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In Trade and Foreign Investment

Spain: Royal Decree on foreign investments

by 1 Min Read

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.

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Spain: New regulation on commercial calls

by 2 Mins Read

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).

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In Product Regulation & Liability

Spain: Allowing the non-presential dispensing of medicines and medical devices

by 3 Mins Read

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.

In AML & Financial Services Regulatory

Europe: Insights from Barcelona – a glimpse into Global ABS

by , , , , , , and 7 Mins Read

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.

In ESG

Spain: Technical-sanitary criteria for the quality of drinking water, its control and supply

by 4 Mins Read

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.

In Product Regulation & Liability

Spain: New instructions applicable to clinical investigations with medical devices

by 3 Mins Read

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.

In Product Regulation & Liability

Spain: New deadline for transferring Medical Device Commercialization Communications to the CCPS application.

by 4 Mins Read

The PMPS, in which commercial communications of medical devices were registered, ceased to be operational and was replaced by the new CCPS application of the AEMPS. However, communications made to the PMPS were still valid, although they cannot be managed until they are migrated to the CCPS. Consequently, the AEMPS has set the deadline of 18 July 2023 for the transfer of marketing communications to the new CCPS application, requesting companies to retrieve them by that date, updating their information and submitting them to the necessary review by the AEMPS, prior to their inclusion in CCPS.

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