News

Trial Nation publishes new guide aimed at improving recruitment of participants for clinical trials

ENLI increases fees & fine levels and launches a new notification system

Hearing on new draft executive order on medicinal products subject to mandatory stockpiling and reporting obligations for critical medicinal products

Reprocessing and further use of single-use medical devices to be permitted?

New EU guidance clarifies the new notification obligation in case of interruption or discontinuation of supply of medical devices

News on market exclusivity for orphan medicinal products

New changes to the Danish Wholesale Distribution Authorisation application form effective from November 2024

New Danish Initiatives to Boost Pharmaceutical Production and Streamline Approvals

European Parliament Resolution Urges Immediate Reforms to Medical Device Regulations

AI: Shaping the future of law – Join Plesner and the Association of Danish Law Firms's new training program

Medical devices: The European Commission updates timelines for the implementation of EUDAMED

New EMA pilot programme for orphan medical devices

Bill on mandatory stockpiles of critical medicines, etc. passed

New guideline on advertising, etc. on medical devices adopted

New EU regulation with relevance for cancer medicines and ATMP medicines

Medicinal products without a Danish marketing authorisation can now be prescribed and dispensed

Upcoming new guideline on advertising, etc. of medical devices - draft going out for consultation

The Danish Medicines Agency has designated a new Danish body for certification of medical devices

The Treatment Council is to be closed down - tasks are transferred to a new institute

The Danish Medicines Council introduces agreed application dates and a new process for validation of applications