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.
With a Report published on 21 April 2021, the Italian Medicines Agency (AIFA) made available the preliminary data relating to the Monitoring of the National and Regional Pharmaceutical Expenditure for the year 2020.
In April 2021, the Medical Devices Coordination Group published a new guidance to explain the role of safety and performance standards under the current Medical Device Directives, as well as the new Medical Device Regulation and the In Vitro Diagnostic Devices Regulation.
Following the extraordinary meeting held on 21 April 2021, the EMA’s Management Board confirmed that the clinical trial EU Portal and Database is now fully functional and on track to go live by 31 January 2022.
On 2 March 2021, the National Agency for Regional Healthcare Services (Agenas) published the Provider Verification Manual setting forth the national framework, established by the National Commission for Continuing Education, on the supervisory and verification activities performed by accreditation bodies on the compliance with Continuing Medical Education regulations by providers.
With judgment No. 1776 of 2 March 2021, the Council of State ruled that, for the purposes of participating in a public tender for the supply of medical devices to the NHS, the manufacturer based in another EU Member State is not required to register its product in the National Database of Medical Devices and specified that national provisions cannot restrict the free movement of devices already regularly placed on the EU market with the prescribed CE marking.
With the document “MDCG 2021-3 Questions and Answers on Custom-Made Devices” published on 15 March 2021, the Medical Device Coordination Group (MDCG) provided clarifications on the regulation of custom-made medical devices falling within the scope of Regulation (EU) 2017/745. The purpose of this document is to outline the differences among three different categories of seemingly similar medical devices: custom-made, adaptable and so-called patient-matched devices.
With EU Implementing Regulation 2021/442 of 11 March 2021, the European Commission introduced a new export authorization regime for COVID-19 vaccines applicable until 30 June 2021 which replaces the one initially established with EU Implementing Regulation 2021/111 of 29 January 2021. In particular, the new Implementing Regulation provides that the export outside the EU of vaccines and active substances classified with the identification codes listed therein is subject to prior authorization.