Prawne aspekty produktów leczniczych stosowanych w populacji pediatrycznej
The Legal Aspects of Medicinal Products Applied in the Pediatric Population
Author(s): Katarzyna Miaskowska-DaszkiewiczSubject(s): Law, Constitution, Jurisprudence, International Law, Human Rights and Humanitarian Law
Published by: Naczelna Izba Lekarska
Keywords: medicinal products;pediatric population
Summary/Abstract: The paper concerns the legal requirements of medicinal products intended for the pediatric popu-lation. It includes the analysis of legal instruments providing for the safety of medicinal productsapplied in the therapy of children and young people. The line of argument concentrates on Regu-lation (EC) No 1902/2006 of December 20, 2006 on medicinal products for pediatric use andamending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC andRegulation (EC) No 726/2004. This Regulation entered into force on January 26, 2007 and is di-rectly binding in all EU Member States. The paper presents and assesses the solutions introducedby the legal act in question with respect to clinical tests on medicinal products involving minors,off-label use, the requirement to conduct clinical tests on the pediatric population, the PediatricCommittee and its power, as well as the incentive system for pharmaceutical entrepreneurs.
Journal: Medyczna Wokanda
- Issue Year: 1/2009
- Issue No: 1
- Page Range: 95-108
- Page Count: 14
- Language: Polish
