The Antitrust Law Update will take place on 26 September 2023 from 10:00am to 4:00pm CET. Please note this event will be held in German only.
This publication features the latest Employment developments in Italy.
The Antitrust Law Update will take place on 26 September 2023 from 10:00am to 4:00pm CET. Please note this event will be held in German only.
Baker McKenzie’s Sanctions Blog published the alert titled Blog Series: Sanctions Enforcement Around the World, the Czech Perspective on 31 July 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
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.
The 8th Frankfurt Tax Congress will take place on 17 October 2023 from 9:25am to 6:00pm CET. Please note this event will be held in German only.
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.
On 27 June 2023, the Italian Medicines Agency (AIFA) announced the release of new features for the e-Dossier Price and Reimbursement web portal. The portal, available at the AIFA Services Portal, enables the preparation of dossiers in digital format to support reimbursement and price claims.
On 22 June 2023, the Court of Justice of the European Union ruled in the Joined Cases C-6/21 P and C-16/21 P on the impartiality requirement of the scientific committees’ members and experts involved in the European Medicines Agency’s activities.
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).