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5 Apr
Regulation (EU) 2023/607 extending CE certificates for medical devices and in vitro devices came into force
Regulation (EU) 2023/607 extended the duration of CE certificates for legacy devices and the relevant period during which such devices can be placed on the market or put into service, previously scheduled to expire on May 26, 2024.
9 Apr 21
Parallel import of medicines: New simplified AIFA procedure for negotiating price and reimbursement
On March 25, 2020, the Italian Agency of Medicines (AIFA) published a resolution on the simplified procedure for negotiating the price and reimbursement of parallel imported medicines.
17 Feb 21
New AIFA guidelines for compiling dossiers for medicine reimbursement and pricing requests effective March 1, 2021
On December 23, 2020, the Italian Agency of Medicines (Agenzia Italiana del Farmaco – the “AIFA”) issued Guidelines for the compilation of the dossier to support the request for reimbursement and pricing of a medicine (“Guidelines”), pursuant to the Ministerial Decree of August 1, 2019 (“Decree”).
1 Dec 20
Court of Justice of the European Union on cannabidiol: CBD is not a narcotic drug and marketing prohibitions must be appropriate to and strictly necessary for protecting public health
On November 19, 2020, the Court of Justice of the European Union (“CJEU”) ruled on cannabidiol (“CBD”) in case C-663/18.
8 Apr 20
COVID-19 emergency: clinical trials and early access to drugs
To address the current emergency caused by COVID-19, several initiatives have been undertaken at the regulatory level to promote and facilitate clinical trials and early access to drugs.
6 Feb 20
Stability Law 2020: news about homeopathic medicines
Stability Law 2020 (Law No. 160 of December 27, 2019) extended the period for homeopathic medicines available on the Italian market on June 6, 1995 to remain on the market, subject to the regulation provided by Article 20 of the Pharmaceutical Code (Legislative Decree No. 219 of April 24, 2006) and Article 1 (590) of Law No. 190 of December 23, 2014.
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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