Baker McKenzie’s Sanctions Blog published the alert titled Ukraine imposes new sanctions against Russian financial sector on 21 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 Ukraine introduces sanctions targeting Russian nuclear industry on 16 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 Ukraine introduces sanctions targeting Russian nuclear industry on 7 February 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
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.
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.
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.
Following concerns expressed about the capacity of Notified Bodies to certify medical devices in accordance with the EU Medical Device Regulation within the transitional periods provided therein, on 6 January 2023 the European Commission adopted a proposal to extend the transitional periods under Article 120(3) of the MDR.