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.
The Spanish Registry of Food Contracts has become fully operative on 30 June 2023, which means that, as of that date, operators are obliged to register all food contracts concluded with primary producers, as well as their amendments.
As part of the EU Green Deal launched in 2019, a strong mandate has been issued to ensure consumers receive reliable, comparable and verifiable information to enable them to make more sustainable decisions and to reduce the risk of greenwashing.
The proposed European Union (EU) Green Claims Directive was tabled by the European Commission in March 2023 and aims to address greenwashing and introduces stringent requirements on various aspects in tackling false environmental claims.
The Resolution ACC/747/2023, of 6 March 2023, was published in the Diari Oficial de la Generalitat de Catalunya (the Official Gazette of the Catalan Government). Said Resolution declared the state of exceptionality due to hydrological drought in the exploitation units of the Llobregat Reservoirs, Ter Reservoirs and Ter-Llobregat Reservoirs and modified the states of hydrological and pluviometric drought of other exploitation units in Catalonia (Spain)
The publication of the July 2022 version of the European Commission’s Blue Guide on the implementation of European Union product rules aims to adapt to changes in European legislation on the marketing of products within the EU. In this sense, the aim is to improve the understanding of EU legislation and its application in the fields that make up the single market. The Guide is for guidance only, which means that it has no legal force. Among the most relevant changes are the introduction of specific sections on product repairs, software, online sales and Brexit.
The Spanish Ministry for Health, Consumer Affairs and Social Welfare have published the Draft of the Reference Price Order of 2022 with the aim of updating the reference prices set forth in previous orders, establishing new groups and removing those that do not meet the applicable requirements.
The year has ended with important new developments for companies that contract with the public sector, new developments that have come into force on January 1. Both the State and Catalan’s budgetary laws contain provisions on this matter. Also, as each year, the new thresholds applicable to harmonized contracts have been published.