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In ESG

Netherlands: ESG and Tax – Opens consultation on CSRD implementation

by 5 Mins Read

On 18 July 2023, the Dutch government published draft legislation to implement the EU’s Corporate Sustainability Reporting Directive, which was adopted on 14 December 2022 by the EU. The government has invited stakeholders and other interested parties to provide feedback on the draft bill before 10 September 2023. The draft bill requires certain companies to report on sustainability issues and addresses the audit requirements for auditors and accounting firms for the corporate sustainability report. It also expands the reporting obligations for listed companies.

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In Product Regulation & Liability

Italy: Ministerial decrees on clinical investigation applications published in the Official Journal

by 2 Mins Read

In the Official Journal of 13 June 2023, the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for devices that are not CE-marked and CE-marked but used outside their intended use and the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for CE-marked devices used within their intended use were published. These decrees are provided for in article 16, paragraphs 2 and 3 of Legislative Decree No. 137/2022 issued to bring national legislation in compliance with the provisions of Regulation (EU) 2017/745.

In Product Regulation & Liability

Italy: European Medicines Agency has updated its Q&A on good clinical practice (GCP)

by 2 Mins Read

On 23 June 2023, EMA’s GCP Inspectors Working Group updated the Q&A on Good Clinical Practices. In particular, the update has allowed for the possibility, if in compliance with applicable European regulations and the requirements of ICH E6 guideline, that the sponsor may support the investigator by identifying or contracting service providers or personnel to be directly involved in the conduct of the clinical trial (e.g., by providing additional resources to the clinical trial site or qualified personnel).

In Product Regulation & Liability

Italy: Decrees of the Ministry of Health of 20 March 2023 published in the Official Journal

by 2 Mins Read

In the Official Gazette of 14 June 2023, the Decree of the Ministry of Health of 20 March 2023 regulating the requirements of facilities suitable for conducting clinical investigations and the Decree of the Ministry of Health of 20 March 2023 introducing provisions to ensure that persons in charge of evaluating and validating clinical investigation applications do not have a conflict of interest, are independent of the sponsor, the investigators involved and the natural or legal persons financing the clinical investigation, and are free from any undue influence were published. These decrees, which are immediately applicable, are provided for in article 16, paragraphs 5 and 8 of Legislative Decree No. 137/2022.

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In Trade and Foreign Investment

European Union: National FDI regimes must respect EU fundamental right of establishment

by 5 Mins Read

On 13 July 2023, in Case C-106/22, the European Court of Justice delivered its decision in relation to a preliminary reference submitted by the Budapest High Court. In the context of companies that often have a cross-border ownership structure extending outside of the EU, the ECJ concluded that the fact that a parent company registered in a third country has a majority control over an EU-based investor does not mean that the EU FDI Screening Regulation applies.

In Tax

United Kingdom: What of significance did we get on Tax Legislation Day?

by 8 Mins Read

On 18 July 2023, HM Treasury and HMRC published draft tax legislation for inclusion in the Finance Bill 2024 and certain policy papers. The draft legislation is open for technical consultation until 12 September 2023. Finance Bill 2024 is expected to be introduced to Parliament in Autumn 2023 and to receive Royal Assent in Spring 2024.

In

Italy: Employment law alert – Breaking news

by , and 2 Mins Read

On 15 July 2023 the Italian National Anti-Corruption Authority issued the new interpretative Guidelines of Legislative Decree no. 24/2023, implementing the EU Whistleblowing Directive. The new Guidelines aim at providing practical guidance to those employers that, pursuant to the new law, are now required to implement their own internal reporting channels.

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