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Welcome to the November/December 2017 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:

Guest Feature

  • Healthcare goes digital but regulation hard to disrupt

Europe

  • MedTech Europe pushes for conformity post-Brexit
  • Healthcare goes digital but regulation hard to disrupt
  • Digitisation of healthcare
  • Digital disruption in healthcare and the role of regulators
  • What does this mean for health tech companies?

Hungary

  • The National Institute of Pharmacy and Nutrition (OGYÉI) published Guidelines on cosmetic product claims.
  • The Competition Office imposed a fine on Sandoz due to unlawful promotion of medicinal products

Italy

  • The Council of State declares the unlawfulness of regional acts limiting the prescription of innovative oncologic drugs
  • The consultation period on the draft of the first Implementing Regulation of the European Regulations on medical devices and in vitro diagnostic medical devices expired
  • Transparency International Italia publishes a report on corruption in Italy for 2017
  • The Council of State provides clarifications on the prohibition to provide human blood for profit
  • The AIFA establishes the new criteria for the classification of innovative drugs and innovative oncological drugs

The Netherlands

  • A shift in discussion on pricing and reimbursement of medicines in the Netherlands

Russia

  • On what basis can organizations carrying out clinical studies of a biomedical cellular product export obtained biological material?
  • Distance retail trade in medicines: pharmacies will be given a right to distance retail trade in over-the-counter medicines
  • New national standard in the field of telemedicine

South Africa

  • New SA medicines regulator expected to address past ailments

Turkey

  • Turkey Makes Over Cosmetics Sector Guidelines
  • Turkey Revises Pricing Rules on Medicinal Products for Human Use
  • Turkey Updates Guidelines on Package Information, Manuals and Tracking of Medicinal Products for Human Use
  • Turkey Cracks Down on Counterfeit and Illegal Products
  • Turkey Becomes PIC/S Member
  • Turkey Publishes Draft Regulation on Variations in Medicinal Products for Human Use
  • Turkey Updates Cosmetics Regulation

UK

  • Don't Go Faking My Heart - English High Court Highlights Healthtech IP Risks

UAE

  • Mecomed members agree to stop sponsoring individual healthcare professionals to attend third party conferences as of January 1, 2018

Ukraine

  • The new procedure for revising the National Essential Medicines List may hamper public procurement of pharmaceuticals
  • Launch of the healthcare system reform increases importance of NEML-listing
  • Typical requirements to vertical concerted actions on supply and use of goods
  • New draft law introducing licensing of medical devices
  • Methodical recommendations on the preparation and implementation of anti-corruption programs
  • Ukraine’s tax treaties with the UK and Turkey to be amended
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