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: 23 April 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
2017120959 05-01-2018 2nd Evaluation
2017120959 05-01-2018 Closing phase
2018010307 15-02-2018 2nd Evaluation
2018011810 19-02-2018 2nd Evaluation
2018041402 18-04-2018 2nd Evaluation
2018041402 18-04-2018 Closing phase
2018051642 18-06-2018 2nd Evaluation
2018060060 18-06-2018 2nd Evaluation
2018081721 20-08-2018 1st 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
2018082414 23-08-2018 2nd Evaluation
2018060047 03-09-2018 2nd Evaluation
2018091563 19-09-2018 Closing phase
2018091336 20-09-2018 2nd Evaluation
2018091314 25-09-2018 2nd Evaluation
2018091737 28-09-2018 2nd Evaluation
2018100466 08-10-2018 2nd Evaluation
2018092806 11-10-2018 2nd Evaluation
2018100460 11-10-2018 2nd Evaluation
2018101420 15-10-2018 2nd Evaluation
2018060357 22-10-2018 2nd Evaluation
2018053206 23-10-2018 2nd Evaluation
2018061804 23-10-2018 2nd Evaluation
2018100955 25-10-2018 Closing phase
2018081736 31-10-2018 2nd Evaluation
2018052123 01-11-2018 1st Evaluation
2018101607 01-11-2018 2nd Evaluation
2018103928 06-11-2018 2nd Evaluation
2018090374 07-11-2018 1st Evaluation
2018092197 15-11-2018 Closing phase
2018103615 20-11-2018 2nd Evaluation
2018111923 22-11-2018 1st Evaluation
2018112564 27-11-2018 2nd Evaluation
2018100941 28-11-2018 2nd Evaluation
2018111916 28-11-2018 2nd Evaluation
2018111508 11-12-2018 2nd Evaluation
2018101901 13-12-2018 2nd Evaluation
2018101901 13-12-2018 Closing phase
2018103924 17-12-2018 2nd Evaluation
2018113813 17-12-2018 Closing phase
2018093735 02-01-2019 2nd Evaluation
2018122936 02-01-2019 2nd Evaluation
2018111513 03-01-2019 1st Evaluation
2018121094 03-01-2019 2nd Evaluation
2018121923 03-01-2019 2nd Evaluation
2018122175 04-01-2019 2nd Evaluation
2018123291 04-01-2019 1st Evaluation
2018104712 10-01-2019 2nd Evaluation
2018120694 11-01-2019 2nd Evaluation
2018113959 18-01-2019 1st Evaluation
2018123286 21-01-2019 2nd Evaluation
2019012014 23-01-2019 2nd Evaluation
2019012487 25-01-2019 2nd Evaluation
2018100151 30-01-2019 2nd Evaluation
2018104772 31-01-2019 2nd Evaluation
2018110541 31-01-2019 2nd Evaluation
2018122911 04-02-2019 1st Evaluation
2019014328 04-02-2019 2nd Evaluation
2019013787 05-02-2019 2nd Evaluation
2019013788 07-02-2019 1st Evaluation
2019020512 07-02-2019 1st Evaluation
2018122749 11-02-2019 2nd Evaluation
2018100932 14-02-2019 1st Evaluation
2019012250 14-02-2019 1st Evaluation
2019012250 14-02-2019 Closing phase
2019012251 18-02-2019 2nd Evaluation
2019020993 18-02-2019 2nd Evaluation
2019023287 21-02-2019 1st Evaluation
2019021469 22-02-2019 Closing phase
2019023476 25-02-2019 2nd Evaluation
2019021186 26-02-2019 2nd Evaluation
2019013193 27-02-2019 1st Evaluation
2019023465 28-02-2019 2nd Evaluation
2018122460 04-03-2019 2nd Evaluation
2018114564 05-03-2019 1st Evaluation
2019010586 05-03-2019 2nd Evaluation
2018120975 06-03-2019 1st Evaluation
2019024130 06-03-2019 1st Evaluation
2018092191 07-03-2019 1st Evaluation
2018114067 07-03-2019 1st Evaluation
2019023007 08-03-2019 2nd Evaluation
2019030151 08-03-2019 2nd Evaluation
2018111921 11-03-2019 2nd Evaluation
2019021466 12-03-2019 1st Evaluation
2019010580 13-03-2019 1st Evaluation
2018121571 18-03-2019 1st Evaluation
2019012402 18-03-2019 1st Evaluation
2019030895 18-03-2019 1st Evaluation
2019031505 18-03-2019 2nd Evaluation
2019032771 21-03-2019 2nd Evaluation
2019010364 25-03-2019 2nd Evaluation
2019021202 26-03-2019 2nd Evaluation
2019032729 27-03-2019 1st Evaluation
2019034212 28-03-2019 2nd Evaluation
2019034214 28-03-2019 2nd Evaluation
2018121914 01-04-2019 1st Evaluation
2019014815 01-04-2019 1st Evaluation
2019030446 01-04-2019 1st Evaluation
2019032965 02-04-2019 1st Evaluation
2019034530 02-04-2019 1st Evaluation
2019022710 04-04-2019 1st Evaluation
2019034236 04-04-2019 1st Evaluation
2019040260 04-04-2019 2nd Evaluation
2019040523 04-04-2019 2nd Evaluation
2019040528 04-04-2019 2nd Evaluation
2019034547 05-04-2019 1st Evaluation
2019022285 09-04-2019 1st Evaluation
2019032354 12-04-2019 1st Evaluation
2019024199 15-04-2019 1st Evaluation
2019024223 15-04-2019 1st Evaluation
2019020992 16-04-2019 1st Evaluation
2019032740 17-04-2019 1st Evaluation
2019032740 17-04-2019 2nd Evaluation
2019032740 17-04-2019 Closing phase

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