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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,...

  • 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...

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