4
Dec 19
Under what circumstances may an incumbent associate with a competitor in a public tender? The ICA provides useful guidance in the field of plasma derivatives.
In January 2018, the Italian Competition Authority (AGCM, or “ICA”) launched an investigation for a possible breach of Article 101 TFEU against two international manufacturers of blood-based pharmaceuticals – Kedrion S.p.A (“Kedrion”) and Grifols Italia S.p.A (“Grifols”) – for participating as a joint venture in a public tender (issued by a contracting authority acting on behalf of a group Italian regions, “Intercent-ER”) to collect blood and plasma, to produce plasma derivatives and to deliver these to the Italian National Health System (NHS).
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.
24
Oct 19
Ban on the marketing of Cannabis sativa L and its derivatives for recreational use: the ruling of the Unified Divisions of the Supreme Court of Cassation
With Judgment no. 30475 of July 10th, 2019, the Unified Divisions of the Supreme Court of Cassation stated that the marketing of Cannabis sativa L and its derivates (leaves, inflorescences, oil and resin) to the public for recreational use is unlawful unless those derivatives are, in practice, devoid of any doping or psychotropic effect.
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.
17
Oct 19
The ranitidine case: a test for the new class action?
On September 20, 2019, the Italian Medicines Agency (AIFA) ordered the withdrawal of several batches of medicine containing Ranitidine, which is produced by the pharmaceutical laboratory SARACA LABORATORIES LTD in India.
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”).
