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  •  
    07/11/2024
    Europe

    A clinical trial protocol as a pointer to the claimed crystalline form of a compound (T 1152/21)

    In recent decision T 1152/21, the Board of Appeal finds that a phase I and phase II clinical trial protocol provided a pointer to the claimed crystalline form of a compound, despite the lack of any trial results.BackgroundClaim 1 of the main request was directed to a crystalline polymorph Form A of the free base of palbociclib with particular characteristics, including a particular BET Nitrogen measured specific surface area and volume mean diameter characterized by a D[4,3] value.“According to the patent (paragraph [0004]), using palbociclib as a potent and selective CDK4/CDK6 inhibitor...
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  •  
    23/10/2024
    China

    Supreme People’s Court Issued Interpretation on Punitive Damages for Food and Drug Disputes

    The Supreme People's Court (“SPC”) of the People's Republic of China (“PRC”) has recently promulgated the Interpretation on Several Issues Concerning the Application of Law to the Trial of Cases of Disputes over Punitive Damages in Food and Drugs (“Interpretation”), taking effect from August 22, 2024. The Interpretation has 19 articles in total covering various aspects regarding punitive damages related to food and drug as prescribed in related laws. This newsletter will focus on punitive damages in the food sector only.The history of punitive damages in the...
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  •  
    14/10/2024
    China

    Temporary Import of Clinically Urgent Use Medical Devices

    On 19 July 2024, the National Medical Products Administration and the National Health Commission jointly issued the Announcement on the Temporary Import and Use of Clinically Urgent Medical Devices for Medical Institutions, with immediate effect. On 14 September 2024, Beijing Drug Administrative Authority, together with three other local departments, issued the Beijing Municipal Implementation Plan for Facilitating the Temporary Import of Clinically Urgent Use Medical Devices (Trial).  Please see our newsletter here with a brief introduction on the temporary import of clinically urgent medical...
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  •  
    08/10/2024
    Belgium

    The new payment rules in public procurement are also of relevance in the healthcare sector

    GB NL FR
    The new payment rules (Royal Decree of 12 August 2024) put an end to the classic distinction between the verification period and the subsequent payment period. Starting from 1 January 2025, a single processing period will be the starting point. For hospitals (and other contracting authorities active in the healthcare sector), a processing period of 60 days will be applied, which can be extended, where necessary, by a verification period of 30 days, particularly for contracts related to their specific activity in the healthcare sector. In this newsletter, the rules specific to healthcare sector...
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  •  
    02/10/2024
    Belgium

    First annual report on Belgian foreign direct investment screening

    On 1 June 2022, following the adoption of Regulation (EU) 2019/452 of 19 March 2019 establishing a framework for screening foreign direct investments in the EU, the various Belgian competent governments concluded a draft cooperation agreement, ratified by all competent Belgian parliaments, which aimed to introduce a foreign direct investment (“FDI”) screening mechanism in Belgium.The FDI control mechanism, which entered into force on 1 July 2023, provides for a mechanism of mandatory ex ante notification to the Interfederal Screening Committee (“ISC”) for investment projects...
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  •  
    02/10/2024
    Ungarn

    Hungary begins implementation of EU AI Act with passage of Resolution

    The Hungarian government has issued Resolution 1301/2024. (IX. 30.), which establishes the foundation for creating the body responsible for implementing the tasks required by the EU AI Act. In issuing this resolution, Hungary has begun preparations for enforcing the regulation, which means that companies should now prepare for compliance by reviewing the AI systems they use, assessing these systems' alignment with the EU AI Act's requirements, and preparing the necessary risk management documentation to ensure transparency, accountability, and safety.Hungary’s new enforcement body will:Operate...
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