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Welcome to the October 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

• General presumption of confidentiality of clinical study reports: Opinion of AG Hogan in Case C-175/18 P, PTC Therapeutics International Ltd v European Medicines Agency (EMA)
• Medical Device Regulations: publication of rules on designation of expert panels
• Orphan drug designation: the EU Court of Justice position


Europe - Brexit

• The Status of "retained EU law" Repeal of the European Communities Act
• Can no-deal Brexit stockpiled drugs be sold out of the UK?


Italy

• New draft decree on pricing of medicinal products
• Medical devices: designation of the first Italian notified body
• Functional equivalence between medical devices with different durations


Turkey

• TÄ°TCK announces updates and improvements for ÜTS


United Kingdom

• Expansion of the streamlined single submission pilot for clinical trials
• UK maintains its global edge for clinical trials ahead of Brexit
• Aspen offers to pay GBP 8 million compensation to NHS as part of settlement with UK Competition & Markets Authority
• MHRA enhances the quality of biological medicines
• All-Party Parliamentary Group Report: Recommendations for NICE's upcoming methods review
• UK Focus: Cannabis-based Drug for Childhood Epilepsy Approved for Use in the UK


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