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  1. Legal news
    17 November 2015
    Singapore Parliament Passes the Human Biomedical Research Bill Regulating Human Biomedical Research and Tissue Banking Activities
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/singapore-parliament-passes-the-human-biomedical-research-bill

    On 18 August 2015 the Singapore Parliament passed the Human Biomedical Research Bill. The introduction of the Bill will provide overdue clarity on the legal frameworks for (a) the conduct of human biomedical research, ...

  2. Legal news
    17 November 2015
    Notification of articles under REACH Regulation: the whole is just as burdensome as the sum of its parts
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/notification-of-articles-under-reach-regulation

    In its judgment of 10 September 2015 , the Court of Justice of the EU (CJEU) has rendered a decision on a request for a preliminary ruling relating to the obligations under the REACH Regulation for articles containing ...

  3. Legal news
    17 November 2015
    Second marketing authorisation being the first: Polish case law report on supplementary patent protection for medicinal products
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/second-marketing-authorisation-being-the-first

    On 9 July 2015, the Voivodeship Administrative Court in Warsaw (VAC) (ref. No. VI SA/Wa 285/15) ruled that a marketing authorisation (MA) granted for a combination product, the original API of which had already received ...

  4. Legal news
    17 November 2015
    Scope of “Global Marketing Authorisation” concept addressed in judgment by the General Court
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/scope-of-global-marketing-authorisation-concept-addressed-in-judgment-by-the-general-court

    On 15 September 2015, the General Court delivered its judgment in Case T-472/12, Novartis Europharm v European Commission (supported by Teva). Novartis was challenging a marketing authorisation (MA) granted to Teva ...

  5. Legal news
    17 November 2015
    New Spanish Patent Act: changes for Life Sciences Litigation
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/new-spanish-patent-act-changes-for-life-sciences-litigation

    The Spanish Parliament approved a new Patent Act on the 24 July 2015. This Act will enter into force on 1 April 2017. With over one and a half to go it is likely that some changes to the Act will be implemented in the ...

  6. Legal news
    17 November 2015
    France: Recent developments on clinical trials agreement
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/france-recent-developments-on-clinical-trials-agreement

    In 2013, clinical research was declared a priority for the French economy by the Government. To this end, it entered into an agreement with the healthcare industry, in which the latter committed to accelerate and ...