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Welcome to the July/August 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:

European Union

  • The European Medicines Agency’s first Brexit Q&A guide for European pharma companies faces criticism from the UK’s ABPI
  • New EudraVigilance system
  • Brexit Employment Survey
  • Brexit Updates: The Queen's Speech and what it does not say about the pharma sector and the MHRA
  • Brexit Updates: Process for relocating the European Medicines Agency and European Banking Authority agreed by EU 27 at Brussels summit
  • ECJ rules on vaccine product liability case

UK

  • NHS guidelines on managing conflicts of interest come into force
  • ABPI applies for judicial review of NHS drugs pricing policy

Africa

  • Africa's Healthcare Market: Prospects and Projects

Belgium

  • Commission opens formal investigation into alleged excessive pricing of cancer medicines by Aspen – the start of a new enforcement trend?
  • Belgian Sunshine Act entered into force – legal basis for transparency obligations for transfers of value

France

  • Introduction of a bill of law to the French Senate so as to ratify the ordinance of January 19, 2017 modifying the Anti-Gift Law regime

Hungary

  • New rules on professional consultation with the National Institute of Pharmacy and Nutrition (OGYÉI)
  • New practice of the OGYÉI regarding MAH transfers

Italy

  • Adoption of the new Medical Device and In Vitro Diagnostics Regulations
  • Amendments to the Code of Public Contracts
  • The Italian Constitutional Court confirms the legitimacy of the rules for the balancing of the overrun of the expenditure ceiling for the purchase of innovative drugs
  • The Italian Data Protection Authority issues the first Guide on the application of the EU General Data Protection Regulation

Spain

  • New requirements to improve the quality and safety standards of human tissues and cells for use in humans
  • Study on off-label use of medicinal products in the European Union
  • Purely plant-based products cannot be marketed or advertised with designations such as "milk", "cream", "butter", "cheese" or "yoghurt"

Turkey

  • Turkey Adopts New Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use
  • TİTCK Results Reveals Decreased Unsafe and Non-Compliant Medical Devices and Cosmetic Products
  • TİTCK Announces New Electronic System for Value Transfers
  • Turkey Announces Pharmaceutically Similar Products for Pricing of Medicinal Products for Human Use

Ukraine

  • Baker McKenzie named Law Firm of the Year in Medicine and Pharmaceutical Law by Ukrainian legal awards
  • Sanctions and Compliance
  • Currency Control Restrictions
  • Public Procurement
  • Healthcare Organizations
  • Intellectual Property
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