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 procedure and (iii) regulate the transitional period for evaluation activities
E-commerce of medicinal products: According to the Court of Justice, a foreign pharmacy may be subject to the restrictions in force in Member States where it sells medicines online
With e-commerce becoming more and more widespread, including in the pharmaceutical sector, we are taking a close look at the small but growing number of decisions in both national and European courts that are already providing early indication and some interpretation of the many gray areas left by applicable legislation in this field.
Italian Medicines Agency and medicines shortage: published Q&A for MAHs on notification of shortage and any temporary or permanent interruption in the marketing of medicines
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).
Interruption in the marketing of medicines: AIFA provides clarifications to MAHs on their communication duty
On October 9, 2019, the Italian Medicines Agency (“AIFA”) issued an information notice to provide useful information to medicine marketing authorisation holders (“MAH(s)”) on the obligation to notify AIFA of any temporary or permanent interruption in the marketing of medicines (“AIFA Note”).
Regulations on the shortage of medicines in the Draft law converting the “Calabria” Law Decree
On May 3, 2019, Law Decree No. 35 of April 20, 2019 (the “Calabria Decree “) entered into force. The Calabria Decree includes significant provisions relating to the shortage of medicines.