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Product Regulation & Liability

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The Subsecretary of Open Government and Digital Country, dependent on the Chief of Cabinet of Ministers), created the Vacunación COVID-19 database by means of Disposition No. 06/2021, published in the Official Gazette on 21 April 2021. Its purpose is to organize, accelerate and make effective the administration of vaccines authorized by the competent entities and jurisdictions against COVID-19, contributing to the prevention of the virus and the limitation of its health consequences.

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.

With judgment No. 4816 of 26 April 2021, the Administrative Court ruled on an appeal for the annulment of the final award of a Framework Agreement for the supply to public hospitals of digital mammography devices, related services, equipment and optional services. The appellant claimed that the successful bidder should have been excluded for the tender procedure for having unlawfully used a continuous cooperation agreement, pursuant to art. 105, paragraph 3, letter c-bis), of the Code of public contracts.