Opinia prawna stanowiąca uzupełnienie opinii na temat obowiązku wprowadzenia przez Polskę do sprzedaży aptecznej bez recepty produktu leczniczego ellaOne

The author provides an analysis of Poland’s obligations as a Member State of the European Union, relating to the implementation of Community law in so far as it concerns Ellaone contraceptive. He points out that Regulation 726/2004 does not regulate issues related to the marketing of medicinal products in a comprehensive manner. Directive 2001/83/EC of the European Parliament and of the Council, according to its Article 4 para. 4, does not affect the application of national legislation prohibiting or restricting the sale or use of medicinal products as contraceptives or abortifacients. In Poland, there is no legislation expressly establishing a ban or restrictions on marketing or application of this particular type of agents, and any possible national legislation introduced to implement the restrictions permitted under the Directive should not only aim at eliminating the effect of the decision of the European Commission amending marketing authorisation issued by a decision (2009) 4049 for “ellaOne – ulipristal acetate”, a medicinal product for human use, but should relate to this category of products.