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Welcome to the February 2019 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:

Belgium

  • New Belgian law liberalizing distribution channels for medical devices opens opportunities to review supply chain and expand market access

Europe

  • Implementing safety features under the Falsified Medicines Directive
  • EMA announces closure of London office from 1 March 2019
  • European Commission Report on Competition Enforcement in the Pharma Sector
  • Supplementary protection certificates cannot be granted to medicinal products incorporated by medical devices
  • EMA's new guidelines on the quality of water for pharmaceutical use
  • EMA issues new PV paediatric guidelines
  • Concerns grow over medical devices supply shortfalls in no-deal Brexit
  • Call for harmonised sunshine and transparency laws across Europe

France

  • New French “IP box”

Hungary

  •  The GVH imposes a fine on a pharmaceutical company

Italy

  • Medical devices - guidelines for the drafting of tender specifications
  • Bribery in the pharmaceutical sector does not cover nutritional supplements
  • Increase in clinical trials in Italy
  • Medical devices: The CE marking is sufficient to certify the conformity of the products to the tender requirements
  • A medicinal product repackaged for its "off-label" use can be reimbursed by the National Health System

Russia

  •  Recent amendments to the procedure for the entry of medicines into civil circulation

South Africa

  • Competition Commission of South Africa's inquiry into the private healthcare sector nears its end

Spain

  • Impact of Organic Law 3/2018 on personal data protection in the field of data processing in health
    research

Switzerland

  • Project to bring Swiss law in line with MDR and IVDR to ensure continued mutual recognition of
    medical devices in the EEA

Turkey

  • TİTCK publishes batch release guideline
  • Turkey to introduce a marketing authorization requirement for medicines procured from abroad
  • Cosmetics safety: Turkey continues cracking down on unsafe and noncompliant cosmetic products
  • TİTCK announces changes for sanctions regarding meeting notification duty

Ukraine

  • Strategy on implementing the state pharmaceuticals policy may limit IP rights of R&D companies
  • The MOH and the MEDT do not recommend that public procurement entities use large multi-item lots
    and manufacturers' authorization letters
  • SI labeling requirement postponed until 2021
  • The CMU approved risk criteria to control compliance with pricing regulations
  • NBU cancels registration and maximum interest rate cap for cross-border loans
  • Kazakhstan amends its pharmaceutical legislation

United Kingdom

  • MHRA ramps up detail on no-deal plans
  • MHRA requires information from MA Holders regarding "Grandfathering" of EU centrally authorised
    medicines to UK MAs
  • Medicines and medical devices availability and stockpiling
  • UK/Australia pre-Brexit deal will facilitate trade of medicines and medical devices

International

  • IFPMA's latest Code of Practice bans gifts and promotional aids
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