1
Dec 20
Botanical health claims: Clarification from the Court of Justice of the European Union
On September 10, 2020, the Court of Justice of the European Union (“CJEU”) ruled on health claims referencing the effects of plant or herbal substances, commonly known as botanical substances (“Botanicals”), in case C-363/19.
1
Dec 20
Toward the digital transformation in healthcare: The Garante’s FAQs on electronic health record and online reports
In recent months, the Italian Data Protection Authority (“Garante”) has again addressed the implementation of technological solutions in the healthcare sector.
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.
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.
15
Oct 20
EMA launches public consultation on the draft Guideline concerning registry-based studies
Last September, the EMA published its draft Guideline on registry-based studies (“Guideline”). This draft Guideline is currently open for public consultation: stakeholders may post comments until December 31, 2020.
15
Oct 20
Clinical trials: new rules for conflict of interests
The regulation on conflict of interest in clinical trials was recently amended by Article 11-bis of Law Decree No. 34 of May 19, 2020 (Decreto Rilancio), as amended by Law No. 77 of July 17, 2020.
