4
Dec 19
Medical Devices Regulation: transitional provisions on the validity of certificates issued under the former Directives
On May 26, 2020, the new Medical Device Regulation 2017/745/EU (“MDR”) will enter into force.
22
Oct 19
Artificial Intelligence in healthcare between opportunities and new challenges
Artificial Intelligence (AI) is becoming an increasingly important protagonist in the healthcare sector, undoubtedly gaining its place among tomorrow’s main challenges.
15
Oct 19
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”).
11
Oct 19
New criteria for the negotiation of prices for medicines
On August 1, 2019, the Ministry of Health announced the approval of a Ministerial Decree, issued in agreement with the Ministry of Economy and Finance, which sets new criteria for the price negotiation procedure between the medicine marketing authorisation holder (MAH) and the Italian Agency of Medicines (AIFA) in order to establish the price for medicines that will be reimbursed by the National Health Service (NHS).
7
Jun 19
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.
4
Jun 19
Substitutability of veterinary medicines: this is now also possible through the use of parallel imports
This is a period of profound changes in the veterinary medicines sector.
