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1 Dec 20
Botanical health claims: Clarification from the Court of Justice of the European Union
On September 10, 2020, the Court of Justice of the European Union (“CJEU”) ruled on health claims referencing the effects of plant or herbal substances, commonly known as botanical substances (“Botanicals”), in case C-363/19.
8 Jun 20
Health Claims on Botanicals: according to the Council of State, unauthorized claims may be used if scientifically proven
With judgment No. 2371 of April 10, 2020, the Council of State (or the “Court”) provided significant clarification regarding health claims that can be used with respect to a category of food supplements made of plant materials and herbal preparations (“Botanicals”).
7 Feb 20
Traditional herbal medicinal products and nutritional supplements: criteria of distinction
With judgment No. 14408 of December 13, 2019, the Administrative Court of the Lazio Region provided clarification on the distinction between traditional herbal medicinal products and nutritional supplements.
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 news, insights 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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March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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