COVID-19 vaccine production: The European Commission issues a comfort letter on cooperation between companies in the supply chain
On March 25, 2021, the European Commission (hereinafter, the “Commission”) issued a “comfort letter” on the compliance of the “Matchmaking Event – Towards COVID-19 vaccines upscale production” (hereinafter, the “Matchmaking Event” or the “Event”) with EU competition law.
EU and the Digital Green Certificate: New challenges and opportunities during the COVID-19 pandemic
On March 17, 2021, the European Commission presented a proposal to create a Digital Green Certificate to facilitate the free movement of citizens within Member States during the COVID-19 pandemic while ensuring public health safety.
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
COVID-19: Transparency mechanism in the export of COVID-19 vaccines outside EU
Due to persistent delays in deliveries of vaccines to the EU, on March 11, 2021 the European Commission adopted the new Implementing Regulation (EU) 2021/442, renewing, with amendments, through the end of June, the transparency and authorization mechanism for COVID-19 vaccine exports.