欧洲各国药品使用说明书数据管理系统.pdf

SmPC and PIL databases in national languages in Enlarged Europe Nada Tržan-Herman, Lek d.d., Verovskova 57, 1526 Ljubljana, Slovenia e-mail: nada.trzanh@lek.si Milan Pukšič, JZZ-Pharmacy of Maribor Minařikova ulica 6, 2000 Maribor, Slovenia e-mail: info@ Introduction The paper presents two essential documents which are parts of each medicinal product registration application and the contents must be approved by the competent authority; these two documents are Summary of product characteristics-SmPC and patient information leaflet – PIL. They are enforced by EC Directives to be public available in national languages via Internet. A short survey was carried out in ten enlarged European countries showing the status of SmPCs and PILs access in printed and electronic (Internet) version. 1. European Community (EC) countries – information society and e-health Europe’s drive for dynamic knowledge-based information society and its Treaty obligation to ensure a high-level health protection are complementary goals. Health –related information is among the most sought after on the Internet. At the Feira European Council in June 2000, Member States endorsed the-Europe 2002 Action Plan which under, “health online” urges the member States to develop an infrastructure of user friendly systems for health education, disease prevention and medical care. The new information technology provides a great opportunity to European citizens to play a more active role in managing their health, and improving overall quality of healthcare. The Community should take into account the right of patients to receive simple, clear and scientifically sound information about their illness, available treatments and ways of improving their quality of life. (1) The information society is going to change the role of health care professionals, too. The implementation of pharmaceutical care demands compilation of pharmaceutical knowledge with finding high quality drug information.