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- The Mysteries of the Falsified Medicines Directive Where is the Logic on Safety Features
The Mysteries of the Falsified Medicines Directive Where is the Logic on Safety Features
January 27, 2015, Scrip Regulatory Affairs
January 31, 2018, Covington Alert
In the EU, a sponsor can obtain an “orphan designation” for a medicinal product pursuant to Regulation 141/2000. Adopted in December 1999, the regime aims to encourage investment in R&D for treatments for rare diseases. The most important incentive is the 10-year market exclusivity for designated products. Other incentives include protocol assistance and fee ...