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Author
Syroka-Marczewska Katarzyna (Uniwersytet Warszawski)
Title
Legal Aspects of Marketing Authorization for Medicinal Products in the Territory of Poland
Prawne aspekty dopuszczenia do obrotu produktów leczniczych na terytorium Polski
Source
Przegląd Prawno-Ekonomiczny, 2017, nr 38, s. 58-74, bibliogr. 20 poz.
Review of Law, Business & Economics
Keyword
Prawo farmaceutyczne, Medycyna, Produkcja leków, Leki, Przemysł farmaceutyczny, Rynek farmaceutyczny, Warunek sine qua non
Pharmaceutical law, Medicine, Production of medicines, Drugs, Pharmaceutical industry, Pharmaceutical market, Sine qua non condition
Note
summ., streszcz.
Company

Abstract
Procedura dopuszczenia do obrotu ma na celu umożliwienie pacjentowi dostępu do produktu leczniczego, który spełnia potwierdzone naukowo standardy jakości, skuteczności terapeutycznej i bezpieczeństwa stosowania. Pozwolenie na dopuszczenie do obrotu stanowi warunek sine quo non wprowadzenia leku na rynek. Jedynie wyjątkowo dopuszczalne są sytuacje, gdy do obrotu mogą być wprowadzone produkty lecznicze nie mające pozwolenia. Podmiot odpowiedzialny, który otrzymał pozwolenie na dopuszczenie do obrotu produktu leczniczego jest zobowiązany do stworzenia systemu nadzoru nad bezpieczeństwem farmakoterapii tzw. pharmacovigilance. System ten ma na celu gromadzenie i rejestrowanie działań niepożądanych, co jest niezwykle ważne, ponieważ starannie przeprowadzona ocena profilu bezpieczeństwa leku pozwala na dostarczenie pełnej informacji o nim, co może ułatwić wybór odpowiedniego produktu leczniczego dla konkretnego pacjenta. Proces, o którym mowa powyżej trwa przez cały okres stosowania leku, gdyż w momencie pojawienia się nowych faktów ocena przydatności danego produktu leczniczego jest dokonywana ponownie. (abstrakt oryginalny)

Marketing authorisation procedure aims at ensuring that patients have access to medicinal products which meet scientifically proven quality, therapeutic efficacy and safety of use standards. Marketing authorisation constitutes a sine qua non condition for placing a medicinal product on a market. Only in extraordinary situations is trading in medicinal products which have not been granted marketing authorisation lawfully admissible. Producers of pharmaceuticals who have been granted marketing authorisation for a medicinal product, are obligated to develop a system supervising the safety of pharmacotherapy, the so called pharmacovigilance. The system collects and registers adverse reactions, which is of utmost importance as diligently performed assessment of the medicine safety profile allows providing full information on the medicine, which in turn facilitates the choice of appropriate medicinal product for a given patient. The above-mentioned process continues throughout the period of use of a medicinal product for, the moment new fact are reported, the efficacy assessment of the medicinal product in question is performed anew. (original abstract)
Accessibility
The Library of University of Economics in Katowice
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Bibliography
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ISSN
1898-2166
Language
eng
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