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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.

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.

The Canary Islands Government has decided to reduce the tax rate applicable to different goods and services including medical devices, veterinary medicines and veterinary services. These changes are expected to facilitate patients’ access to these products and services by reducing their costs.

The use of telemedicine in Spain has increased in recent years, and although there is currently no national regulation in this regard, it is possible to find sectoral provisions that provide guidance for its practice. In this sense, the companies that engage in telemedicine must take into account the legal implications that may affect them, such as data protection or the treatment of patient information.

The Ministry of Health has issued a note in which it promotes the use of QR codes to show the technical data sheet of medicinal products in promotional materials aimed at healthcare professionals. However, some information must remain in physical format to comply with the regulations on the advertising of medicinal products.

The Spanish National Court annulled the evaluation system of newly approved medicinal products set up in 2020 by the Spanish Ministry of Health because the system was created without following the legally established procedure and was approved by a body that did not have the authority to do so. The court states that the Therapeutic Positioning Reports cannot be considered as a mandatory instrument for the evaluation of medicines prior to the financing decision and clarifies that the Spanish Agency of Medicines and Medical Devices has the exclusive competence to issue such reports. The annulment of the Plan is expected to shorten the timeframe for financing new medicinal products.

A modification of the current fertiliser products regulation (Royal Decree 529/2023) has been published. This new Royal Decree 529/2023 improves the alignment of national regulations with Regulation (EU) 2019/1009 on EU fertiliser products to avoid tensions between these two regimes. The new regulation introduces provisions on certain mixtures of micronutrients, inorganic fertilisers based on ammonium nitrate and the criteria that sub-products must meet in order to be classified as such.

The Spanish Government has approved a new Royal Decree 666/2023 completing the regulatory framework for veterinary medicinal products. This regulation seeks to update the regulations governing veterinary medicinal products in accordance with current scientific advances and economic conditions. Among other considerations, it aims to improve the protection of animal health, the environment and the public health.

“Communication 1/2023, of 13 June on the criteria that shall govern the prohibition for companies that distort competition to enter into contracts with the public sector by the National Commission for Markets and Competition” (the “Communication”) has been approved. The Communication sets out the criteria that will guide the CNMC when determining the prohibition to contract with the Public Sector and the scope of the prohibition. The CNMC will follow the criteria set out in the Communication in its future infringement decisions.

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.