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Welcome to the February 2020 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:

Global

  • The Coronavirus outbreak: disrupting the global supply chain

Europe

  • Innovation Network launches a new pilot programme for Simultaneous National Scientific Advice to foster prompt regulatory support on innovation with medicines and medical devices.
  • Is the Falsified Medicines Directive the solution to managing drug shortages? 

EU - Brexit

  • What do healthcare clients need to know?
  • Brexit update: the development of a "UK Global Tariff"

Belgium

  • New law combatting medicines shortages reinforces the supply obligation for wholesalers and expands notification rules

Czech Republic 

  •  New law ensures the availability of pharmaceuticals on Czech market
  • New amendment to Pharmaceuticals Act introducing the supply obligation of MAHs

Netherlands

  •  New Dutch pharma code of conduct
  • Reform of the medicines reimbursement system

Poland

  • National plan for rare diseases awaits adoption by the government
  • Vague wording of the amendment to the Pharmaceutical Law

Russia

  • The procedure for determining drug interchangeability has been changed
  • Further development of track and trace serialization system in Russia
  • The rules for mandatory re-registration of the registered maximum selling prices of medicines included in the ED List in 2019-2020 have been approved

Slovak Republic

  • Strengthening of rules restricting the re-export of pharmaceuticals
  • Simpler rules for pharmaceuticals with lower consumption rates
  • New rules for price referencing of pharmaceuticals

Spain

  • Valencia issues rules on medical device facilities

Ukraine

  • Ukraine healthcare regulations: 2019-2020 key changes
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