PORTOLANO CAVALLO INFORM@ LIFE SCIENCES

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April 2021
COVID-19 vaccine production: The European Commission issues a comfort letter on cooperation between companies in the supply chain
EU and the Digital Green Certificate: New challenges and opportunities during the COVID-19 pandemic
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
COVID-19: Transparency mechanism in the export of COVID-19 vaccines outside EU
The “Pharmacy of Services” becomes more and more real
Parallel import of medicines: New simplified AIFA procedure for negotiating price and reimbursement
March 2021
E-prescriptions now available also for drugs not reimbursed by the NHS
February 2021
Foreign investment control regulations: extension of COVID-19–related rules and new list and definition of strategic assets with a brief focus on the health industry
Italian Data Protection Authority approved the first code of conduct in the public sector regulating the use of health data for educational and scientific publication purposes
No competitive procedures are needed to execute research agreements with public entities: The Italian administrative court of last instance overturns the TAR decision
Telemedicine: The New National Guidelines
New AIFA guidelines for compiling dossiers for medicine reimbursement and pricing requests effective March 1, 2021
December 2020
Generic and biosimilar medicines: Italian Medicines Agency adopted a new simplified pricing and reimbursement procedure
E-commerce of medicinal products: According to the Court of Justice, a foreign pharmacy may be subject to the restrictions in force in Member States where it sells medicines online
Botanical health claims: Clarification from the Court of Justice of the European Union
Toward the digital transformation in healthcare: The Garante’s FAQs on electronic health record and online reports
Court of Justice of the European Union on cannabidiol: CBD is not a narcotic drug and marketing prohibitions must be appropriate to and strictly necessary for protecting public health
October 2020
Advertising condoms: No need to request prior authorization from the Ministry of Health
Italian Competition Authority says that the rules on the remuneration of health care services provided by pharmacies are anti-competitive
Foreign investment control in the life science sector: the scope of the Italian Government’s powers also in the context of the current COVID-19 pandemic