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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.

Priority review Guidance Pharmaceuticals
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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.

Priority review Guidance Pharmaceuticals
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AGCM Investigates Procter & Gamble for Misleading Braun Ads

The Italian Competition Authority (AGCM) has launched an investigation into Procter & Gamble S.r.l. concerning misleading advertising for the Braun Skin i-Expert hair removal device. The authority is concerned that claims of being 'hair-free for two years' may overstate the product's effectiveness and lack sufficient evidence.

Priority review Enforcement Consumer Protection
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Italian Competition Authority Investigates Ambush Marketing for Milan-Cortina 2026

The Italian Competition Authority has launched two investigations and one moral suasion action against supermarket chains Rialto (Il Gigante), MD S.p.A. (MD), and SELEX Gruppo Commerciale S.p.A. (Famila) for alleged ambush marketing related to the Milan-Cortina 2026 Olympic and Paralympic Winter Games. The actions are based on potential breaches of Article 10 of Law Decree No. 16/2020.

Priority review Enforcement Antitrust & Competition
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Italian Competition Authority Fines Bernabei Companies for Unfair Commercial Practice

The Italian Competition Authority has fined Bernabei s.r.l. and Bernabei Liquori s.r.l. a total of €400,000 for unfair commercial practices. The companies made misleading claims and omitted key information regarding discounts on alcoholic and non-alcoholic drinks advertised on their website and app.

Priority review Enforcement Consumer Protection
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Italian Competition Authority Closes FiberCop and TIM MSA Investigation

The Italian Competition Authority has closed its investigation into the Master Service Agreement between FiberCop and TIM by accepting commitments from the companies. The investigation, opened in December 2024, focused on exclusivity clauses, rebate schemes, and IRU transfer terms. The accepted commitments aim to ensure effective competition and maintain incentives for future investments in fibre infrastructure.

Priority review Enforcement Antitrust & Competition
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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.

Priority review Enforcement Antitrust & Competition
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Italy Reciprocates Austrian Macroprudential Measure

The Bank of Italy has decided to reciprocate Austria's macroprudential measure, a 1% sectoral systemic risk buffer on exposures to construction and real estate sectors. This measure, effective April 1, 2026, applies to Italian banks and banking groups, with an exemption for institutions with exposures below €100 million.

Priority review Notice Banking
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Eurocoin Indicator Shows Slight Fall in January

Banca d'Italia announced that the Eurocoin indicator, a measure of euro area economic activity, slightly decreased to 0.49 in January 2026 from 0.52 in December 2025. This indicates a continued, albeit softened, phase of cyclical expansion within the euro area.

Routine Notice Financial Services
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ECB Banking Data: Assets and Non-Performing Loans Ratio Increase

The European Central Bank (ECB) has published consolidated banking data for the end of September 2025. The data shows a 0.95% increase in total assets to €33.44 trillion and a 0.01 percentage point increase in the non-performing loans ratio to 1.97%.

Routine Notice Banking

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