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Welcome to the August 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: 

Global

  • Contradictions in cannabis: US regulatory landscape at odds with FDA's quest for data
  • The WHO adopts a resolution on pharmaceutical and healthcare market transparency

Czech Republic

  • Additional proposal to the amendment to act on pharmaceuticals

Europe

  • Publication of the new 2019 Code of Practice of the European Federation of Pharmaceutical Industries and Associations
  • Update of the manual for borderline medical device products
  • The General Court of the European Union on the requirements to obtain the orphan drug designation
  • The European Commission sets up a new information website on the EUDAMED database

Europe - Brexit

  • EU drug shortage – the impact of Brexit on both the UK and EU-27 member states

France

  • French Supreme Court held that Doctipharma website is illicit

Italy

  • The exclusion of parallel distributors from discounted tariffs granted to grouping of variations declared legitimate
  • The criterion of the lowest price applies in tender procedures for the supply of medicines with the same therapeutic indication and different concentrations of active substance
  • New rules on shortages of medicines
  • The Italian Anti-Corruption Authority publishes the fourth report on whistleblowing
  • The Italian Medicine Agency publishes the first report “Horizon Drugs - scenario of incoming medicines”
  • The seminar "Pharmaceutical and Biomedical Industry. New legislation and hot topics - 2019"  was held on June 12, 2019 in the Baker McKenzie Rome office

Russia

  • Prospective amendments to improve the procedure for determining the interchangeability of medicines

Spain

  • The Ministry of Health attempts to limit regional financing of medicinal products and medical devices
  • New stamp certifying conformity with FENIN code promotional rules for the advertising of medical devices in Spain, jointly issued by AUTOCONTROL and FENIN.

Turkey

  • TİTCK publishes guidelines for phase 1 clinical trial research centers
  • TİTCK publishes application guideline on medical gas manufacturing/filling facilities
  • TİTCK publishes guidelines for mutual recognition regarding pharmaceutical inspections
  • TİTCK announcement on EBS notifications of precursors and controlled substances
  • TİTCK Announces Amendments to the Cosmetics Regulation
  • Cosmetics Safety: Turkey Continues Cracking Down on Unsafe and Non-Compliant Cosmetic Products

United Kingdom

  • Are you using social media influencers as part of your brand strategy? The UK's ASA rules against a pharmaceutical company sponsoring an Instagram post in breach of the CAP Code
  • New private clinics offer medical cannabis in the UK
  • UK MHRA creates AI focus group
  • UK's CQC invites innovators to trial its regulatory sandbox for digital clinical triage
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