Katharina Ewert

Katharina Ewert

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UK sets deadline for novel food authorisation of CBD products

The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications.  After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other … Continue Reading

The CJEU clarifies the test to determine when a general, non-specific health claim is “accompanied” by a specific health claim

Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists. In Case C-524/18, Dr. Willmar … Continue Reading

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001. PTC Therapeutics International Limited (“PTC”) had argued before the General Court that … Continue Reading

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance).  This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to … Continue Reading

European Commission publishes Letter on Exemption allowing for UK Batch Testing post-Brexit

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here).  The letter seeks to address concerns that a number of pharmaceutical companies will not have been able … Continue Reading

UK Government Issues “No Deal” Brexit Notices for the Food & Beverage Sector

Over the past months, the Government has regularly  posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019.  The UK Government has now published four notices … Continue Reading
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