8. E-Submission

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. So, if you don't hear anything from us you can consider your submission technically valid.

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?

The eCTD format is mandatory for applications for new medicinal products for human use in the decentralised and mutual recognition procedure and the VneeS format is mandatory for all applications concerning medicinal products for veterinary use within the DCP and MRP procedure.

In accordance with the EU eSubmission Roadmap the eCTD and VneeS format will become mandatory for all types of submissions concerning both medicinal for human and veterinary use in DCP, MRP and national application. For more information on the upcoming dates please see Electronic 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.

 Electronic submissions to the MPA (left-hand column).

 
 

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Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information