On 3 May 2023, the European Medicines Agency launched a public consultation in order to review the rules on the publication of clinical trial information submitted through the Clinical Trials Information System (CTIS). The CTIS is the dedicated web portal for the submission of authorizations relating to clinical trials and their management in Europe, aimed at streamlining clinical trial applications and the supervision of clinical trials.
On 3 May 2023, the European Commission presented to the European Parliament and the Council a proposal for a Directive on fighting corruption. The proposal, which refers to corruption in both the public and private sector, provides for the extension of the list of criminal offenses in each EU Member State to include misappropriation, trading in unlawful influence, abuse of functions, as well as obstruction of justice and unlawful enrichment. In addition, the proposal provides for the increase in the level of applicable sanctions and the harmonization of aggravating and mitigating circumstance.
With decision No. 7759 published on 8 May 2023, the Administrative Court of the Lazio Region ruled on the determination whereby the Italian Medicine Agency rejected the request for an exemption from the withdrawal of a marketing authorization filed by the relevant holder due to the discontinuation of the supply of the active ingredient by its manufacturer.
Several new employment measures have become law, dealing with redundancy protection for mothers and those returning from family leave, as well as creating new rights to carer’s and neonatal leave. There is also a new right to the allocation of tips. However, the rights might not come into force for a year or two, and some of the detail of the rights remains to be confirmed.
We’re pleased to present the eleventh edition of Ukrainian Laws in Wartime: Guide for International and Domestic Businesses, a brief overview of the key features of wartime legislation.
Marketing authorization holders have three years from 17 May 2023 to remove any “negative formulations” from their existing and future medicines packaging.
Baker McKenzie’s Sanctions Blog published the alert titled Canada Enacts Sanctions Against Moldova on 2 June 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
At the end of March, the Antimonopoly Committee of Ukraine published its Annual Report for 2022.The AMC focused on markets that are strategically important for the country, including the markets for: (i) electricity, (ii) natural gas, (iii) light oil products, (iv) housing and communal services, (v) construction materials (i.e., cement), (vi) medicines, (vii) real estate, (viii) information technologies, (ix) retail, and (x) other industry sectors.
The European Union actively uses anti-dumping and anti-subsidy (or countervailing duty) investigations to protect the EU manufacturing industry from competition from imports. Imports from Türkiye are a prime target for these investigations: in the past 20 years, imports from Türkiye were targeted in 15 anti-dumping and anti-subsidy investigations. Five of these investigations were initiated in the last three years.
Baker McKenzie’s Sanctions Blog published the alert titled Sanctions Enforcement Around the World, the Swedish Perspective on 31 May 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.