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Welcome to the November 2018 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

  • EMA plans to revive its landmark clinical trials transparency policy
  • The HTA proposal: Harmonising the clinical assessment process across the EU

Czech Republic

  • Proposed changes to the regulation of vaccination

Germany

  • Impact of the new German and Austrian merger control thresholds on licensing
    agreements

Italy

  • The Italian Medicines Agency publishes the 17th Report on Clinical Trials on Medicinal Products in Italy
  • Hearing aid specialists can practice in pharmacies and para-pharmacies provided that
    they comply with technical requirements
  • The parallel importer cannot change the name of medicinal products without a just
    cause

Poland

  • The Polish government returns to the idea of reimbursement-related incentives for
    pharmaceutical investors

Russia

  • New rules for identifying a locally originating product
  • Introduction of a new system of public procurement preferences
  • Recent amendments to the procedure for determining the initial (maximum) price of a contract
  • Obligation to submit information to the Ministry of Healthcare becomes effective soon

Spain

  • Dual pricing of medicines and parallel imports in the EU: The CNMC once again
    confirms the compatibility of a dual pricing system for medicines with competition law

Turkey

  • Turkey publishes draft regulation on medical devices manufactured utilizing animal
    origin tissue
  • Cosmetics safety: Turkey continues cracking down on unsafe and non-compliant
    cosmetic products
  • Turkey publishes draft regulation on authorization of traditional herbal medical
    products
  • Turkey publishes draft regulation on foods for medical purposes
  • Turkey publishes draft regulation on medical devices
  • Turkey – Announcement on EBS access authorization changes
  • Announcement on product recall
  • Announcement on production facilities

Ukraine

  • Clinical trials
  • Public procurement and reimbursemen
  • Intellectual property
  • Competition law
  • Tax
  • Medical devices

UK

  • Transferring marketing authorizations as a result of Brexit: key tax considerations

 

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