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Welcome to the November 2019 edition of the EMEA Healthcare & Life Sciences Industry Group Newsletter, your regular digest of legal developments affecting the life science and healthcare industries across the region.

In this issue:

Czech Republic

  • Czech Republic amends legislation on pharmaceuticals despite MoH criticism 

Europe

  • Start International Horizon Scanning Initiative (IHSI) 
  • Public procurement for the supply of medical devices and CE marking 
  • EU Medical Device Coordination Group publishes guidance on the qualification and classification of software
  • Launch of EUDAMED database delayed by two years 

Europe Brexit 

  • EMA relocation - a few months on 
  • How might Brexit affect the duty of continuous supply of medicinal products in the UK?
  • DHSC requires pharma and medtech companies to maintain their no-deal readiness for January 2020

Germany

  • Germany passes Digital Care Act: E-health apps to become reimbursable
  • Germany prepares to implement MDR

Italy

  • "Pharmacies of Services": the Agreement between Italian state and regions
  • Italian Medicine Agency publishes the 18th National Report on Clinical Trials of Medicines
  • Italian Medicine Agency's report on pharmaceutical expenditure in the first four months of 2019
  • New predicate offences listed in legislation impact on pharma and biomedical companies

The Netherlands

  • Soft transition of FMD implementation has ended in the Netherlands
  • Report from the Dutch Healthcare Inspectorate on inducements related to medical devices
  • Cloud storage of patient data reviewed by Dutch DPA and found GDPR compliant
  • Conditional authorization of medicines for rare diseases

Poland

  • Draft legislation to implement MDR/IVMDR regulates advertising to the public
  • Poland implements the Falsified Medicines Directive

Russia

  • Russian EDL and other lists of medicines for 2020 approved
  • Further development of the track and trace serialization system in Russia
  • Russia amends rules on medicines for veterinary use

Turkey

  • Cosmetics safety: Turkey continues cracking down on unsafe and noncompliant cosmetic products
  • Amendments to the Communiqué on Healthcare Practices

United Kingdom

  • Contractors working in Healthcare in the UK face greater tax scrutiny and new rules
  • The legal hurdles in using patient data for product development
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