News

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

Health apps insight

New rules on health research and health data research projects

New ENLI guide on information material and medical devices

EMA updates user guide for SMEs in the pharmaceutical sector

Good news for sponsors of combination studies involving both drugs and IVD medical devices

Help is at hand: New guidelines for medical device software

The Danish Medicines Council publishes new guidelines for alternative contract models

New practice on naming medicines

Proposals for new Pharmaceutical Legislation

The European Court of Justice delivers a new judgement on wholesale distribution of medicines