This book aims to give an overview of the European legal issues on medicinal products, starting from the development of the products all through to the selling of them. Topics such as the definition of a medicinal product and the description of important issues related to research and development are dealt with. Furthermore, the book analyses the marketing authorisation of a medicinal product, including the issues related to leaflets and packaging. In addition, the book gives an overview of the rules related to the distribution and import (in parallel) of medicines as well as the protection of innovation by means of intellectual property rights. Recent developments, such as the impact of internet and e-commerce as well as the processing of health data, are also examined. The political important issues of pricing and reimbursement of medicines is covered as well. The book ends with a chapter on the selling of medicinal products at pharmacies.
The book is written for lawyers as well as non lawyers (such as directors and marketing managers of pharmaceutical companies, officials of public authorities in health care, policy makers etc.) working or interested in the pharmaceutical sector.
With contributions from: S. Callens, F. De Visscher, L. Hombroeckx, B. Janse, A. Mencik, T. Schoors, J. ter Heerdt and A. Vijverman.
De individuele hoofdstukken zijn (nog) niet beschikbaar.