S.L. 458.51 Art. 2Interpretation. Cap. 458. Cap. 12. Cap. 378. S.L. 458.32

(1) In these regulations, unless the context otherwise requires: "the Act" means the Medicines Act;

"the Authority" means the Medicines Authority established under article 4 of the Act; "the Commission" means the Commission of the European Community; "Court of Appeal" means the Court of Appeal sitting in its inferior jurisdiction as constituted in terms of article 41(9) of the Code of Organization and Civil Procedure; "the Directive" means the provisions of Directive 98/27/EC of the European Parliament and of the Council of 19th May, 1998 on injunctions for the protection of consumers’ interests;

"EEA State" means any State which is a contracting party to the agreement on the European Economic Area signed at Oporto on the 2nd May, 1992 as amended by the Protocol signed at Brussels on 17th March, 1993 and as amended from time to time; "European Community" means the organisation established by the Treaty of Rome in 1957 and amended institutionally and otherwise in 1986 by the Single European Act, in 1993 by the Treaty on European Union, in 1997 by the Treaty of Amsterdam and in 2001 by the Treaty of Nice and as amended by accession agreements and as may be further amended from time to time;

"list of qualified entities" means the list compiled and updated by the Commission and published in the Official Journal of the European Communities listing the qualified entities in Member States and EEA States in accordance with Article 4 of the Directive;

"medicinal products" means medicinals for human use; "Member State" means a member of the European Community; "the Minister" means the Minister responsible for health;

"qualified entity" means any body or organization which, being properly constituted according to the law of a Member State, has a legitimate interest in ensuring that the provisions referred to in regulation 3 are complied with and, without prejudice to the generality of the foregoing, includes:

(a) a registered consumer association within the meaning of Part IV of the Consumer Affairs Act;

(b) one or more independent public bodies, having a legitimate interest in ensuring the protection of the collective interests of consumers of medicinal products advertising in other Member States or EEA States in which such bodies exist;

(c) voluntary organisations in other Member States or EEA States whose purpose is to protect the interests referred to in paragraph (a) of this definition in accordance with the criteria laid down by their national law;

(d) organisations recognised by the Authority as collectively representing medicinal products manufacturers, suppliers and distributors; or

(e) any qualified entity from a Member State or EEA State included in the list of qualified entities; "the 2005 Regulations" means the Medicinal Products

(Advertising) Regulations.

(2) Words and expressions used in these regulations which are also used in the Act or in the 2005 Regulations shall have the same meanings as in the Act or in the said regulations.