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  1. Legal news
    18 March 2019
    French Legal Framework for the exchange of health data by secured health messaging systems
    www.twobirds.com/en/news/articles/2019/france/french-legal-framework-for-the-exchange-of-health-data-by-secured-health-messaging-systems

    Before the entry into force of the GDPR on May 25th 2018, healthcare professionals and facilities and professionals in medico-social sectors empowered by law in France had to comply with the provisions stated in the ...

  2. Legal news
    24 January 2020
    Access to documents contained in a MA application file
    www.twobirds.com/en/news/articles/2020/france/acces-aux-documents-contenus-dans-le-dossier-d-une-demande-amm

    European Medicines Agency (EMA) had communicated to third parties (with some omissions), information contained in toxicological test reports and clinical trial reports obtained in a MA application file on the grounds ...

  3. Legal news
    02 December 2019
    The French Health Data Hub becomes reality
    www.twobirds.com/en/news/articles/2019/france/the-french-health-data-hub-becomes-reality

    The French Health Data Hub was born officially with the publication on 30 November 2019 of a ministerial decision (arrêté).

  4. Legal news
    02 July 2019
    Transfer of value: amendments to the French “anti-gift” provisions by the draft Health Act
    www.twobirds.com/en/news/articles/2019/global/transfer-of-value-amendments-to-the-french-anti-gift-provisions-by-the-draft-health-act

    The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”)

  5. Legal news
    21 April 2020
    COVID-19: ANSM guidance on Data Protection requirements for on-going trials
    www.twobirds.com/en/news/articles/2020/france/covid-19-ansm-guidance-on-data-protection-requirements-for-on-going-trials-in-france

    French data protection law on health research applies to all sponsors, whatever their country of establishment, when they perform clinical trials in France.

  6. Legal news
    29 October 2018
    France: Measures in favor of generic and hybrid drugs under discussion in the French Parliament
    www.twobirds.com/en/news/articles/2018/france/measures-in-favor-of-generic-and-hybrid-drugs-under-discussion-in-the-french-parliament

    The draft bill for the financing of the social security scheme for 2019, under discussion in the Parliament, contains, in its Article 43, amendment proposals to the French Public Health and Social Security Codes in ...

  7. Legal news
    04 July 2018
    Flash Pharma - Anti-gift provisions - July 2018
    www.twobirds.com/en/news/articles/2018/france/flash-pharma-anti-gift-provisions-july-2018

    Transfer of value: new French legal framework effective as of July 1st but implementing texts are still missing.