11
Feb 20
Medicine and medical device e-commerce: regulatory restrictions and opportunities
More and more healthcare and pharmaceutical companies are entering the world of e-commerce.
11
Feb 20
EDPS: clarification on data protection and scientific research
On January 6, 2020, the European Data Protection Supervisor (EDPS) issued a preliminary opinion on data protection and scientific research, in which it provided clarification on the application of data protection rules established by the General Data Protection Regulation (GDPR) and Regulation No. 2018/1725 with regard to scientific research.
10
Feb 20
Early lessons from the ECJ on access to documents included in a marketing authorization dossier
On January 22, 2020, the European Court of Justice (ECJ) issued its first rulings regarding access to European Union documents submitted as part of a request for marketing authorization (MA) for medicinal products (C-175/18 P, PTC Therapeutics International v. EMA; C-178/18 P, MSD Animal Health Innovation and Intervet International v. EMA).
7
Feb 20
Traditional herbal medicinal products and nutritional supplements: criteria of distinction
With judgment No. 14408 of December 13, 2019, the Administrative Court of the Lazio Region provided clarification on the distinction between traditional herbal medicinal products and nutritional supplements.
