Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more
9/25/2020
/ Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
UK ,
UK Brexit
We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness of AI, a consumer whistleblowing...more
11/1/2019
/ Appeals ,
Artificial Intelligence ,
Class Action ,
Court of Justice of the European Union (CJEU) ,
Cybersecurity ,
EU ,
Evidentiary Standards ,
Global Market ,
Medical Devices ,
Punitive Damages ,
Regulatory Agenda ,
Restaurant Industry ,
Retail Market ,
UK ,
Whistleblowers
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
2/14/2019
/ Biotechnology ,
Commercial Marketing ,
EU ,
European Commission ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Oversight ,
UK ,
UK Brexit
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
2/7/2019
/ EU ,
Foreign Manufacturers ,
Healthcare ,
Imports ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Sales & Distribution Agreements ,
Supply Chain ,
UK ,
UK Brexit
In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a "common rulebook" between the parties in relation to goods....more
On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance,...more