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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
