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Following a new regulation of the Securities and Exchange Commission of Thailand defining new characteristics of bills (i.e., bills of exchange and promissory notes) that are considered securities, the Capital Market Supervisory Board of Thailand has amended the requirements for offerings of bills to match the new definition. The new offering requirements will come into effect on 16 March 2024.

In a move to develop Thailand’s position as a regional hub of investment, the Office of the Securities and Exchange Commission began a public hearing on the new securities and derivatives business licensing regime on 9 February 2024, designed to increase flexibility and decrease costs for business operators.

We’re pleased to present the 14th edition of Ukrainian Laws in Wartime: Guide for International and Domestic Businesses, a brief overview of the key features of wartime legislation. In this edition you’ll explore pertinent responses to the most common questions currently examined and addressed by international and Ukrainian businesses.

The transition from the Banking Executive Accountability Regime to the Financial Accountability Regime is due to take place on 15 March 2024 for the banking industry. Companies covered by the regime need to be aware of these changes and ensure relevant documentation, including relating to accountable persons and variable remuneration, is up to date.

On 13 February 2024, the FCA issued a Final Notice to Floris Jakobus Huisamen, the former director and compliance officer of London Capital & Finance plc (LCF), fining him GBP 31,800 and banning him from working in financial services in relation to misconduct connected to financial promotions issued by LCF. This Final Notice follows the FCA’s previous censure of LCF in October 2023 for connected behaviour. In this alert we draw out the key takeaways that compliance officers should bear in mind from the FCA’s enforcement action.

On 31 January 2024, the Italian Medicines Agency (AIFA) published the Guidelines on applications for marketing authorizations submitted through the national procedure. The purpose of the Guidelines is to provide detailed information about (i) the correct submission of applications for marketing authorization and the relevant administrative and technical documentation, (ii) the steps and timeframes for the AIFA’s assessment of such applications, including any requests for clarification and/or further documentation, and (iii) the publication of the results of the preliminary assessment, the procedures for issuing the final resolutions as well as for their notification and publication in the Official Gazette.

On 23 January 2024, the European Medicines Agency published an updated version of the user guide for micro, small and medium-sized enterprises in the pharmaceutical sector. The revised guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorization of medicines for human and veterinary use.

With Decree of 29 December 2023, published on 9 February 2024, the Ministry of Health identified the criteria and procedures for the payment of the annual fees for the monitoring and management of the Fund for the Governance of Medical Devices referred to in Article 28 of Legislative Decree No. 137/2022.