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On 30 March 2023, Members of the European Parliament endorsed proposed reforms to the General Product Safety Directive (GPSD) in the form of a Regulation, intended to safeguard consumers. This new Regulation looks set to be one of the most significant updates to the EU’s product regulatory landscape in modern history – making substantial amendments to the GPSD, which has been in force for more than two decades.

During the Council of Ministers of 28 March 2023 the Government adopted a Law Decree on “Urgent measures to support families and companies in the purchase of electricity and natural gas, as well as on health and tax compliance”, which has not yet been published in the Official Gazette, introducing new measures on the payback for medical devices.

In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of assigning responsibility for AI governance to a new single regulator, the UK Government is empowering existing regulators to come up with tailored approaches for specific sectors. The aim is to ensure that the UK remains a flexible and innovation-friendly jurisdiction for AI developers. The flipside is that the UK approach may leave gaps between regulators, by failing to take a more holistic approach along the lines of the EU.

In a circular letter sent to the Regional and Autonomous Provinces Health Departments on 27 March 2023, the Ministry of Health clarified that the marketing authorizations holders directly engaged in the distribution of their medicinal products are required to obtain a distribution license under Article 100 of Legislative Decree 219/2006.

On 27 February 2023, the EMA announced the launch of a pilot project for the benefit of small and medium-sized enterprises aimed at providing scientific advice on clinical development strategy and clinical investigation proposals for class III medical devices and class IIb active devices intended to administer or remove medicines.

With judgment No. 2434, published on 8 March 2023, the Council of State upheld the appeal against the AIFA’s decision ordering the withdrawal from the market of a homeopathic drug on the basis of a discrepancy between the drug identified in the MA renewal application and the one actually marketed.