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On 23 January 2024, the European Medicines Agency published an updated version of the user guide for micro, small and medium-sized enterprises in the pharmaceutical sector. The revised guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorization of medicines for human and veterinary use.

With Decree of 29 December 2023, published on 9 February 2024, the Ministry of Health identified the criteria and procedures for the payment of the annual fees for the monitoring and management of the Fund for the Governance of Medical Devices referred to in Article 28 of Legislative Decree No. 137/2022.

On 23 January 2024, the European Commission published a proposal to amend Regulation 2017/745 (EU) on Medical Devices and Regulation (MDR) 2017/746 (EU) on In Vitro Diagnostic Medical Devices (IVDR), which regulate notification requirements in the event of an interruption in the supply of certain types of medical devices and in vitro diagnostic medical devices, the introduction of Eudamed as a tool for the diffusion of information on devices available on the EU market, as well as transitional provisions for in vitro diagnostic medical devices.

In order to set the regulatory framework for a products containing cannabis, the Ministry of Health has launched a public consultation on a draft Royal Decree establishing the conditions for the preparation and dispensing of magistral formula based on standardized preparations of these substances. In this regard, the interested parties were able to present allegations until 4 March 2024.

On 13 February 2024, the FCA issued a Final Notice to Floris Jakobus Huisamen, the former director and compliance officer of London Capital & Finance plc (LCF), fining him GBP 31,800 and banning him from working in financial services in relation to misconduct connected to financial promotions issued by LCF. This Final Notice follows the FCA’s previous censure of LCF in October 2023 for connected behaviour. In this alert we draw out the key takeaways that compliance officers should bear in mind from the FCA’s enforcement action.

The autonomous region’s tranche of the Special Tax on Hydrocarbons in force in Spain between 2013 and 2018 was contrary to the EU Energy Taxation Directive and should therefore be declared unlawful, as concluded by the Advocate General of the Court of Justice of the European Union, Athanasios Rantos.

At the end of last year, the Belgian Parliament adopted a new Program law, which includes new rules on the controlled foreign company regime in Belgium applicable as of tax assessment year 2024.
In this webinar, we briefly explain the new rules, how they will impact you, and what the remaining uncertainties are.

On 24 January 2024, the European Commission published a package compromising five initiatives aimed at bolstering the EU’s economic security amidst growing geopolitical tensions and profound technological transformations. Central to this package is a proposal for a reform of the existing EU foreign investment review screening framework as it currently exists on the basis of Regulation (EU) 2019/452 and essentially provides for a notice-and-comment procedure in its current form.