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Portolano Cavallo Life Sciences Blog
19 Apr
Repackaging, the spaces of parallel trade under EU regulations on QR Code, and anti-fraud seals
EU Regulation 2016/161, which since February 2019 requires the presence of anti-fraud seals on the packaging of medicines for human use, authorizes parallel importers to repackage only in the case of failure to ensure a tamper-prevention system “equivalent” to that used in the original packaging.
19 Apr
Council of State revokes previous judgements in a medical oxygen cartel case due to omission of decisive facts and arguments in the reasoning
On February 15, 2022, Italy’s Consiglio di Stato revoked its previous rulings confirming fines levied on five companies by the Italian Competition Authority for participating in a medical oxygen cartel, as it found manifest omission of facts and reasoning in the judgements, and asked the ICA to produce a set of documents acquired during the proceedings so it can re-examine the case.
19 Apr
Electronic prescriptions: Recent updates
A note published by the Ministry of Health and the Ministry of Economy and Finance on March 3, 2022, announced that as of January 31, 2022, electronic prescriptions for drugs that are not reimbursed by the National Health System are operational in parts of the Italian territory.
19 Apr
MDCG Guidance: Notified bodies and surveillance of legacy devices
On February 16, 2022, the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745 (MDR) published a document providing guidance for appropriate surveillance regarding the transitional provisions under Article 120 of the MDR.
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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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...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
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