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Portolano Cavallo Life Sciences Blog  / Administrative Law
18 Sep 23
The new Public Procurement Code: New items, application, and transitional regime
This article is the first in the "Public Procurement Corner" series, providing updates on the new public procurement code with a focus on supplies to NHS bodies. Thanks to Antonino Iago Gentile for collaborating on this article
21 Feb 21
No competitive procedures are needed to execute research agreements with public entities: The Italian administrative court of last instance overturns the TAR decision
The Italian administrative court of last instance (“Consiglio di Stato”) closed litigation undertaken by Technogenetics S.r.l. that challenged a research agreement entered into by DiaSorin S.p.A. and the Pavia Hospital (which is classified, under Italian law, as a scientific research and healthcare facility, or IRCCS) for the evaluation of certain molecular and serological tests to diagnose COVID-19 (the Consiglio di Stato’s judgement was published on December 17, 2020).
16 Dec 19
Regional Administrative Court of Tuscany: recent judgment on biosimilars
n November 26, 2019, the Regional Administrative Court of Tuscany (Tribunale Amministrativo Regionale – “T.A.R.”, “Court”) ruled on the request for the invalidation of the Regional Council of Tuscany Resolution No. 457/2019 (“Resolution”) concerning the procedures for the supply and use of biosimilars in Tuscany.
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).
3 Apr 19
Italian administrative court judgments on biosimilars
In the past two months, the Italian administrative courts issued two judgments on biosimilars that substantially confirmed the previous case law on the relevant subjects.
1 Oct 17
The Consiglio di Stato rules Italian regions cannot introduce restrictions to the prescription of innovative drugs
The Italian administrative court of last instance (“Consiglio di Stato”), in its recent ruling no. 4546 of 29 September, 2017, stated that Italian regions cannot issue recommendations to limit the prescription of innovative drugs compared to those established by the Italian Agency for Medicines (the “AIFA”).
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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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