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In AML & Financial Services Regulatory

Spain: The new version of the UNE 19601 Standard on Management System for Criminal Compliance has been published

by and 3 Mins Read

On 24 April 2025, the revised version of UNE 19601 Standard on Management System for Criminal Compliance was published, replacing the previous version from 2017. UNE 19601 is the reference standard in Spain for implementing a criminal compliance management system and it covers the requirements of the Spanish Penal Code as well as international standards in the field.
The general approach of the initial version is maintained, although modifications have been introduced to adapt it to regulatory changes (primarily, those in the Spanish Penal Code and whistleblowing management standards) and international standards of recent years (such as ISO 37301:2021 or ISO 37002:2021).

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In Corporate Compliance

Spain: Draft Law on Transparency and Integrity of interest groups’ activities (lobbying activities)

by , and 6 Mins Read

The parliamentary process of the Draft Law on Transparency and Integrity of Lobbying Activities within the General State Administration and its institutional public sector has already begun. The initiative aims to transform the opaque perception of interest groups at the state level by imposing greater transparency obligations and recognizing them as legitimate, responsible, and open actors in influencing policy design and public decision-making. However, it remains to be seen whether the current text will undergo significant modifications during the parliamentary process.

In Product Regulation & Liability

Spain: Less than three months left to adapt packaging to the new marking obligations

by , and 4 Mins Read

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.

In Product Regulation & Liability

Spain: Update of the Catalan Guide on the advertising of medicinal products for human use

by 4 Mins Read

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 Product Regulation & Liability

Spain: New public consultation on the regulation of cannabis products

by 2 Mins Read

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.

In ESG

Spain: The Advocate General of the Court of Justice of the European Union states that the autonomous region’s Tax on Hydrocarbons is in breach of the EU Energy Taxation Directive

by and 6 Mins Read

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.

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In Product Regulation & Liability

Spain: The Canary Islands change the game rules for taxation in the healthcare sector

by , , and 4 Mins Read

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.

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Spain: 2024 is the year of consolidation of telemedicine as a result of the developments achieved in 2023

by and 4 Mins Read

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.

In Product Regulation & Liability

Spain: Green light to the use of QR codes in promotional materials aimed at healthcare professionals

by 3 Mins Read

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.

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