Is it a medicine? Is it a device? It can be both, says EU court
This article was originally published in Clinica
Executive Summary
In a ruling that may come as some surprise to those on both sides of the drug/device divide, the Court of Justice of the EU has ruled that a product can be classified as a medicinal product in one member state and as a medical device in another, and thus be subject to different sets of legislation.
You may also be interested in...
Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages
The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.
EU Countries Offered Funding To Contribute to African Regulatory Strengthening
Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.