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October 15, 2018, Covington Alert
On August 23, 2018, the UK Government published several technical guidance notices relating to the regulation of medicines and medical devices in the event of a “no deal” or “hard” Brexit, i.e., a scenario where the EU and UK fail to conclude a withdrawal agreement and an associated transitional period and where the UK becomes a “third country” from midnight CET ...
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 ...