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Portolano Cavallo Life Sciences Blog  / Ministry of Health
15 Nov
The Consolidated Act on Rare Diseases is finally approved
After three years, Italy has finally adopted its first law on rare diseases. On November 3, 2021, the Italian Senate unanimously approved the Consolidated Act on Rare Diseases, or “Testo Unico sulle malattie rare”.
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
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22 Oct 20
Advertising condoms: No need to request prior authorization from the Ministry of Health
The rules on advertising condoms are expected to change in the next few days.
6 Feb 20
Important news regarding non-therapeutic use of cannabis: the Italian Ministry of Health finally sets limits for THC in hemp food products
After a long wait, the Italian Ministry of Health has finally identified the maximum THC amounts that can be contained in food products.
13 Dec 19
News about advertising medical devices on Facebook: updates from the Ministry of Health
On October 24, 2019, the Ministry of Health published an addendum to the guidelines on the advertising of medical devices, in vitro diagnostic medical devices and medical-surgical devices (collectively “Medical Devices” or “MD”) on Facebook (the “Guidelines”).
11 Oct 19
New criteria for the negotiation of prices for medicines
On August 1, 2019, the Ministry of Health announced the approval of a Ministerial Decree, issued in agreement with the Ministry of Economy and Finance, which sets new criteria for the price negotiation procedure between the medicine marketing authorisation holder (MAH) and the Italian Agency of Medicines (AIFA) in order to establish the price for medicines that will be reimbursed by the National Health Service (NHS).
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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October 27, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices
October 19, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
September 29, 2021
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
August 4, 2021
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
June 25, 2021
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
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