Procedure start – National Variations

Updated 21 August 2014

Here you can see a table indicating when we initiated the individual national quality variations from the order books. The variation application will be listed in the table until the case has been closed, or until it has been authorised/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 Evaluation" phase is the period from the procedure start date to the submission of a possible intended refusal. The "2nd Evaluation" 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 Evaluation" phase to the "Closing" phase.

The case numbers 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 when searching in the table, please send an email to Send an email

Updated: 6 August 2020

Case No# Start of procedure Phase
2017063360 01-08-2017 2nd Evaluation
2017063360 01-08-2017 Closing phase
2018060357 22-10-2018 2nd Evaluation
2018090374 07-11-2018 1st Evaluation
2019013193 27-02-2019 1st Evaluation
2019034214 28-03-2019 Closing phase
2019030446 01-04-2019 2nd Evaluation
2018113954 11-04-2019 1st Evaluation
2018113975 11-04-2019 1st Evaluation
2018114067 11-04-2019 1st Evaluation
2019021741 19-08-2019 2nd Evaluation
2019072151 03-09-2019 Closing phase
2019063989 09-09-2019 2nd Evaluation
2019081276 09-09-2019 1st Evaluation
2019074148 13-09-2019 2nd Evaluation
2019081255 20-09-2019 2nd Evaluation
2019081274 20-09-2019 2nd Evaluation
2019081274 20-09-2019 Closing phase
2019081521 01-10-2019 2nd Evaluation
2019070154 04-10-2019 2nd Evaluation
2019073161 04-10-2019 2nd Evaluation
2019102897 25-10-2019 2nd Evaluation
2019093740 04-11-2019 2nd Evaluation
2019110222 12-11-2019 2nd Evaluation
2019111530 26-11-2019 2nd Evaluation
2019111609 26-11-2019 2nd Evaluation
2019121420 08-01-2020 2nd Evaluation
2019061768 13-01-2020 2nd Evaluation
2020011861 24-01-2020 2nd Evaluation
2020013976 04-02-2020 2nd Evaluation
2019112611 20-02-2020 2nd Evaluation
2020022399 20-02-2020 Closing phase
2020030456 10-03-2020 2nd Evaluation
2020031843 23-03-2020 Closing phase
2020031884 23-03-2020 2nd Evaluation
2020032496 30-03-2020 2nd Evaluation
2020033083 30-03-2020 1st Evaluation
2020030896 03-04-2020 2nd Evaluation
2020032477 16-04-2020 1st Evaluation
2020040566 19-04-2020 2nd Evaluation
2020034773 30-04-2020 1st Evaluation
2020051757 30-04-2020 1st Evaluation
2020033509 01-05-2020 2nd Evaluation
2020034090 01-05-2020 2nd Evaluation
2020042512 04-05-2020 2nd Evaluation
2020030462 07-05-2020 1st Evaluation
2020041511 12-05-2020 Closing phase
2020041512 12-05-2020 2nd Evaluation
2020051081 12-05-2020 2nd Evaluation
2020050858 15-05-2020 2nd Evaluation
2020051882 18-05-2020 1st Evaluation
2020051898 18-05-2020 2nd Evaluation
2020050433 25-05-2020 2nd Evaluation
2020052194 27-05-2020 1st Evaluation
2020052195 27-05-2020 1st Evaluation
2020053353 04-06-2020 2nd Evaluation
2020053948 04-06-2020 2nd Evaluation
2020060493 04-06-2020 2nd Evaluation
2020060324 08-06-2020 2nd Evaluation
2020060494 08-06-2020 2nd Evaluation
2020034866 10-06-2020 1st Evaluation
2020060368 12-06-2020 2nd Evaluation
2020060370 12-06-2020 2nd Evaluation
2020061627 15-06-2020 2nd Evaluation
2020061807 16-06-2020 2nd Evaluation
2020051335 18-06-2020 1st Evaluation
2020054085 18-06-2020 1st Evaluation
2020060344 18-06-2020 2nd Evaluation
2020061673 19-06-2020 1st Evaluation
2020062157 19-06-2020 2nd Evaluation
2020062199 22-06-2020 1st Evaluation
2020062484 22-06-2020 1st Evaluation
2019122209 23-06-2020 2nd Evaluation
2020061150 23-06-2020 1st Evaluation
2020062992 23-06-2020 1st Evaluation
2020061750 26-06-2020 1st Evaluation
2020061014 29-06-2020 1st Evaluation
2020062984 29-06-2020 1st Evaluation
2020060392 02-07-2020 1st Evaluation
2020060317 15-07-2020 1st Evaluation
2020060322 15-07-2020 1st Evaluation
2020061470 22-07-2020 1st Evaluation
2020061363 23-07-2020 1st Evaluation
2020070541 23-07-2020 1st Evaluation
2020054128 24-07-2020 1st Evaluation
2020054113 27-07-2020 Closing phase
2020061826 27-07-2020 1st Evaluation
2020062695 28-07-2020 1st Evaluation
2020071037 29-07-2020 1st Evaluation
2020072062 29-07-2020 1st Evaluation
2020073554 03-08-2020 1st Evaluation
2020053861 06-08-2020 1st Evaluation
2020060089 06-08-2020 1st Evaluation

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