S.L. 458.33 Art. 2Interpretation.

For the purposes of these regulations:

"the Commission" means the Commission in accordance with

Council Decision 1999/468/EC of 28 June, 1999;

"common name" means the international non-proprietary name recommended by the World Health Organisation, or, if such name does not exist, the usual common name; "electronic package leaflet" means the package leaflet displayed in an electronic format in an official language or official languages of Malta and which is accessible through a machine-readable format displayed on the outer packaging of the medicinal product, and where the outer and immediate packaging is not in the official language or languages of Malta, it shall include the particulars to be found on the outer and immediate packaging of medicinal products in accordance with the provisions of these regulations; "immediate packaging" means the container or other form of packaging immediately in contact with the medicinal product; "labelling" means information on the immediate or outer packaging; "name of the medicinal product" means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder;

"outer packaging" means the packaging into which the immediate packaging is placed;

"package leaflet" means a leaflet containing information for the user which accompanies the medicinal product; "representative of the marketing authorisation holder" means the person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned; "strength of the medicinal product" means the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.