15
Apr 21
Software as Medical Device
The European Commission has published an interesting infographic showing which logical path should be followed in order to understand whether a software can be qualified as a medical device.
14
Apr 21
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.
13
Apr 21
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.
12
Apr 21
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.
12
Apr 21
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.
9
Apr 21
The “Pharmacy of Services” becomes more and more real
In recent months, under the pressure of the Covid-19 emergency, pharmacies have become more and more involved in the delivery of healthcare services to patients, in support of formal healthcare facilities and operating under the umbrella of the NHS.
