During the Council of Ministers of 28 March 2023 the Government adopted a Law Decree on “Urgent measures to support families and companies in the purchase of electricity and natural gas, as well as on health and tax compliance”, which has not yet been published in the Official Gazette, introducing new measures on the payback for medical devices.
In a circular letter sent to the Regional and Autonomous Provinces Health Departments on 27 March 2023, the Ministry of Health clarified that the marketing authorizations holders directly engaged in the distribution of their medicinal products are required to obtain a distribution license under Article 100 of Legislative Decree 219/2006.
On 28 February 2023, the Italian Medicines Agency published on its website the updated version of the “Simplified Pricing and Reimbursement Procedure for Generic and Biosimilar Drugs”.
On 27 February 2023, the EMA announced the launch of a pilot project for the benefit of small and medium-sized enterprises aimed at providing scientific advice on clinical development strategy and clinical investigation proposals for class III medical devices and class IIb active devices intended to administer or remove medicines.
With judgment No. 2434, published on 8 March 2023, the Council of State upheld the appeal against the AIFA’s decision ordering the withdrawal from the market of a homeopathic drug on the basis of a discrepancy between the drug identified in the MA renewal application and the one actually marketed.
On 20 March 2023, Regulation EU 2023/607 was published in the Official Journal of the European Union, amending the transitional provisions of Regulations EU 2017/745 on medical devices and 2017/746 on in vitro diagnostic medical devices.