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Welcome to the January/February 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:

Guest Feature

  • FDA And 3D Printing — What Will The Regulatory Regime Become?
  • U.S. Supreme Court redefines doctrine of patent exhaustion

Europe

  • RoHS Directive: Removal of "hard stop" deadline for electrical devices
  • Brexit Round Up
  • The Road map for implementation of EU Regulations on Medical Devices and In-vitro Diagnostics Medical Devices has been published

Belgium

  • Belgian Digital Health Valley – Paving the way for health apps to play a bigger role in Belgian healthcare

Germany

  • CJEU decision on VAT treatment of discounts granted to private health insurances

Italy

  • Whistleblowing Act in the private sector approved
  • Council of State requests the opinion of the ECJ on the applicability of the public tenders legislation on agreements between public healthcare structures and classified private hospitals
  • ECJ provides clarifications on qualification of software as medical devices
  • Council of State rules on possibility to obtain compensation for failure to include a drug in Class A
  • Report on the public expenditure for the purchase of medical devices in 2016 has been published
  • Payback: approval of amendment to the Budget Law 2018 clarifying the terms of VAT deductibility

Poland

  • New Minister of Health
  • Draft Transparency Act
  • Severe penalty for misleading advertisement of dietary supplements
  • Postponed obligation to submit data to the Integrated System for the Monitoring of Trade in Medicinal Products

Spain

  • Medical training and Personal Income Tax

Turkey

  • Safety First: TÄ°TCK Announces Certified Pharmacovigilance Service Providers
  • It is now easier to keep track of your goods in customs
  • Data Protection Authority Publishes Guidelines on Personal Data Security
  • Data Protection Authority publishes the regulation on data controllers registry

Ukraine

  • Healthcare system reform
  • State healthcare financing only for NEML-listed pharmaceuticals and other changes introduced due to healthcare reform approval
  • Typical Requirements for Vertical Concerted Actions of Business Entities
  • More pharmaceuticals are eligible for public procurement due to extension of the National Essential Medicines List
  • VAT rate of 7% now equally applies to all medical devices
  • Law on moratorium on inspections in 2018
  • New list of OTC pharmaceuticals and pharmaceuticals prohibited from advertising
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