PORTOLANO CAVALLO INFORM@ LIFE SCIENCES - Portolano Cavallo

LIFE SCIENCES

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
Clinical trials: new rules for conflict of interests
EMA launches public consultation on the draft Guideline concerning registry-based studies
The Italian Data Protection Authority publishes Frequently Asked Questions and Infographic on the Electronic Health Record
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
Ecommerce of medicines: the European Court of Justice states the applicability of certain restrictions imposed by a Member State destination of ecommerce upon a provider established in another Member State
Telemedicine: Italy’s Lombardia and Piemonte regions give the green light to televisits
Remote clinical trials: from emergency to new normal
September 2020
Life Sciences M&A trends: earnout clauses, general outlook, and a few drafting tips
July 2020
Supplementary protection certificates and Court of Justice: clarifications on the conditions for obtaining a supplementary protection certificate
June 2020
Acquisitions of companies involved in the medical devices business fall under the Italian foreign investment control
Venture Capital watch: how COVID-19 is affecting and will affect VC transactions with a specific focus on the life sciences and healthcare sectors
Masks, disinfectants, and serological tests: regulatory issues relating to products to be used in phases 2 and 3 of the emergency period

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