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Welcome to the May 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: China

  • CFDA draft policy on drug innovation

European Union

  • European Medicines agency publishes whistleblower policy

Africa

  • Africa’s Healthcare Market: Prospects and Projects Event

Belgium

  • Merger control: Dow/DuPont - European Commission deems 5:4 reduction of competing R&D pools ‘unacceptable’

France

  • Research tax credit: seconded researchers’ expenses may be included in operating costs
  • Research tax credit: a patent application may justify eligibility for research tax credit for a prior period
  • The modified French Sunshine Act disclosure regime is applicable

Italy

  • New rules on private-to-private bribery
  • Assobiomedica published the comments by MedTech Europe on the new Code of Ethics
  • The Administrative Court of the Lazio Region (TAR) confirms the prohibition for the pharmacist to carry out wholesale distribution of medicines
  • The National Anti-corruption Authority (ANAC) approved the new Regulation on the vigilance on public contracts

Spain

  • New tax on sweetened drinks

Turkey

  • Turkish Pharmaceutical Market: What the Numbers Say
  • TİTCK Announces New Procedures for License Applications
  • TİTCK Announces Changes for Certification Process for Cosmetic Products
  • Turkey Ratifies the MEDICRIME Convention
  • Turkey revises rules on compulsory licensing
  • Turkey Cracks Down on Unsafe and Non-Compliant Medical Devices and Cosmetics Products
  • Turkey Adopts New Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use

Ukraine

  • Recast of the regulatory framework for reimbursement, pricing and public procurement of pharmaceuticals in Ukraine
  • The register of persons responsible for entering medical devices into circulation
  • New lists of OTC pharmaceuticals and pharmaceuticals prohibited from advertising
  • The moratorium on state inspections does not extend to surveillance activities on medical devices
  • Cancellation of MOH orders on the registration of medical devices
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