On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency.  The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities.  The Guidance…
Continue Reading The Italian Medicines Agency publishes Guidance on the management of clinical trials in Italy during the COVID-19 emergency

The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year.  This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding…
Continue Reading European Commission plans to postpone the application date of the Medical Device Regulations in response to COVID-19

On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19.  The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as…
Continue Reading MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19

On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19.  The DHSC is making £500,000 available, with funding of up to £25,000 per company.  The challenge, named TechForce19, aims to increase community…
Continue Reading TechForce19: UK Government promises up to £25,000 for innovator companies that develop digital support solutions for COVID-19

On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).

The Guidance provides information on…
Continue Reading EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic

The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”).  The purpose of the RMVS Specification is to meet the…
Continue Reading MHRA issues specification for a “Rapidly Manufactured Ventilator System” for use in hospitals during the COVID-19 outbreak

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…
Continue Reading DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19

The European Commission has just adopted a Regulation that will lift the existing ban on imports of poultry meat from Ukraine that was triggered by the January 2020 Highly Pathogenic Avian Influenza (“HPAI”) outbreak in the western part of the country.

On January 19, 2020 the Ukrainian authorities informed the…
Continue Reading The EU Lifts Restrictions to Imports of Poultry Meat from Ukraine Following the Regionalization of the Country Due to an Outbreak of HPAI

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…
Continue Reading UK sets deadline for novel food authorisation of CBD products

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