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Welcome to the July 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:

Europe

  • New EU measures boost the generic pharmaceuticals industry
  • Falsified drugs from Italy reach UK patients five months after the EU Falsified Medicines Regime went live

Europe – Brexit

  • EMA settles into its new Dutch home whilst still battling its UK tenancy obligations in the courts Dutch relocation
  • Brexit Select Committee Hearing – impact on the pharmaceuticals industry
  • LRQA withdraws Notified Body services: is the industry ready for the MDR / IVDR and a no-deal Brexit?

Germany

  • Apps on prescription?

Italy

  • New decree on clinical trials approved
  • Council of State rules in favour of public hospital in medical equipment tender case
  • Council of State dismisses biomedicine company’s tender appeal over latest generation devices
  • The exclusion of a medicinal product from a tender is legitimate when the same product is only relevant for its “off-label” use

Kazakhstan

  • Kazakhstan adopts Ethical Rules for the promotion of pharmaceutical products and medical devices

Poland

  • Joint initiative of V4 and Lithuania for fair prices of medicine
  • Amended regulations regarding the opinion on purposefulness of healthcare investments

Russia

  • New law empowers government to require drug price reductions
  • Further development of the track-and-trace serialisation system in Russia

Spain

  • New guide on advertising to the general public medicines for human use not subject to medical prescription

Turkey

  • Turkey introduces changes to clinical trial applications
  • Cosmetics safety: Turkey continues cracking down on unsafe and noncompliant cosmetic products

UK

  • Legal basis for processing personal data in clinical trials – what’s the right approach?
  • NHS Digital’s new Internet First Policy
  • Simplified hospital credentialing process for Medtech industry staff: MIA and LSI combine operations