European Union

EMA Recommends Withdrawal of Levamisole Medicines

The European Medicines Agency (EMA) recommends the withdrawal of marketing authorisations for medicines containing levamisole due to the serious side effect of leukoencephalopathy. This recommendation follows an EU-wide review concluding that the benefits of these medicines no longer outweigh their risks for treating parasitic worm infections.

Levamisole withdrawn from EU market due to leukoencephalopathy risk

The EMA's PRAC has recommended the withdrawal of marketing authorisations for all medicines containing levamisole from the EU market. This decision is due to the confirmed risk of leukoencephalopathy, a serious brain side effect, where the benefits of the medicine no longer outweigh the risks for treating parasitic worm infections.

CVMP Opinions and Guidelines Update

The EMA's Committee for Veterinary Medicinal Products (CVMP) adopted positive opinions for several variations to existing veterinary medicinal products and discussed pharmacovigilance signals. These updates primarily involve product information changes based on signal management processes.

ESMA Consultation: Regulatory Standards for Post-Trade Risk Reduction Services

The European Securities and Markets Authority (ESMA) has issued a consultation paper on proposed regulatory technical standards (RTS) for post-trade risk reduction services. This consultation seeks feedback on requirements for services that aim to reduce risk for the purpose of clearing obligation exemptions under EMIR.

ESMA Draft RTS on EMIR 3 Clearing Thresholds

The European Securities and Markets Authority (ESMA) has published draft Regulatory Technical Standards (RTS) detailing new clearing thresholds under EMIR 3. These proposals aim to manage systemic risk in OTC derivative markets while minimizing compliance burdens for market participants.

AEPD Rejects TALENTO MOTOR S.L. Appeal

The Spanish Data Protection Agency (AEPD) has rejected an appeal filed by TALENTO MOTOR S.L. against a prior resolution. The appeal was deemed inadmissible due to being filed outside the legal time limit. This decision upholds the original resolution from November 23, 2025.

AI Act: Code of Practice on AI-Generated Content

The EU AI Office convened working groups and workshops to gather stakeholder feedback on a draft Code of Practice for marking and labelling AI-generated content under the AI Act. Discussions focused on disclosure obligations, marking techniques, and responsibilities across the AI value chain.

Spanish DPA Resolution on Voluntary Payment

The Spanish Data Protection Agency (AEPD) has issued a resolution initiating a sanctioning procedure against EMPRESA.1 for alleged data protection violations. The case involves a complaint regarding the improper acquisition and use of personal data for a contract. The resolution details the initial findings and the company's response.

ESMA Consultation on CCP Collateral and Investment Policy

The European Securities and Markets Authority (ESMA) has issued a consultation paper regarding guarantees as collateral for Central Counterparties (CCPs) and certain aspects of their investment policies. The consultation seeks feedback on proposed changes to the regulatory framework governing CCPs.

GDPR Fines Issued for Google Analytics Use

The Swedish Authority for Privacy Protection (IMY) has fined two companies and ordered three others to stop using Google Analytics due to non-compliance with GDPR regarding personal data transfers to the US. Fines total 12.3 million SEK.