Spain Archives

In Austria

European Union: DAC7 Risk Test

In March 2021, the EU approved new reporting rules in a directive known as DAC7. The directive will require the operators of online platforms for the sale of goods and certain services, to collect, verify and share data on their sellers and their transactions concluded on the online platform. EU member states have until 31 December 2022 to implement DAC7 into national law. Certain platform operators will become a reporting platform and will need to start collecting and verifying data points in compliance with the DAC7 reporting requirements. The collected data points must be reported to the tax authorities of the relevant EU member state annually.

In AML & Financial Services Regulatory

Spain: Registry opened for crypto-exchanges and custodian wallet providers

January 1, 2022 by Paula De Biase 2 Mins Read

As a consequence of Spain’s late implementation of the 5 AML Directive, the Registry of Crypto Exchanges and Custodian Wallet Providers at the Bank of Spain has only been recently activated. Since the end of October 2021, the procedure together with the necessary forms are now available at the Bank of Spain’s website to apply for registration as Exchange Providers of Virtual Currency into Fiat and Electronic Wallets Service Custodians, as provided for in the Spanish Act 10/2010, dated 28 April, on anti-money laundering and terrorism financing.

In Antitrust / Competition

Spain: New amendments to the revised text of the Spanish General Consumer and User Protection Act

November 18, 2021 by Montserrat Llopart, Elisabet Cots, Itziar Osinaga and Adria Masip 8 Mins Read

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.

In ESG

Germany: Distribution – Logistics – Sustainability | Marketing and Distributing Products Correctly

November 7, 2021 by Claire Dietz-Polte, Ulrich Ellinghaus, Joachim Frohlich, Katharina Spenner LL.M., Florian Tannen, Dr. Johannes Teichmann, Niklas Wielandt, Brigitte Estner, Dr. Andreas Neumann LL.M. and Vivien Vacha 1 Min Read

Please join us for upcoming webinars on important developments in the Consumer Goods & Retail industry. Please note that the webinar series will be held in German only

In ESG

Spain: Farmaindustria clears promotion of medicinal products awaiting a decision on public financing following judicial decision

October 31, 2021 by Montserrat Llopart and Sheila Mendez 2 Mins Read

Last June, the Superior Court of Justice of the Basque Country delivered a decision with wide repercussion with regards to advertising of medicinal products by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish trade association bringing together innovative pharmaceutical companies) against a regional Order regulating the advertising of pharmaceutical products through medical sales representatives in the context of the Basque Health System.

In Corporate Compliance

Spain: Deadline approaches for all Member States to transpose new Whistleblower Protection Directive

September 27, 2021 by Montserrat Llopart and Claudia Grau 3 Mins Read

17 December 2021 is the deadline for all Member States to transpose the new Whistleblower Protection Directive 2019/1937, which obliges businesses with over 50 employees to have a reporting channel. It should be noted that the aim of these new regulations is to exploit the potential for whistleblower protection to strengthen enforcement and set standards for strong protection against any reprisals.

In Corporate Compliance

Europe: Danske Bank judgment impacts branch-head office transactions

September 26, 2021 by Linnea Back, Philippe Gamito and Ana Royuela 9 Mins Read

On 11 March 2021, the Court of Justice of the European Union issued its ruling in case C-812/19. The case concerned the VAT treatment of the supply of services from a head office, which was part of a VAT group in Denmark, to its branch in Sweden.

In Europe

Spain: Antiseptics for skin use in the context of a surgical treatment or an injection will be treated as medicinal products

September 12, 2021 by Montserrat Llopart 3 Mins Read

On 12 August 2021, the Spanish Agency of Medicinal Products and Medical Devices published a briefing note on the new regulatory framework applicable to antiseptics intended for the disinfection of the surgical site prior to surgery or to the injection point. Said products had been regarded by the Spanish regulator as biocidal products until the publication of a Resolution dated 2 June 2021 which reclassified them as medicinal products.

In Corporate Compliance

United States: Industry Groups Continue to Criticize Commerce Department’s Proposed Supply Chain Regulations and Licensing Procedure

September 6, 2021 by Paul Amberg and Alexandre Lamy 7 Mins Read

On January 19, 2021, the US Commerce Department published an interim final rule (“Interim Rule”) to implement Executive Order 13873, “Securing the Information and Communications Technology and Services (“ICTS”) Supply Chain.” The Interim Rule was issued following the public comment period’s closure on January 10, 2021 on the proposed rules issued on November 27, 2019.

In Europe

EU: Commission implementing regulation on good distribution practice for veterinary medicinal products

August 26, 2021 by Montserrat Llopart and Elisabet Cots 5 Mins Read

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.