Arnold & Porter Kaye Scholer LLP (LexBlog Ireland)
4 results for Arnold & Porter Kaye Scholer LLP (LexBlog Ireland)
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The Windsor Agreement and supply of medicinal products in Northern Ireland
On 27 February 2023, an agreement in principle was reached by the UK and EU, known as the Windsor Agreement, relating to post-Brexit trade issues in Northern Ireland (NI). The principles are expected to be approved shortly by the EU-UK Joint Committee. The UK Government and the EU institutions will then enact legislative measures to...
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Brexit update: Supply of Medicines from Great Britain to Northern Ireland
As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great Britain (“GB”) now has a freestanding independent regulatory regime. This means that there are two sets...
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Food Standards Agency announcement on CBD
Yesterday, the Food Standards Agency (FSA), which regulates foods and food businesses in England, Wales and Northern Ireland, issued its long-awaited statement on CBD in foods. In January 2019, the European Commission updated the Novel Food Catalogue to state that extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods,...
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Shire v EMA: European General Court provides clarification for designation of orphan medicinal products
On 22 March 2018, the European General Court handed down its judgment in Case T-80/16 Shire Pharmaceuticals Ireland v EMA. Shire had sought annulment of the EMA’s decision refusing to validate its 2015 application for designation of its medicinal product Indursulfase-IT as an orphan medicinal product for the treatment of Hunter Syndrome. This decision is...