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 decision of 15 April 2021, published on 19 May 2021, the Italian Data Protection Authority fined a physician for having disclosed a patient’s health data through the projection of a presentation relating to a clinical case during a congress.
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.
Following its publication in the Italian Official Gazette on 21 May 2021, the decree of the Ministry of Health authorizing the use of drugs for human use for the treatment of pets and certain animal diseases came into force.
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.
With judgment No. 12225 published on 10 May 2021, the Council of State ruled that generic warnings reported in the package leaflet of an authorized medicinal products do not exclude the manufacturer’s liability under the Consumer Code.
On 19 May 2021, the AIFA published the updated reports on the monitoring of biosimilar drugs in Italy which analyze the consumption and expenditure trends in the period from January 2019 to December 2020 and the the use of said drugs at the regional level in the period from January to December 2020. The purpose of the reports is to provide those individuals responsible for the monitoring and governance of pharmaceutical expenditure with useful information to promote the use of patent-expired medicines, assess the effectiveness of regional tenders, identify areas of intervention and, lastly, monitor the effects of the adopted policies.
On 4 May 2021, the official Italian version of the European Medical Device Nomenclature (EMDN), to be used for the registration of medical devices in the Eudamed database, was published. The EMDN has been developed on the basis of the Italian National Classification of Medical Devices due to its characteristics in terms of structure, purpose, usability and updating methodology.
On 6 April 2021, the Italian Medicines Agency (Agenzia Italiana del Farmarco or AIFA) published a document updating the requirements to be reported in the outer labelling of centralized medicinal products placed on the Italian market (so-called “Blue Box”). In this respect, it should be noted that the Blue Box is that area, marked by a blue border, included in the label of a medicinal product intended to contain specific information relevant for each Member State in whose territory the product is marketed.
In its press release No. 642 of 12 April 2021, the Italian Medicines Agency (AIFA) indicated a substantial increase of reports concerning medicinal products purchased online from unauthorized channels that were found to be falsified or illegal. The most recent cases include purchases of products with anti-cellulite activities and medicines used in the treatment of erectile dysfunctions.