The European Commission has recently issued Guidance on using the public procurement framework in the emergency situation related to the COVID-19 crisis. The Guidance is intended to highlight to Member State authorities the flexibilities available to them under the EU public procurement framework and in particular the Public Procurement
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DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19
On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers.
The Department of Education and Cabinet Office has published guidance on key
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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
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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.
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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
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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 the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being passed by UK Parliament. This latest Guidance follows on from the MHRA’s previous ‘no deal’ scenario further guidance note in January regarding medicines, medical devices and clinical trials regulation (available here).
- Legislative Background
The Medical Devices Regulations 2002 (UK MDR 2002) implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs), respectively (EU Directives) into UK law. Pursuant to the European Union (Withdrawal) Act 2018, the UK MDR 2002 will continue to apply.Continue Reading UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation
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
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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
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