Ukraine

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Recent Articles

  •  
    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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  •  
    13/08/2024
    Europe

    Antibody Appeals Uncovered

    Since the first approval of Muromonab-CD3 in 1986, antibodies have become progressively more common, frequently reaching a ‘blockbuster’ status. According to statistics provided by Statista in March, 5 out of 10 top-selling drugs were antibodies in 2023. Therefore, patents related to antibodies are now of considerable interest and significance to the pharmaceutical industry. They provide protection for commercially important inventions, spur further investment, and allow patients to benefit from these therapeutics. Our report provides a high-level analysis of the Board of Appeal decisions...
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  •  
    05/08/2024
    Europe

    TMO4+ and “First Ready, First Connected” – musings from the workgroup reports

    OverviewThe following is an update to our initial Law Now titled “TMO4+ and “First Ready, First Connected” – reforming a disorderly queue?” dated 29 May 2024 which primarily reported on CUSC Modification Proposals (“CMP”) 434 and 435 as they were originally set out in National Grid Electricity System Operator’s (“NGESO”) original proposal form.Since then, the connection reform process has continued at pace through a series of workgroup consultations, culminating in workgroup reports for the CMP 434 and 435 proposals being published on...
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