Selected aspects of europeization of pharmaceutical law.
As one of its aspects, the process of European integration has an influence on the legal orders of the Member States, which is often referred to in the literature as the europeization of law. Upon Poland's accession to the structures of the European Union, there have also been radical changes to the Polish legal system. According to the concept of the sources of law in the Polish Constitution and to the judicial decisions of the European Court of Justice, Community law now takes priority over national law, even over acts of parliament. Pharmaceutical law represents one of the areas where the harmonization process has been taking place. It shapes the principles and the manner according to which medicinal products are approved for marketing, the conditions of clinical trials, as well as the conditions of drug manufacture and advertisement. It also determines the rules of trading in medicinal products, the running of pharmaceutical wholesalers and pharmacies, as well as the duties and rights of the Pharmaceutical Inspectorate. This paper provides a summary of research on the impact of Community law on Polish pharmaceutical law, i.e. on the europeization process, and on the consequences of this process for the Polish pharmaceutical market and for research and development.
Zimmermann
Agnieszka
A
Medical Law Department, Medical University of Gdańsk, 15 Tuwima St., 80-210 Gdańsk, Poland. agnieszkazimmermann@amg.gda.pl
Wengler
Lubomira
L
Pawłowski
Leszek
L
D016907:Adverse Drug Reaction Reporting Systems; D000329:Advertising; D002986:Clinical Trials as Topic; D007880:Legislation, Drug; D011044:Poland