8.1 When switching submission format from paper to eCTD or NeeS/VNeeS, do we have to submit a baseline submission?
No. Baseline submissions are recommended, but not mandatory.
8.2 How do we know if an e-submission we’ve sent to the MPA is technically valid?
When an e-submission fails technical validation, we always contact the applicant with a request for a revised submission.
8.3 We have acquired an MA which was previously managed on eCTD/NeeS/VNeeS. Unfortunately, we have no means of creating eCTD:S/NeeS:s/VNeeS:s ourselves and would thus like to make submissions on paper. Is this acceptable to the MPA?
The MPA strongly recommends that an e-submission MA does not revert to a paper submission in case of an MAH transfer. Should this prove highly impractical for the new MAH, please contact us at esubmission@mpa.se for further discussion.
8.4 We currently make all submissions for a specific MA on NeeS:s. We now want to switch to eCTD submissions instead. Do we have to notify the MPA of this?
As our internal handling of eCTD:s and NeeS:s differs, we would appreciate if such a format change is mentioned in a separate passage on the first page of the cover letter for the first submission made in eCTD format.
8.5 Can we send PSUR:s electronically, without paper copies?
Yes, this is acceptable for all products, even those for which you normally submit documentation on paper. Note that if the normal submission format for the MA:s concerned is eCTD or NeeS/VNeeS, then any PSUR submission should be made in the same format.
8.6 Do we have to use the same submission format for all strengths and/or pharmaceutical forms of a specific product (i.e. sharing the same trade name)?
The MPA recommends that for ease of handling, the same submission format should be used for all MA:s of a given trade name. This is ultimately a decision for the applicant to make.
8.7 When will e-submissions to the MPA be mandatory?
There are no such plans currently, nor do we plan on making the eCTD format mandatory for e-submissions.
8.8 Do the MPA require advance notice of a format switch from paper to any of the e-submission formats?
We always need confirmation that you intend to stop submitting documentation on paper in favour of an e-submission format, otherwise we might needlessly request paper copies. This confirmation should be made together with the first e-only submission. There is a form specifically for this purpose;
Electronic submissions to the MPA (right-hand column).