S.L. 458.33 Art. 1Title and scope.

(1) The title of these regulations is the Medicinal Products

(Labelling and Packaging) Regulations.

(2) The scope of these regulations is transpose Directive 2001/ 83/EC, and to transpose amendments to Directive 2001/83/EC on the Community code relating to medicinal products for human use, brought about by Directive 2010/84/EU, as regards pharmacovigilance, Directive 2011/62/EU, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, and Directive 2012/26/EU, as as regards pharmacovigilance.