Procedure Start Date for National Variations

Here you can see a table indicating when we initiated the review of each national variation in the order books. The variation will appear in the table until the case has been approved/refused. This table replaces the procedure start date letter that we used to send to applicants in connection with the initiation of a variation.

The "1st assessment" phase is the period from the procedure start date to the submission of a possible intended refusal. The "2nd assessment" phase is the period from the submission of a possible intended refusal until a decision has been made (including clock-stop days). The "Closing" phase is the period during which the decision is implemented. If an intended refusal is not given, the case passes directly from the "1st assessment" phase to the "Closing" phase".

The case number and CESP submission ID represent anonymised variation applications known only to the applicant and the Danish Medicines Agency. The case flow is within the deadlines that apply to variations after the procedure start date. The Danish Medicines Agency informs the applicant by letter when a variation has been closed. The list is updated daily.

If you have any questions or are unsure which case number to use for the table, please send an email to: Send an email