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:
- The Coronavirus outbreak: disrupting the global supply chain
- 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"
- New law combatting medicines shortages reinforces the supply obligation for wholesalers and expands notification rules
- New law ensures the availability of pharmaceuticals on Czech market
- New amendment to Pharmaceuticals Act introducing the supply obligation of MAHs
- New Dutch pharma code of conduct
- Reform of the medicines reimbursement system
- National plan for rare diseases awaits adoption by the government
- Vague wording of the amendment to the Pharmaceutical Law
- 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
- Strengthening of rules restricting the re-export of pharmaceuticals
- Simpler rules for pharmaceuticals with lower consumption rates
- New rules for price referencing of pharmaceuticals
- Valencia issues rules on medical device facilities
- Ukraine healthcare regulations: 2019-2020 key changes