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- EU Financial Penalties for Centrally Approved Medicinal Products in Europe How to Prepare
EU Financial Penalties for Centrally Approved Medicinal Products in Europe - How to Prepare?
September 17, 2012, Covington Advisory
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 ...
May 8, 2016, Financial Times
Peter Bogaert and Grant Castle are quoted in a Financial Times article regarding the effect Brexit would have on the UK pharma industry. According to Bogaert, commenting on the important relationship between the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency, “Brexit would be a loss for both sides.” Castle adds that ...