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Roberto Cursano

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Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

On 28 September 2021, the European Commission launched a public consultation on the proposed revision of the current EU’s general legislation on medicines for human use referred to in Directive 2001/83/EC and Regulation 726/2004 in order to ensure a future-proof and crisis-resistant medicines regulatory system.

On 18 August 2021, the Medical Device Coordination Group, composed of representatives of all Member States and chaired by a representative of the European Commission, published the guidance on procedures for the translation of labels and instructions for use, as well as the repackaging of medical devices. The guidance is intended to provide assistance to distributors and importers carrying out the above activities by clarifying the relevant requirements, pursuant to Article 16 of the Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices, respectively.

With a decision published in the EU Official Journal on 31 July 2021, the European Commission confirmed that the EU Portal and Database have achieved full functionality. This implies that Regulation (EU) No. 536/2014 on clinical trials will be applicable as of 31 January 2022, in accordance with the provisions of Article 99 of the same Regulation.

With judgment No. 5212 of 9 July 2021, the Council of State confirmed the decision of the Italian Medicine Agency whereby the latter requested a pharmaceutical company to remove from the package leaflet of an over-the-counter medicine all references to the indication concerning spastic-painful symptoms of the genitourinary tract, considering the relevant data inadequate to support such an indication.

In the context of an emergency negotiated procedure for the awarding of framework agreements for the supply of ecotomographs intended for the COVID-19 health emergency, the Council of State reiterated the obligation for the bidder to specify in its financial offer the cost of labor highlighting that the failure to comply with this requirement results in the exclusion from the tender pursuant to Sections 95, paragraph 10, and 83, paragraph 9, of the Code of Public Contracts.

With a press release dated 20 May 2021, the Italian Medicine Agency (AIFA) informed that starting from 31 May 2021 the new e-Dossier Pricing and Reimbursement portal is available on its website. The purpose of the Portal is to support the submission of pricing and reimbursement applications by allowing the preparation of the relevant dossiers in digital format.

On 17 May 2021, the Medical Device Coordination Group (MDCG) issued a notice addressed to manufacturers of in vitro diagnostic medical devices, and their authorized representatives, emphasizing the importance of continually assessing the impact of newly identified SARS-CoV-2 virus variants on the capability of those devices to ensure the safety of patients, compliance with essential requirements, a high level of performance, and overall compliance with applicable regulations.