Agnieszka Zimmermann, Piotr Malach
Import docelowy produktów leczniczych
Direct imports of medicinal products. The article describes the principles of direct imports of medicinal products. Pursuant to Pharmaceutical Law drugs are admitted to trading on the basis of a proper permit issued by the Minister of Health, Council of the European Union or by the European Commission. However, products imported from abroad for a patient's individual needs, i.e. direct imports, are not required to have such a permit. A drug may be imported within the framework of the procedure in question if its use is essential for saving a patient's life or health. However, specific conditions need to be fulfilled. The preparation has to be admitted to trading and have an up-to-date permit issued by the country from which it is imported. The basis for importing a medicinal product being demand by a hospital or by a doctor in charge of treatment outside hospital certified by a consulting physician in a given domain of medicine and by a minister competent for health. The article also discusses the controversies connected with legalising the so called direct imports for economic reasons, which refers to medicinal products containing the same substance or substances, the same dose as medicinal products that have already been given a permit but whose prices are competitive in relation to the price of a medicinal product which has already been given a permit.
Keywords: medicinal product, legislation, drug market.