Medicinal products, intermediates and active substances.
Order on medicinal product emergency response for the management of coronavirus disease 2019 (COVID-19).
The Order enables the Minister for Health in Denmark to activate the medicinal product emergency response in association with management of COVID-19 and its knock-on effects in Denmark.
Activation of the medicinal product emergency response gives the Danish Medicines Agency the powers, after a specific assessment – depending on the scope of the Minister's activation – with regard to medicinal products, intermediates and active substances, to order Danish pharmaceutical companies to report all information on stocks, increase stocks, distribute stocks in a specified manner, and prohibit the distribution of stocks, as well as establish detailed trading conditions for distribution. The Danish Medicines Agency is also granted powers to order the rationing of medicinal products from pharmacies and retailers that are licensed to dispense non-prescription medicinal products. Lastly, the Danish Medicines Agency is granted powers – in emergency response situations involving COVID-19 – to order that medicinal product prices may not increase by more than a specified percentage; the Danish Medicines Agency may even set specific prices.
The Danish Medicines Agency may only use these powers where proportional to ensure the health and life of humans and animals.