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2 Feb 23
Transparency and responsibility regarding medical-scientific information on the web
On September 28, two international pharmaceutical industry associations, the IFPMA and the EFPIA, published a Joint Note for Guidance on social media and digital channels to guide the work of pharmaceutical companies that use the web to provide doctors and patients with information about their products and the illnesses they are intended to treat.
2 Feb 23
Register of Observational Studies: AIFA announces activation as of January 31, 2023
In a recent press release published on its website, the AIFA announced that as of January 31 the Register of Observational Studies (“RSO”) will be active and accessible through the AIFA online services portal — as is already the case for interventional pharmacological studies and the related OsSC portal.
2 Feb 23
The CJEU rules on the legality of a national law prohibiting medicinal product advertising to the general public that uses price to induce consumers to purchase
In the recent judgment of December 22, 2022 in Case C-530/20, the CJEU ruled that European law and in particular Directive 2001/83/EC are compatible with a national law that prohibits advertising even unidentified medicinal products if the advertising message encourages the purchase of the products by leveraging pricing, promotional offers, discounts, and combined sales with other products, medicinal or otherwise (including at discounted prices).
2 Feb 23
New decrees for the reorganization of ethics committees have been signed: The last fundamental steps for operation of the CTR in Italy
On January 30, the Ministry of Health finally signed four ministerial decrees that mark fundamental turning points in the construction of a regulatory framework for the European Clinical Trials Regulation (“CTR”) to become operations.
<!--:it-->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 procedure and (iii) regulate the transitional period for evaluation activities<!--:-->
31 Jan 23
How Covid changed telemedicine in Italy: Current status and next steps
In Italy, the Covid-19 pandemic rapidly accelerated implementation of telemedicine, which then was named one of the top priorities in the National Recovery and Resilience Plan. Mission No. 6 of that plan (Health) earmarks EUR 1 billion for the development of telemedicine to provide healthcare locally.
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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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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