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GDPR Sanction for Roumasport S.R.L.

The National Supervisory Authority for Personal Data Processing in Romania has sanctioned Roumasport S.R.L. with a fine of 10,000 euros for violating GDPR provisions related to data security. The investigation followed a personal data security breach due to unauthorized access following cyberattacks.

GDPR Sanction for Ordonul Asistenților Medicali Neamț

The National Supervisory Authority for Personal Data Processing in Romania sanctioned Ordonul Asistenților Medicali Generaliști, Moașelor și Asistenților Medicali din România – Filiala Neamț for GDPR violations. The entity received a fine of 2,000 euros and two reprimands for issues related to video surveillance and data subject information.

Data Protection Authority Fines iHUNT TECHNOLOGY for Privacy Violations

The National Supervisory Authority for Personal Data Processing in Romania has fined S.C. iHUNT TECHNOLOGY IMPORT-EXPORT SA 20,000 lei for violating data protection laws regarding cookie consent. The investigation found that the company stored non-essential cookies without user consent.

CJEU Judgment: Online Marketplace Operator as Data Controller

The Court of Justice of the European Union ruled in Case C-492/23 that an online marketplace operator is a data controller under GDPR. The operator must identify and verify sensitive data in advertisements before publication and obtain explicit consent.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.

PRAC Recommendations on Signals - January 2026 Meeting

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in January 2026. Marketing Authorisation Holders (MAHs) for affected medicinal products are required to update product information within specified timelines.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in November 2025. Marketing Authorisation Holders (MAHs) are required to provide supplementary information or update product information based on these recommendations, with specific deadlines for certain signals.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in their October 2025 meeting. These recommendations are directly actionable by marketing authorisation holders (MAHs) for updates to product information.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed between September 29 and October 2, 2025. These recommendations are directly actionable by marketing authorisation holders (MAHs) for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs).

Italian Competition Authority Opens High-Speed Rail Market

The Italian Competition Authority has concluded an investigation into Rete Ferroviaria Italiana (RFI) by accepting binding commitments to open the high-speed rail market. These commitments ensure fair access for a third operator and amend RFI's capacity allocation rules to promote competition and passenger benefits.