Ongoing Trials under the Directive and Modifications

Clinical trials with medicines must undergo an ethical review and can therefore only be conducted after approval from a research ethics committee.

After January 31, 2023, you will no longer be able to report new medicinal trials under the directive's rules.

Medicinal trials reported before January 31, 2022, will however continue to be processed by the committee that approved the trial. Supplementary protocols are to be submitted to and processed by the approving committee in a 3-year transitional period.

Ongoing trials under the directive must be administratively approved under the regulation's rules by no later than January 31, 2025. Information regarding the administrative transfer ("transition trials") can be found here: European Commission's answers to frequently asked questions about CTR (pdf) and on EMA's website, training module 23: Clinical Trials Information System (CTIS): online modular training program

How to ensure your application reaches the case handlers quickly and securely

Signed report form and project material should be sent to or by using secure mail. Important! You must indicate that the trial is for the MREC by writing "MREC" at the beginning of the subject field.

Secure mail to the MREC

If you need to send secure mail to the MREC, you must use NemID or MitID. On our contact information page, you will find links to secure mail.

Please be aware to also report to The Danish Medicines Agency.

Changes to health science research projects involving clinical trials of medicinal products may also need to be reported to The Danish Medicines Agency; find guidance on this on their website.

Last updated 01-02-2024

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