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.
Baker McKenzie’s Sanctions Blog published the alert titled Blog Series: Sanctions Enforcement Around the World, the Spanish Perspective on 14 June 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
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.
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.
The AEMPS has published new indications on the adaptation of veterinary medicinal products to the content of Regulation (EU) 2019/6, which establishes a period of five years for veterinary medicinal products authorized under the previous legislation to adapt to the provisions of the new Regulation. For this reason, the Quality Review of Documents has been adapted to version 9.0 on the summaries of product characteristics, package leaflet and labelling of veterinary medicinal products.
Join us for a four-part webinar series as our US moderators welcome colleagues from around the globe to share the latest labor and employment law updates and trends. US-based multinational employers with business operations in Asia Pacific, Europe, the Middle East and Africa, and the Americas regions will hear directly from local practitioners on the major developments they need to know, and come away with practical tips and takeaways to implement.
The Spanish Customs Authorities have released new guidelines on provisional customs values and simplified declarations. The aim is to clarify the utilization of simplified declarations foreseen in Article 166 of the UCC due to the high number of queries from operators.