Marketing authorization for pharmaceutical products and the protection of submitted data / Eng Teong See. / Werner Meng ; Torsten Stein.

Problem outline (Legal and economic aspects); The "Generics" - decisions of the European court of justice of 1998 and its implications; The background of the generics decision of the ECJ; Data protection under the European pharmaceutical legislation and under Federal legislation in the USA; Some aspects of the National policy of the Federal Republic of Germany; The protection of Test Data submitted to governmental authorities: the impact of the TRIPs agreement on EC law.