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Italy: EU Directive on Whistleblowing implemented

by and 6 Mins Read

On March 15, the Law Decree No. 24/2023 (so-called “Whistleblowing” decree) has been published in the Italian Official Gazette. The decree enhances the principles of transparency and accountability in reporting and applies to all private companies that (i) employ an average of more than 50 employees or (ii), regardless of the number of employees, are active in sectors deemed particularly “sensitive” or (iii) already have in place an Organizational Model for the prevention of crimes (so-called “231” model). The new decree introduces the obligation to set up adequate reporting channels and whistleblower protection systems.

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In Product Regulation & Liability

Italy: Omnibus Directive implemented

by and 3 Mins Read

On 18 March 2023, Legislative Decree No. 26 of 2023 implementing EU Directive 2019/2161 was published in the Italian Official Journal.
After a long implementation process, the legislative decree will enter into force on 2 April 2023, amending and integrating the text of Legislative Decree no. 206 of 2005.
The new rules are intended to strengthen consumer protection when contracting, especially online, with traders. The new rules are also intended to fully harmonize consumer protection rules at European level by introducing greater transparency and more effective sanctions with regard to unfair commercial practices, unfair terms and distance contracts.

In ESG

European Union: Commission tables proposal for Green Claims Directive

by 6 Mins Read

On 22 March 2023, the European Commission tabled a proposal for a Directive on substantiation and communication of explicit environmental claims.
The proposal aims to harmonize the evaluation and monitoring of voluntary environmental claims – often referred to as “green claims” – towards EU consumers and control the proliferation of public and private environmental labels. Complementing the March 2022 proposal for a Directive on empowering consumers for the green transition as a lex specialis by providing more specific requirements on the substantiation, communication and verification of green claims, it contributes to the fight against “greenwashing”.

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In Product Regulation & Liability

European Union: Recommendations for the conduct of decentralized clinical trials

by 2 Mins Read

On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency, with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.

In Product Regulation & Liability

Italy: AIFA updates Active Substance Master File submission procedures

by 1 Min Read

On 23 December 2022, the Italian Medicines Agency (AIFA) published on its website an update concerning the procedures for submitting the Active Substance Master File, which is the document that the manufacturer of the active ingredient is required to submit to AIFA for the active substances contained in the medicine for which a marketing authorization has been applied for.

In Product Regulation & Liability

Italy: Payback on medical devices – Extension of the payment deadline

by 1 Min Read

On 11 January 2023, Decree Law No. 4 on “Urgent provisions regarding the procedures for the repayment of the medical device expenditure ceiling overrun” was published in the Italian Official Gazette. Article 1 of the Decree extends to 30 April 2023 the deadline by which companies that supplied medical devices to NHS during the years 2015-2018 must pay the required payback amounts.

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