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  10/09/2024

  Ukraine

  Ukraine adopts regulation on collection and use of human cells and biospecimens for R&D

  On 30 August 2024, Ukraine introduced its first comprehensive regulation governing the collection, storage, and use of human biospecimens for research and development purposes. The regulation, approved under Cabinet of Ministers’ Resolution No. 999, outlines the legal and ethical framework for biobanking activities involving biomedical research, while safeguarding donor rights and data privacy. The regulation is a significant development in supporting Ukraine’s advancement in health sciences and biotechnology.Key Provisions The key provisions of the regulation include the following:Scope:The...

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  10/09/2024

  International

  CMS Annual Review of English Construction Law Developments: An International Perspective

  We are pleased to announce the publication of the 2024 edition of our internationally focused Annual Review of English Construction Law Developments. The Annual Review summarises key developments in English construction law over the previous calendar year including developments in related common law jurisdictions. The publication has been prepared with our international clients in mind and aims to provide a greater degree of background and analysis than our regular Law-Now alert service.This year’s edition has a strong focus on exclusion and limitation clauses, with more than half of the...

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  02/09/2024

  Ukraine

  Ukraine tightens rules on labelling medicines

  On 21 August 2024, the Parliament of Ukraine adopted amendments to the Law on Medicinal Products as a part of an effort to align Ukrainian legislation with EU regulations, particularly Article 54 of Directive 2001/83/EC. These Amendments, however, introduce stricter rules than the EU legislation.Key provisions of the Amendments:1.    Prohibition on non-compliant labelling:The Amendments strictly prohibit the inclusion of any advertising information or references to entities other than the Marketing Authorisation Holder (MAH) or the manufacturer on the packaging of medicinal...

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  29/08/2024

  Ukraine

  Ukraine to Allow Limited Parallel Import of Medicines from 2025

  On 27 July 2024 a Law of Ukraine On Amendments to Certain Laws of Ukraine Concerning Parallel Import of Medicinal Products (the “Law”) came into force. The Law legalises limited parallel import regime for medicinal products as of 1 January 2025.The Law will bring the following key changes: From 1 January 2025, the parallel import of medicines into Ukraine will be lawful. At first, it will be possible to import medicines into Ukraine from EU countries, Iceland, Liechtenstein, and Norway only.It will be allowed to import medicines identical or similar to those registered in...

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  28/08/2024

  Ukraine

  Ukraine launches large-scale privatisation

  The State Property Fund of Ukraine (SPFU) has unveiled the Large Privatisation-2024 project, an ambitious initiative to attract strategic investors and stimulate economic growth through the privatisation of state-owned assets.Following the success of small-scale privatisation efforts, this initiative is a key element of Ukraine’s broader economic reform strategy. It aims to enhance transparency, improve efficiency, and drive foreign investment into the country. The key highlights of the privatisation effort are as follows:Top assets for privatisation. The programme has identified several...

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  16/08/2024

  Europe

  CMS Data Protection Update EU and Germany, August 2024

  I.    The latest from the data protection authorities and current topics1.    AI Act: Legislative proceedings finalisedThe legislative proceedings for the AI Act have been completed and came into effect on 1 August 2024. The CMS homepage provides an overview: Looking ahead to the EU AI Act (cms.law). The data protection authorities have published the following notifications and are gearing up for their new duties: Statement 3/2024 of the European Data Protection Board (EDPB) on data protection authorities' role in the Artificial Intelligence (AI) Act...

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