Starting from 31 January 2023, the Clinical Trial Information System (CTIS), provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area (EEA) countries.
On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency (EMA), 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.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces a new set of sanctions against Russian and Belarusian companies on 2 February 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
A failure to provide accurate and complete information to HMRC in relation to a quantity of goods on which Inward Processing Relief has been claimed, gives rise to a customs debt on all the goods covered by the relevant bill of discharge report. This was decided by the UK First Tier Tribunal in the case Thyssenkrupp Materials (UK) Ltd v HMRC on 30 November 2022.
The amendments to the Law on the Regulation of Electronic Commerce that was adopted on 1 July 2022 will enter into force on 1 January 2023. As part of these amendments, the Regulation on Electronic Commerce Intermediary Service Providers and Electronic Commerce Service Providers was published on the Official Gazette no. 32058 dated 29 December 2022.
The Regulation aims to detail and clarify the requirements under the Law.
In the last month, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) published five new decisions on its website relative to the promotional practices of companies under investigation. The NIPN imposed fines for infringements within the range of HUF 3 million (approx. EUR 7,700) to HUF 31 million (approx. EUR 79,500).
Baker McKenzie’s Sanctions Blog published the alert titled Switzerland implements the 9th package of EU sanctions against Russia on 1 February 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Japan introduces further sanctions against Russia on 30 January 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
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.
Starting from 31 January 2023, the Clinical Trial Information System, provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area countries. The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical trial application according to the Clinical Trials Directive or through the single portal. As of 31 January 2023, submission of clinical trial applications through the single portal will become mandatory.