S.L. 458.40 Art. 2Interpretation.

For the purpose of these regulations -

"the Act" means the Medicines Act;

"the Commission" means the Commission of the European Union;

"Maltese-market product" means the medicinal product for which a marketing authorisation has been granted in Malta, with which the parallel imported medicinal product is compared; "Member State" means a State which is a member of the European Union;

"parallel distribution" means the importation from a Member State or a country within the European Economic Area of a centrally authorised medicinal product, by an importer who is someone other than the importer authorised and appointed by the marketing authorisation holder of the product on the Maltese market; "parallel importation" means the importation from a Member State or a country within the European Economic Area of a medicinal product which is already authorised on the Maltese market, by an importer who is someone other than the importer authorised and appointed by the marketing authorisation holder of the product on the Maltese market; "parallel importer" means a person engaged in the activities of parallel importation; "parallel imported product" means a product authorised in a Member State or a country within the European Economic Area imported by parallel importation; "repackaging" includes the removal of blister packs from the original packaging and their insertion into new external packaging or addition of new user instructions or information or the fixing of self-stick labels;

"source country" means the Member State country from which the parallel imported product is imported.