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 GOD-Validering@dkma.dk

Updated: 17 October 2019

Case No# Start of procedure Phase
2017063360 01-08-2017 2nd Evaluation
2017063360 01-08-2017 Closing phase
2017081375 28-11-2017 2nd Evaluation
2018010307 15-02-2018 2nd Evaluation
2018041402 18-04-2018 2nd Evaluation
2018041402 18-04-2018 Closing phase
2018081721 20-08-2018 2nd Evaluation
2018081726 20-08-2018 1st Evaluation
2018081732 20-08-2018 1st Evaluation
2018081739 20-08-2018 1st Evaluation
2018081743 20-08-2018 1st Evaluation
2018092806 11-10-2018 2nd Evaluation
2018060357 22-10-2018 2nd Evaluation
2018090374 07-11-2018 1st Evaluation
2018123286 21-01-2019 2nd Evaluation
2018100151 30-01-2019 2nd Evaluation
2019013193 27-02-2019 1st Evaluation
2018114564 05-03-2019 2nd Evaluation
2018092191 07-03-2019 2nd Evaluation
2019034212 28-03-2019 2nd Evaluation
2019034214 28-03-2019 2nd Evaluation
2019030446 01-04-2019 1st Evaluation
2019022710 04-04-2019 1st Evaluation
2018113954 11-04-2019 1st Evaluation
2018113975 11-04-2019 1st Evaluation
2018114067 11-04-2019 1st Evaluation
2019024133 24-04-2019 2nd Evaluation
2019043651 30-04-2019 Closing phase
2019041485 07-05-2019 2nd Evaluation
2019043685 08-05-2019 2nd Evaluation
2019042433 15-05-2019 2nd Evaluation
2019020034 20-05-2019 2nd Evaluation
2019042631 24-05-2019 1st Evaluation
2019052364 27-05-2019 1st Evaluation
2019050238 04-06-2019 2nd Evaluation
2019050280 04-06-2019 2nd Evaluation
2019051898 09-06-2019 2nd Evaluation
2019060149 11-06-2019 2nd Evaluation
2019060153 11-06-2019 2nd Evaluation
2019054002 14-06-2019 1st Evaluation
2019054424 14-06-2019 1st Evaluation
2019030633 18-06-2019 2nd Evaluation
2019060368 21-06-2019 2nd Evaluation
2019061195 24-06-2019 1st Evaluation
2019062650 25-06-2019 2nd Evaluation
2019062650 25-06-2019 Closing phase
2019062651 01-07-2019 1st Evaluation
2019070515 05-07-2019 1st Evaluation
2019060949 22-07-2019 Closing phase
2019060960 22-07-2019 1st Evaluation
2019040268 26-07-2019 Closing phase
2019071926 26-07-2019 1st Evaluation
2019062917 02-08-2019 2nd Evaluation
2019052367 05-08-2019 2nd Evaluation
2019063201 13-08-2019 2nd Evaluation
2019063252 15-08-2019 2nd Evaluation
2019080026 15-08-2019 2nd Evaluation
2019070330 16-08-2019 2nd Evaluation
2019072142 16-08-2019 1st Evaluation
2019021741 19-08-2019 1st Evaluation
2019073840 19-08-2019 2nd Evaluation
2019064010 20-08-2019 2nd Evaluation
2019064017 20-08-2019 2nd Evaluation
2019070082 20-08-2019 2nd Evaluation
2019070902 20-08-2019 2nd Evaluation
2019070929 21-08-2019 2nd Evaluation
2019062431 22-08-2019 1st Evaluation
2019063241 22-08-2019 2nd Evaluation
2019073350 22-08-2019 Closing phase
2019071147 23-08-2019 2nd Evaluation
2019074198 23-08-2019 1st Evaluation
2019071920 27-08-2019 2nd Evaluation
2019081925 27-08-2019 2nd Evaluation
2019080033 29-08-2019 2nd Evaluation
2019080535 30-08-2019 2nd Evaluation
2019073475 02-09-2019 Closing phase
2019072151 03-09-2019 1st Evaluation
2019073345 03-09-2019 1st Evaluation
2019080763 03-09-2019 2nd Evaluation
2019081754 04-09-2019 2nd Evaluation
2019063989 09-09-2019 2nd Evaluation
2019081276 09-09-2019 1st Evaluation
2019081340 09-09-2019 1st Evaluation
2019081756 09-09-2019 2nd Evaluation
2019074112 10-09-2019 2nd Evaluation
2019073478 13-09-2019 2nd Evaluation
2019074148 13-09-2019 2nd Evaluation
2019080206 13-09-2019 2nd Evaluation
2019081346 13-09-2019 2nd Evaluation
2019081751 13-09-2019 2nd Evaluation
2019082374 13-09-2019 1st Evaluation
2019083451 13-09-2019 1st Evaluation
2019090049 13-09-2019 2nd Evaluation
2019071946 20-09-2019 2nd Evaluation
2019080739 20-09-2019 2nd Evaluation
2019081255 20-09-2019 1st Evaluation
2019081274 20-09-2019 2nd Evaluation
2019081518 20-09-2019 2nd Evaluation
2019081745 20-09-2019 2nd Evaluation
2019054427 23-09-2019 1st Evaluation
2019054545 23-09-2019 1st Evaluation
2019082889 23-09-2019 1st Evaluation
2019083156 23-09-2019 1st Evaluation
2019073469 24-09-2019 2nd Evaluation
2019083823 25-09-2019 1st Evaluation
2019083824 25-09-2019 1st Evaluation
2019090053 29-09-2019 1st Evaluation
2019073459 30-09-2019 2nd Evaluation
2019072555 01-10-2019 2nd Evaluation
2019073451 01-10-2019 2nd Evaluation
2019062595 02-10-2019 1st Evaluation
2019073462 02-10-2019 2nd Evaluation
2019093355 02-10-2019 1st Evaluation
2019094305 03-10-2019 1st Evaluation
2019094354 03-10-2019 1st Evaluation
2019063042 04-10-2019 1st Evaluation
2019070154 04-10-2019 1st Evaluation
2019073161 04-10-2019 1st Evaluation
2019073162 04-10-2019 1st Evaluation
2019073348 04-10-2019 1st Evaluation
2019090792 04-10-2019 1st Evaluation
2019091387 04-10-2019 1st Evaluation
2019092094 04-10-2019 1st Evaluation
2019092660 04-10-2019 1st Evaluation
2019093645 04-10-2019 1st Evaluation
2019100037 07-10-2019 1st Evaluation
2019094303 09-10-2019 1st Evaluation
2019094365 09-10-2019 1st Evaluation
2019094373 09-10-2019 1st Evaluation
2019100049 09-10-2019 1st Evaluation
2019100258 09-10-2019 1st Evaluation
2019094331 11-10-2019 1st Evaluation
2019060645 14-10-2019 1st Evaluation
2019101189 15-10-2019 1st Evaluation
2019101190 15-10-2019 1st Evaluation
2019090031 21-10-2019 1st Evaluation

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