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.
In April, Royal Decree-Law 7 of 27 April 2021 was passed. It introduced major amendments to Royal Legislative Decree 1 of 16 November 2007, approving the revised text of the General Consumer and User Protection Act and other supplementary acts, which we analysed in our May newsletter.
On 30 July 2021, the Official Journal of the European Union published the Commission Implementing Regulation (EU) 2021/1248 of 29 of July 2021, as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (“Implementing Regulation”). The Implementing Regulation applies to holders of manufacturing authorizations performing wholesale distribution of veterinary medicinal products covered by that manufacturing authorization, and to holders of a wholesale distribution authorization, including those established or operating under specific customs regimes, such as free zones or customs warehouses.
The Spanish Ministry of Health has adopted a new draft of the Royal Decree on Industrially Manufactured Veterinary Medicinal Products (“Royal Decree on Industrially Manufactured Veterinary Medicinal Products”). The new draft establishes specific provisions for the application in Spain of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (“Regulation 2019/6”), which, together with Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, represents the legislative framework adopted in the middle of the European One Health Action Plan against antimicrobial resistance.
On 14 July 2021, the Spanish Ministry for Health, Consumer Affairs and Social Welfare (Ministerio de Sanidad, Consumo y Bienestar SociaI) published the draft of the new Reference Price Order. The ministry must update the reference price of the medicinal products annually. This new draft updates the reference prices set forth in the previous orders, establishes new groups and removes those that do not meet all of the applicable requirements due to supervening causes. To be included in a specific reference group, medicinal products must have the same Level 5 ATC code and an identical administration route. Interested parties have 15 days to allege what they deemed convenient for their best interests. The deadline is 4 August 2021.
On 20 January, 2021, part of Law 18/2020 of 28 December to facilitate economic activity, enters into force, following publication in the Official Gazette of the Government of Catalonia on 31 December. The main aim of this law is to facilitate economic activity in an all-digital environment, allowing for a more agile, efficient relationship between the administration and companies, supposedly with fewer administrative burdens for companies, and a more simplified administrative intervention framework.
Royal Decree-Law 36/2020 of 30 December 2020, establishing urgent measures to modernize the public administration and implement the government’s recovery, transformation and resilience plan (“RDL of Modernization”) was published on the last day of 2020 and entered into force on 1 January 2021.