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: 8 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
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
2018092191 07-03-2019 2nd Evaluation
2019034214 28-03-2019 Closing phase
2019030446 01-04-2019 2nd 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
2019041485 07-05-2019 2nd Evaluation
2019050238 04-06-2019 2nd Evaluation
2019050280 04-06-2019 Closing phase
2019051898 09-06-2019 2nd Evaluation
2019054002 14-06-2019 2nd Evaluation
2019054424 14-06-2019 2nd Evaluation
2019060368 21-06-2019 Closing phase
2019061195 24-06-2019 1st Evaluation
2019062650 25-06-2019 Closing phase
2019070515 14-07-2019 2nd Evaluation
2019071926 26-07-2019 2nd Evaluation
2019062917 02-08-2019 2nd Evaluation
2019063252 15-08-2019 Closing phase
2019021741 19-08-2019 1st Evaluation
2019064010 20-08-2019 2nd Evaluation
2019062431 22-08-2019 1st Evaluation
2019071147 23-08-2019 2nd Evaluation
2019074198 23-08-2019 1st Evaluation
2019072151 03-09-2019 2nd Evaluation
2019073345 03-09-2019 2nd Evaluation
2019063989 09-09-2019 2nd Evaluation
2019081276 09-09-2019 1st Evaluation
2019081340 09-09-2019 1st Evaluation
2019074112 10-09-2019 2nd Evaluation
2019074148 13-09-2019 2nd Evaluation
2019080206 13-09-2019 2nd Evaluation
2019082374 13-09-2019 1st Evaluation
2019083451 13-09-2019 2nd Evaluation
2019090049 13-09-2019 2nd Evaluation
2019071946 20-09-2019 2nd Evaluation
2019081255 20-09-2019 1st Evaluation
2019081274 20-09-2019 2nd Evaluation
2019081518 20-09-2019 2nd Evaluation
2019054427 23-09-2019 1st Evaluation
2019054545 23-09-2019 2nd Evaluation
2019070327 23-09-2019 2nd Evaluation
2019070816 23-09-2019 2nd Evaluation
2019082889 23-09-2019 2nd Evaluation
2019083156 23-09-2019 2nd Evaluation
2019073469 24-09-2019 2nd 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
2019081521 01-10-2019 2nd Evaluation
2019073462 02-10-2019 2nd Evaluation
2019094354 03-10-2019 2nd Evaluation
2019063042 04-10-2019 2nd Evaluation
2019070154 04-10-2019 2nd Evaluation
2019073161 04-10-2019 2nd Evaluation
2019073162 04-10-2019 2nd Evaluation
2019073348 04-10-2019 2nd Evaluation
2019090792 04-10-2019 2nd Evaluation
2019091387 04-10-2019 2nd Evaluation
2019092660 04-10-2019 2nd Evaluation
2019093645 04-10-2019 1st Evaluation
2019094365 09-10-2019 2nd Evaluation
2019094373 09-10-2019 2nd Evaluation
2019100258 09-10-2019 2nd Evaluation
2019094331 11-10-2019 1st Evaluation
2019094393 11-10-2019 1st Evaluation
2019091135 15-10-2019 1st Evaluation
2019101022 17-10-2019 2nd Evaluation
2019063957 18-10-2019 1st Evaluation
2019090031 21-10-2019 2nd Evaluation
2019102039 24-10-2019 2nd Evaluation
2019102897 25-10-2019 2nd Evaluation
2019101592 30-10-2019 1st Evaluation
2019101877 31-10-2019 1st Evaluation
2019103137 01-11-2019 1st Evaluation
2019103956 06-11-2019 2nd Evaluation
2019104589 12-11-2019 2nd Evaluation
2019110222 12-11-2019 2nd Evaluation
2019110234 12-11-2019 2nd Evaluation
2019110301 12-11-2019 2nd Evaluation
2019110346 12-11-2019 2nd Evaluation
2019110644 13-11-2019 1st Evaluation
2019110660 13-11-2019 1st Evaluation
2019104133 14-11-2019 1st Evaluation
2019111463 14-11-2019 1st Evaluation
2019110263 18-11-2019 1st Evaluation
2019104150 19-11-2019 1st Evaluation
2019092154 20-11-2019 2nd Evaluation
2019111572 20-11-2019 1st Evaluation
2019112001 21-11-2019 2nd Evaluation
2019103523 22-11-2019 1st Evaluation
2019094366 25-11-2019 1st Evaluation
2019104406 26-11-2019 1st Evaluation
2019111530 26-11-2019 1st Evaluation
2019111609 26-11-2019 1st Evaluation
2019113098 26-11-2019 1st Evaluation
2019113810 26-11-2019 1st Evaluation
2019113845 27-11-2019 1st Evaluation
2019114120 28-11-2019 1st Evaluation
2019111452 29-11-2019 1st Evaluation
2019112613 29-11-2019 1st Evaluation
2019112779 29-11-2019 1st Evaluation
2019113166 29-11-2019 1st Evaluation
2019114215 29-11-2019 1st Evaluation
2019021743 02-12-2019 1st Evaluation
2019094319 02-12-2019 1st Evaluation
2019113714 06-12-2019 1st Evaluation
2019114683 06-12-2019 1st Evaluation

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