 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 inspections, Directive 2001/83/EC on the Community code relating to medicinal products for human use.