In April 2025, Italy’s competition authority (AGCM) launched an investigation into a clothing retailer over alleged unfair commercial practices. The company is accused of using dual-price tags—featuring a crossed-out higher price—to allegedly suggest discounts on items that were never actually sold at the inflated price. This potentially misleading tactic could deceive consumers into believing they are receiving a bargain.
On 21 August 2024, the Italian Medicine Agency issued the Guidelines on the matter of Regulatory Simplification and Decentralization for the Purpose of Conducting Clinical Trials of Medicinal Products in Accordance with Regulation (EU) No. 536/2014.
With determination No. 425 of 8 August 2024, the Italian Medicine Agency approved the new Guidelines for the Classification and Conduct of Observational Studies, implementing the provisions of Article 6(3) of the Ministerial Decree dated 30 November 2021.
The Italian Competition Authority (AGCM) has opened two investigations (PS12793 and PS12805) against two major luxury groups for alleged conduct in violation of Consumer Code rules in the promotion and sale of clothing items and accessories.
The Italian Competition Authority (AGCM) has opened two investigations (PS12793 and PS12805) against two major luxury groups for alleged conduct in violation of Consumer Code rules in the promotion and sale of clothing items and accessories. According to the AGCM, in both cases, the companies may have made, in promoting their products, untrue ethical and social responsibility statements, particularly regarding working conditions and compliance with legal requirements at their suppliers.
In a statement published on 18 June 2024, the European Medicines Agency (EMA) called on marketing authorization holders (MAHs) to adopt a Medicines Shortage Prevention Plan to reduce and prevent possible shortages and critical issues. The purpose of such a Plan is to collect information on the product, European and international marketing, supply chain vulnerabilities, measures to prevent shortages and, where appropriate, to reduce their impact on public health, and must contain appropriate measures to address shortages and mitigate their impact on patients.
Following the public hearing held on 22 May 2024, on 22 July 2024, the Italian Constitutional Court issued two judgments (judgment No. 139/2024 and judgment No. 140/2024) to decide the various appeals concerning the legitimacy of medical device payback regulation, i.e., the system under which medical device companies are required to contribute to the coverage of the NHS deficit in the years 2015-2018.
On 10 June 2024, the Member State Coordination Group on Health Technology Assessment adopted new HTA guidance on outcomes of joint clinical assessments and reporting requirements. In particular, the guidance on outcomes for clinical assessments aims at supporting both Member States’ authorities in defining the scope of such assessments and those responsible for such assessments in reporting all the elements needed by Member States to properly conduct clinical value-added analysis of health technologies at the national level.
The Italian Competition Authority (AGCM) has opened two investigations (PS12793 and PS12805) against two major luxury groups for alleged conduct in violation of Consumer Code rules in the promotion and sale of clothing items and accessories. According to the AGCM, in both cases, the companies may have made, in promoting their products, untrue ethical and social responsibility statements, particularly regarding working conditions and compliance with legal requirements at their suppliers.
On 3 May 2024, the European Medicines Agency (EMA) published new Q&As for applicants, marketing authorization holders of medicinal products, and notified bodies on the implementation of the EU Regulations on medical devices and in vitro diagnostic medical devices (i.e., EU Regulations 2017/745 and 2017/746). The new Q&As are based on the experience gained from the application of the regulations and the specific cases encountered so far, and aim at providing practical considerations on the relevant implementation, with particular reference to those products that consist of a combination of medicinal products with medical devices.