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Impact of Brexit on Food and Drink Regulations
June 30, 2016, Covington Alert
Last week, the UK voted to leave the European Union in an advisory referendum. The impact of Brexit on food and drink regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest. But we have set out key considerations on this below based on two proposed models being discussed.
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 ...
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
September 21, 2016, Covington Alert
On September 21, 2016, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-592/14 European Federation for Cosmetic Ingredients v UK Secretary of State for Business. The Court has ruled that animal tests performed outside the European Union (EU) to comply with non-EU rules should not be used for the product safety assessment to gain access to ...