The Spanish legal framework on packaging and packaging waste that entered into force in December 2022 substantially modified the regulation of packaging and packaging waste in an effort to implement a circular economy in Spain. Most of the obligations have already entered into force. However, certain marking and information obligations will enter into force on 1 January 2025.
The Spanish Agency for Medicines and Medical Devices (AEMPS) has implemented a new system for the payment of clinical trial fees in Spain. The Application, which is available on the AEMPS website, facilitates the payment process and eliminates payment errors that existed in the previous system.
The Government of Catalonia has recently published a guide on the advertising of medicinal products for human use. This guide provides new and updated advice on the understanding of the regulations on advertising on medicinal products. In particular, it focuses on advertising in the digital environment, analyzing the use of digital platforms and tools and providing recommendations for responsible advertising in accordance with the current sectorial regulatory framework.
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.