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Francesca R. Baratta

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

The Italian Medicines Agency has summarized the distribution methods that can be applied in the event of shortages of drugs included in transparency lists. These measures can be implemented in order to guarantee pharmaceutical assistance at the regional level, avoid charges to citizens and optimize economic resources.

The EU Court of Justice, in its judgment given in Case C-291/22 P, annulled the European Medicines’s decision denying marketing authorization for a drug, finding that the evaluation process was vitiated by the presence within the Committee for Medicinal Products for Human Use of an expert who was in a situation of conflict of interest.

On 31 January 2024, the Italian Medicines Agency (AIFA) published the Guidelines on applications for marketing authorizations submitted through the national procedure. The purpose of the Guidelines is to provide detailed information about (i) the correct submission of applications for marketing authorization and the relevant administrative and technical documentation, (ii) the steps and timeframes for the AIFA’s assessment of such applications, including any requests for clarification and/or further documentation, and (iii) the publication of the results of the preliminary assessment, the procedures for issuing the final resolutions as well as for their notification and publication in the Official Gazette.

On 23 January 2024, the European Medicines Agency published an updated version of the user guide for micro, small and medium-sized enterprises in the pharmaceutical sector. The revised guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorization of medicines for human and veterinary use.

With Decree of 29 December 2023, published on 9 February 2024, the Ministry of Health identified the criteria and procedures for the payment of the annual fees for the monitoring and management of the Fund for the Governance of Medical Devices referred to in Article 28 of Legislative Decree No. 137/2022.

On 23 January 2024, the European Commission published a proposal to amend Regulation 2017/745 (EU) on Medical Devices and Regulation (MDR) 2017/746 (EU) on In Vitro Diagnostic Medical Devices (IVDR), which regulate notification requirements in the event of an interruption in the supply of certain types of medical devices and in vitro diagnostic medical devices, the introduction of Eudamed as a tool for the diffusion of information on devices available on the EU market, as well as transitional provisions for in vitro diagnostic medical devices.

On 10 January 2024, the National Anti-Corruption Authority published some transitional indications on the application of the provisions of the New Public Procurement Code concerning the digitization of direct awarding for an amount of less than EUR 5,000.
This tool is a transitional and supplementary measure that can be adopted in case it is impossible or difficult to use the Certified Digital Procurement Platforms and does not exempt the contracting authority from the duty to transmit the relevant information to the National Public Contracts Database.

On 15 January 2024, the Decree of the Minister of Health No. 3 of 8 January 2024 on “Changes to the regulation on the organization and functioning of the Italian Medicines Agency” was published in the Official Gazette. The Decree will enter into force on 30 January 2024. The Decree provides, amongst other things, for the abolition of the role of General Director (while the position of the President as the body and legal representative of the Agency is maintained) and the creation of the management positions of the Administrative Director and the Technical-Scientific Director.