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4 May
Farmaci orfani: tensioni negoziali tra interesse pubblico e concorrenza
European Health Union: Commission publishes open public consultation on the European Health Data Space
29 Apr
European Delegation law to implement the Medical Devices Regulations
On April 23, Law No. 53 of April 22, 2021, “Delegation to the Government for the transposition of European directives and the implementation of other European Union acts,” was published in the Official Gazette (“Delegation Law”).
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022
15 Apr
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.
15 Apr
Pay-for-delay: The Court of Justice clarifies the scope of “by object” restrictions and “potential competition” in patent settlement cases
On March 25, 2021, the Court of Justice of the European Union ruled on appeal in the Lundbeck case, confirming the previous judgement of the General Court that upheld the decision of the European Commission on pharmaceutical “pay-for-delay” agreements.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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May 4, 2021
European Health Union: Commission publishes open public consultation on the European Health Data Space
April 22, 2021
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 20...
January 19, 2021
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
December 21, 2020
Telemedicine: Italian State-Regions Conference issues "National indications for the provision of telemedicine services" to implement telemedicine services in Italy
October 8, 2020
Ecommerce of medicinal products: according to the European Court of Justice, certain legislative restrictions imposed by the Member State where medicines are offered to public also apply to ...
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