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Spain Regulatory Oversight

DLA Piper

Spain: Spanish Data Protection Authority Publishes Annual Report

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The Spanish Data Protection Authority (“AEPD“) has published its 2024 annual report, which includes the AEPD’s awareness-raising activities; the collaboration and inspection activities of the Spanish authorities; relevant...more

White & Case LLP

AI Watch: Global regulatory tracker - Spain

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Spain pioneers AI governance with Europe's first AI regulator (AESIA), an already active regulatory sandbox, and a draft national AI law implementing the EU AI Act. Laws/Regulations directly regulating AI (the “AI...more

White & Case LLP

Spain launches unprecedented public consultation on banking sector deal

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Spanish Ministry of Economy Launches Public Consultation on BBVA’s Public Takeover Bid for Banco Sabadell, after CNMC Approval with Commitments. On May 5, the Spanish Ministry of Economy, Commerce and Business received...more

International Lawyers Network

Data Privacy Guide - Spain

Introduction - We have compiled the main differences between the REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing...more

Hogan Lovells

New Medical Devices Regulation in Spain

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On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to the final text and knows...more

Hogan Lovells

Major regulatory changes in pharmaceutical laws and regulations in Spain for 2023

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The Annual Regulatory Plan for 2023 recently released by the Spanish Government provides for important regulatory changes and developments in the area of medicinal products, including pricing and reimbursement or health...more

White & Case LLP

Foreign direct investment reviews 2021: Spain

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Measures enacted to protect the Spanish economy against the COVID-19 crisis may persist longer than expected - The exceptional circumstances brought about by the COVID-19 outbreak led the Spanish government to enact a...more

Hogan Lovells

Draft text of new Spanish regulation on medical devices is opened for contributions

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The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more

Hogan Lovells

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

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The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more

Hogan Lovells

Spain agrees to new economic regime for orphan medicinal products

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On 3 March 2020, the Spanish Council of Ministers, based on Article 3(3) of the Spanish Regulation on Medicinal Products (RDL 1/2015), agreed on a new economic regime for orphan medicinal products. ...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Littler

Littler Global Guide - Spain - Q2 2019

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New Whistleblowing Legislation for European Union New Legislation Enacted - On April 16, 2019, the European Parliament passed a directive on the “Protection of persons reporting on breaches of Union law.” This legislation...more

Hogan Lovells

Spain: Obligation to provide the KID vs lack of obligation to provide the PID

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The European Union (the ”EU”) packaged retail and insurance-based investment products (PRIIPs) Regulation (the ”PRIIPs Regulation”) is applicable throughout the EU from 1 January 2018. ...more

Latham & Watkins LLP

Spain Reorganises its National Regulatory Authorities to Comply with EU Guidelines

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The Spanish government recently passed a draft bill for the “ rationalization and organization of the supervising regulatory bodies of the markets and the improvement of its governance” (the Draft Bill). The bill aims to...more

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