Portolano Cavallo

Life Sciences


Portolano Cavallo Life Sciences Blog
21 Sep
Whistleblowing Decree: Key points for the pharmaceutical sector
Large multinational companies are being called to assess the compatibility of existing reporting channels with the requirements of the new regulation published on March 15, 2023 on the Official Journal of the Italian Republic, implementing the EU Directive 2019/1937 on whistleblowing.
18 Sep
The new Public Procurement Code: New items, application, and transitional regime
This article is the first in the "Public Procurement Corner" series, providing updates on the new public procurement code with a focus on supplies to NHS bodies. Thanks to Antonino Iago Gentile for collaborating on this article
15 Sep
AI and machine learning in the medicine lifecycle: EMA publishes first draft of reflection paper
The first draft of EMA’s “Reflection paper” contains the authority’s latest considerations on the application of AI and machine learning methods in each phase of the medicinal product lifecycle.
14 Sep
Drug advertising: New rules on advertising for over-the-counter and non-prescription medicines (OTC and SOP)
The Italian Ministry of Health updated the guidelines regulating the use of media to publish advertising messages regarding OTC and SOP: a good step in terms of streamlining and simplification of the applicable regulatory framework. Thanks to Denise Moretti for collaborating on this article
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.

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 ...
June 30, 2023
Payback for medical devices: on June 28 Italian parliament approved the Law which, among other things, extends the deadline for the payment of the amount reduced by 52% from June 30th to Jul...
June 20, 2023
Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, i...
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