Via DKMAnet, on CD-ROM (accompanied by a duly signed cover letter on paper, sent by regular mail) or via Eudralink
(1) DKMAnet: DKMAnet is a shared portal for applications for clinical trials on medicinal products to both authorities, the Danish Health and Medicines Authority and the Scientific Ethical Committee System. Companies, including CROs can apply for authorisation of clinical trials and submit notifications about ongoing trials to DKMAnet.
Further info are provided on website in Section: Medicines & medical devices / Medicines regulation / Clinical trials / Trials in humans / Applying via DKMAnet.
(2) Eudralink: the documentation shall be sent to email@example.com. Application for Eudralink account: Email to firstname.lastname@example.org.
It provides 4 services:
(1) Application for new clinical trial authorisation (CTA)
(2) Application to amend an authorised clinical trial
(3) Safety surveillance of authorised clinical trial, such as:
Annual safety reports (ASR/DSUR), change of trial status (end, temporarily halted, or premature closure), other safety-related information.
(4) Notification about authorised clinical trial, such as: Final report, trial extension, new trial sites, change of PI or coordinating investigator, other notifications.
NB! In future, use of DKMAnet will be mandatory. Exact date not yet decided.