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The Government of Spain has approved the creation and operating regulation of the Ultimate Beneficial Ownership Registry, by means of Royal Decree 609/2023 of 11 July 2023, which was published today in the Official State Gazette. This registry is configured as a central and public registry, through which information on ultimate beneficial ownership of Spanish legal entities and other entities or structures without legal personality can be generally accessed.

The Spanish State Gazette published yesterday contains the Royal Decree 571/2023, of 4 July, on Foreign Investments which is intended to (i) update the procedure for declaring foreign investments for statistical and information purposes (both foreign investments in Spain and Spanish investments abroad); and (ii) develop certain features of Law 19/2003, of 4 July, on the legal regime of capital movements and foreign economic transactions and its implementing regulations, particularly with regard to the introduction of Article 7bis, relating to the suspension of the liberalization regime, in order to provide greater legal certainty to the authorization procedure, for the cases in which this is meant to be mandatory.

On 29 June 2023, the Spanish Data Protection Authority (AEPD) circular on commercial phone calls (formally called “Circular 1/2023, de 26 de junio, sobre la aplicación del artículo 66.1.b) de la Ley 11/2022, de 28 de junio, General de Telecomunicaciones”) was published in the BOE (official state gazette).

At the end of June 2023, the new Royal Decree 5/2023 was published, introducing various health and social measures. Among the different legislative changes that have taken place, the most important is the modification of the Law on Guarantees and Rational Use of Medicines and Medical Devices. From now on, the autonomous communities are allowed to establish measures for dispensing medicines and medical devices remotely if there are circumstances that justify it due to the situation of the patients.

On 13-15 June 2023, the European securitization industry gathered in Barcelona for the 27th edition of the Global ABS conference. With the expansion of market products on offer and updated regulation coming into force in the near term, there is expected to be plenty of opportunities and long-term growth for securitization as a funding tool. The Baker McKenzie securitization teams across Europe have put together the following ‘key takeaways’, based on our discussions with market participants, general sentiment and some excellent panel sessions.

The new Royal Decree 3/2023 has been published, which establishes the technical-sanitary criteria for the quality of drinking water as well as its control and supply. In this way, the European regulations have been transposed to the national level, with the main goal of improving health protection against the contamination of water intended for human consumption, regardless of its final purpose.

The AEMPS (Spanish Medicines and Medical Devices Agency) has published new guidelines on how conduct clinical investigations with medical devices, in order to adapt them to the EU Regulation 2017/745. The main changes include adjustments regarding the requirements for approval of clinical investigations, modifications to the procedures and deadlines and the documentation required.