Sciences de la vie - soins de santé

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eAlerts Récentes

  •  
    18/06/2024
    Pologne

    When medical garment is a medical device – communication from the Polish authority

    GB PL
    In May 2024, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (President of the URPL) issued a Communication on the principles for determining the regulatory status of medical garments (Communication). In the Communication, the President of the URPL outlined the evaluation criteria it follows when issuing an opinion on whether used garments in healthcare facilities meet the definition of a medical device.The President of the URPL explained that, depending on its intended use, it will have a different regulatory status, and will be subject...
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  •  
    13/06/2024
    Europe

    What’s in a name? The use of a product code in a clinical trial protocol fails to circumvent clinical trial prior art

    The use of product or sponsor codes in clinical trial related documents is common practice in the pharmaceutical space. However, such codes may not always be sufficient to disregard a publication as relevant prior art against patent claims.In recent decision T 1255/21, the EPO Board of Appeal finds that the use of a product code or sponsor code for a compound or composition in a clinical trial protocol does not affect the status of the protocol as prior art if the skilled person would have been able to identify the compound or composition based on the description of the components of the product...
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  •  
    04/06/2024
    Pologne

    Poland’s Advertising Council amends Code of ethics to include advertising for food supplements

    GB PL
    In May 2024, the Union of Associations Advertising Council (Advertising Council), an NGO involved in corporate responsibility in advertising, developed a comprehensive self-regulation on ethical advertising of food supplements, which is now part of the Code of Ethics for Advertising, a set of rules defining what is acceptable and what is unethical in advertising. The Code of Ethics for Advertising is to be followed by entrepreneurs, especially advertisers and other entities engaged in advertising activities in Poland.Entities who advertise food supplements have so far relied on two sets of rules...
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  •  
    16/05/2024
    Europe

    A broader interpretation of "substance or composition" - good news for patentees at the EPO?

    A recent decision from the EPO Boards of Appeal (T 1252/20) potentially paves the way for more diverse products to be patentable in Europe using the medical use claim format.The background:Article 53(c) of the European Patent Convention (EPC) excludes methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body from patentability. However, this does not apply to products, in particular substances or compositions, for use in any of these methods.Furthermore, Articles 54(4) and (5) EPC provide that a claim to a known substance...
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  •  
    14/05/2024
    Hongrie

    EU introduces criminal offences and penalties for sanctions violations

    Criminal offencesUnder the Directive, the following conduct constitutes a criminal offence when committed intentionally and in violation of restrictive measures or a national provision implementing restrictive measures:making funds or economic resources available directly or indirectly to, or for the benefit of, a designated person, entity or body;failing to freeze funds or economic resources belonging to or owned, held or controlled by a designated person, entity or body;enabling designated natural persons to enter into, or transit through, the territory of a EU member state;entering into or continuing...
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  •  
    16/04/2024
    APAC region

    Top developments and predictions in the Life Sciences & Healthcare sector in Asia-Pacific

    In this round-up, we look back at the top developments over the last 12 months in the life sciences & healthcare (LSHC) sector, and we look to the future with our top predictions for the coming year for businesses operating in the Asia-Pacific region.In 2023, China enhanced rules for the management of human genetic resources. It also intensified regulatory oversight in the sales of pharmaceuticals, medical devices, and cosmetics, particularly in the realm of online sales. Meanwhile, the Hong Kong government is actively working on unlocking the city’s potential in the Life Sciences &...
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