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.
5
Feb 20
Who can request authorization to advertise medicines? Answers from the AGCM
The Italian Competition Authority (hereinafter the “AGCM“) recently expressed an opinion and addressed a recommendation to the Ministry of Health (the “Ministry”) regarding the parties entitled to request authorization to advertise medicinal products to the public (resolution No. AS1628 of December 9, 2019
5
Feb 20
Class I medical device manufacturers may benefit from the transitional period under the MDR
On December 17, a corrigendum to Medical Device Regulation (MDR) 745/2017 was approved by the European Parliament that allows certain devices classified in Class I under Directive 93/42/EEC to benefit from the transitional period provided by the MDR.
17
Dec 19
EU commission publishes a new version of the draft Q&A on the application of the clinical trials regulation
In November 2019, the European Commission published a draft version of the answers to the numerous questions (“Q&A”) raised by stakeholders relating to the implementation of the rules laid down in Regulation (EU) No. 536/2014 on clinical trials.
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”).
12
Dec 19
Pharmaceutical trademarks: the proof of genuine use and proper reason for non-use
In its decision issued on 3 July 2019 in Viridis, Case C-668/17 (the “Decision”), the Court of Justice of the European Union (“CJEU”) ruled that the lengthy time necessary to complete a clinical drug trial is not a proper reason to prevent the prematurely registered trademark from being revoked for non-use.
