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Welcome to the December 2018 edition of our newsletter. The EMEA Healthcare Industry Group Newsletter is your regular digest of legal developments affecting the life science and healthcare industries across the region.


In this Issue :

Germany

  • Keeping generics off the market under German Law

Italy

  • The Italian Medicines Agency states that the deposit of promotional materials for
    medicinal products is only possible in digital form
  • Payback on medicinal products: possible solution within the 2019 Budget Law
  • Farmindustria publishes its Position Paper on biosimilars
  • Transparency between pharmaceutical companies and healthcare operators and
    organizations: the provisions of the Sunshine Act
  • Parapharmacies are allowed to sell medical devices and products for diabetics

Russia

  • The Government of the Russian Federation has approved a new procedure for
    registering prices for medicines from the vital and essential medicines list
  • The Ministry of Healthcare has put forward an initiative to improve the protection ofpatent rights to medicines
  • The Ministry of Industry and Trade is planning to exclude medicines from the list of
    goods subject to conformity assessment

Spain

  • The new Price Reference Order of 2018 has been published and it still maintains the
    groups that were invalidated by the Supreme Court
  • Orphan medicinal products: Measures to promote research and development and the
    current situation in the European Union

Switzerland

  • Swiss leading decision on qualification of fertility app as medical device

UK

  • Legalisation of medicinal cannabis in the UK
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