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UNDERSTANDING THE …

    https://www.hoganlovells.com/~/media/hogan-lovells/pdf/publication/jmdrfeb2010_pdf.pdf

    Promotion of off-label use of medicines by European …

      https://www.efpia.eu/media/25016/promotion-of-off-label-use-of-medicines-by-european-healthcare-bodies-in-indications-where-authorised-medicines-are-available-november-2011.pdf
      Promotion of off-label use of medicines by European healthcare bodies in indications where authorised medicines are available EFPIA represents the pharmaceutical industry …

    Understanding the Promotion of Medical Devices in the …

      https://www.hoganlovells.com/en/publications/understanding-the-promotion-of-medical-devices-in-the-european-union
      Understanding the Promotion of Medical Devices in the European Union. Understanding the rules governing the promotion of medical devices in the European Union (EU) can …

    The EU MDR: Medical Device Advertising & Promotion

      https://www.podymos.com/post/how-does-the-mdr-affect-medical-device-advertising-promotion/
      The EU MDR represents the unified European regulatory requirements for Medical Devices that must be followed throughout Europe to secure and maintain your CE mark. Unlike the previous Medical …

    Off-Label Use of Medicines: A Comparative Study on the …

      https://www.cambridge.org/core/journals/european-journal-of-risk-regulation/article/offlabel-use-of-medicines-a-comparative-study-on-the-regulation-of-medicinal-products-in-selected-european-union-member-states/E68E2BD899B41A20FB9814B726D06DDA
      Off-label practices are a reality; thus, it is advisable to elaborate policy measures in order to address these practices and condition them on some requirements, …

    Pharmaceutical & medical device advertising regulation …

      https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/germany
      Art. 7 MDR (e.g. no misleading claims regarding to the device’s intended purpose, safety and performance by (a) ascribing functions and properties to the device …

    Regulating Off-label Use of Medicines in Europe

      https://haiweb.org/media-resource/regulating-off-label-use-of-medicines-in-europe/
      Off-label uses have not undergone the type of benefit-risk harm assessment required in the procedure for medicines’ marketing authorisation. Yet, doctors might …

    Off-Label Promotion of Medical Devices: Seeking Clues …

      https://www.mastercontrol.com/gxp-lifeline/off_label_promotion_enforcement_0409/
      Off-Label Promotion of Medical Devices: Seeking Clues from the Past to Protect Against Increased Enforcement in the Future April 17, 2017 Amy Colvin and …

    Advertising and medical devices according to the …

      https://deltamed.pro/en/news/advertising-medical-devices-european-regulation
      Advertising and medical devices according to the European Regulation Mar 19 , 2020 Advertising and medical devices according to the European Regulation Among the innovations introduced by the new Medical …

    3. Off-label use: Legal framework in Europe - EUPATI

      https://learning.eupati.eu/mod/book/view.php?id=913&chapterid=896
      This means that off-label use is not covered by EU pharmaceutical legislation. Off-label use is however recognised as a concept by EU law (recital 2 of the Paediatric Regulation …



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