On 19 January 2023, the Court of Justice of the European Union specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).

Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces three new sets of sanctions against persons contributing to the Russian aggression against Ukraine on 28 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 imposes sectoral sanctions against all banks and financial services providers operating in Russia on 23 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 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.