On January 30, 2021, the European Commission published the Regulation establishing an export authorization and notification scheme relating to COVID-19 vaccines and their active substances. It applies “for a limited duration” to COVID-19 vaccines covered by Advanced Purchased Agreements (“APAs”) concluded with the Union. As regards APAs contracted by third countries, “the Commission will endeavour … Continue Reading
On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European Medicines Agency (EMA) and the national Heads of Medicines Agency (HMA). The Guidance is an update to the previous version published in late March (see InsideEULifeSciences blog post … Continue Reading
On 23 April 2020, the European Parliament and Council approved the European Commission’s proposal to delay the application date of the Medical Device Regulation 2017/745 (the “MDR”) by one year (from 26 May 2020 to 26 May 2021) by adopting New Regulation (EU) 2020/561 (the “New Regulation“). Unusually, the New Regulation took effect on the … Continue Reading
The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19. The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19). Applications for clinical trials of human medicines or clinical investigations of medical devices … Continue Reading
As reported previously on this blog, several member states have imposed bans, requisitioned stock and applied various other control measures on medicines and protective equipment (e.g., Belgium, Bulgaria, the Czech Republic, France, the Netherlands, and Poland). On 8 April 2020, the European Commission (“Commission”) issued Guidelines on the optimal and rational supply of medicines to … Continue Reading
The European Commission published today its proposal for the European Parliament and the Council to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year. This publication comes only 9 days after the Commission announced its plans to postpone the MDR (see the InsideEULifeSciences blog post here). The European Parliament and … Continue Reading
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 Directive 2014/24/EU. The Guidance highlights the … Continue Reading
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 is intended to ensure that … Continue Reading
