Electronic submissions

Electronic-only submissions within the MRP, DCP, and NP are accepted in eCTD or NeeS-format for human medical products and in VNeeS -format for veterinary medical products. If an application is made in an electronic format, subsequent submissions for that product are expected in the same format (unless upgraded from NeeS to eCTD).

Current guidelines for electronic submission must be followed (see Validation below). Please observe that also PDFs not included in the eCTD or NeeS structure (e.g. mock-ups) have to be in PDF version 1.4 or above (preferably 1.4 or 1.7).

For identifying purposes, a paper copy of the cover letter included in the electronic submission should always be attached to the CD/DVD, but an original signature is not needed. The application form can be submitted in electronic format only.

Generally, signatures are not needed to be included (scanned) within the electronic submission.

If the application concerns an extension of a MA, the form “Confirmation for electronic-only submissions” (see Transition to an electronic format) should be attached in order to confirm that documentation for previously approved or submitted strengths and forms of the product will now be handled in electronic format only.

The MPA accepts that minor applications (e.g. type I variations) are sent via e-mail (use zip for eCTD, NeeS and VNeeS). Remember to set the expire date as far ahead as possible (90 days) when the document is sent via Eudralink, to reassure that it can be opened throughout the time frame that applies to the process.

If the submission is sent via e-mail, it should not be also sent by CD. If that anyway is needed (e.g. for later produced eCTD sequences), a notification should be sent with the CD to clarify that it is the same documentation already sent by e-mail, but re-sent in another format.

The MPA prefer the eCTD-format, but has currently no plans on making the eCTD mandatory unless that decision is taken jointly within the EU for MRP/DCP.

Transition to an electronic format

The first time an applicant sends a submission in an electronic format only for an already authorised product (a certain trade name) within MRP, DCP or the national procedure, it must be sent in connection with the start of a regulatory activity (such as a renewal or a variation application).

A completed form ”Confirmation for electronic-only submission” (see link on right) should be sent together with the application. This form should be attached to the paper cover letter and does not have to be included on the CD/DVD. It confirms the use of the electronic format for all current and future application documentation for the strengths and forms listed.

The MPA strongly recommends that all strengths and forms with the same name are handled in the same way, so even if the regulatory activity does not concern all strengths and/or forms of a medical product, the MPA prefers that these are included in the transition to an electronic format. The MPA system for archiving can then be change for the whole product.

To approve a transition to electronic format the MPA will carry out a technical validation of the submission and inform the applicant of the results via e-mail.

If the submission is technically invalid, the MPA will require a corrected submission to re-validate. Only technical failures should be corrected and no content should be changed.

When the application is technically valid, this will be confirmed and the MPA then expects the applicant to use electronic format only for that specific product. Once the transition has been accepted the above mentioned confirmation form do not have to be resubmitted for future applications regarding any of the listed strengths/forms.

Baseline

Product documentation previously submitted in paper format (current dossier) does not have to be submitted again in electronic format. However, the MPA recommends that applicants converting to eCTD format should reformat module 3 as a current baseline dossier and submit it as a separate sequence (preferably the first eCTD sequence, e.g. 0000), and in the cover letter confirm that it is only the format of the dossier that has changed, not its contents.  More information can be found in TIGes Harmonised eCTD guide (see link on right).

Transitions in connection with MRP or Repeat Use

If the applicant wishes to switch to an electronic format in connection with Sweden acting as RMS in an MRP or Repeat Use-procedure, the electronic dossier that is to be sent to the CMS should be sent to the MPA well before the start of the procedure. This is in order for the MPA to have time to complete a technical validation and inform the applicant of the outcome. Applicants are welcome to contact the MPA to discuss the submission, and are also referred to the guidelines on the CMD(h)’s website: ‘CMDh Best Practice guide on the use of eCTD in the MRP/DCP’ (See link on right).

Validation

An electronic application must fulfil the current ICH- and EU specifications (eCTD) as well as the harmonised EU guidelines (eCTD, NeeS and VNeeS) (see links on right). The application must always be approved by the MPA in the technical validation. Since 1 September, the new validation criteria published by TIGes at the EMA website are used.

The MPA uses the tool EURSvalidator (Extedo) for the technical validation and the application is technically approved when all Pass/Fail criteria are fulfilled. The software can be downloaded free of charge from the company website (see link on right).

When the MPA acts as RMS for a new application within the DCP or MRP we encourage the company to, before submitting to the CMSs, submit the application to the MPA for technical validation. Attach a cover letter explaining that a quick response is desired so that the application can be sent to the other countries as soon as possible. In these cases the application submitted to the MPA for validation must, of course, exactly correspond to the application to be submitted to the other countries.

eCTD (electronic Common Technical Document)

The eCTD specifications should be followed for modules 2-5 (ICH) that can be found on the ICH’s website and EU eCTD module 1 specifications found at the Notice to applicant’s website. Also, the EU guidelines found at the EMA’s webpage for eSubmissions (see links on right) should be adhered to.
During the technical validation, the MPA checks that eCTD submissions meet all the Pass/Fail criteria listed specified in the ”eCTD New Validation Criteria” v.3.1 (see link on right).

On the CMD(h)’s website you can find guidelines for the practical handling of applications in eCTD format within MRP and DCP: ’CMDh Best Practice guide on the use of eCTD in the MRP/DCP’ (see link on right). Please, be aware of that national translations should not be included in the eCTD structure.

NeeS (Non-eCTD electronic Submissions)

A NeeS-application must follow the EU guideline “TIGes Harmonised Guidance for Non-eCTD electronic Submissions (NeeS) for human medical products in the EU”, which can be found at the EMA’s website (see link on right).

During the technical validation, the MPA checks that the NeeS submissions meet all the Pass/Fail criteria listed in “NeeS Validation Criteria” v.2.1 (see link on right).

The structure and naming of files and folders in a NeeS should follow the convention that is clearly specified in the worksheet “File-Folder Structure & Names” of “NeeS Validation Criteria”.

VNeeS (Veterinary Non-eCTD electronic Submissions)

There are guidelines for electronic submissions for veterinary products on the EMA’s webpage for eSubmissions (TIGes vet): “Guideline on eSubmissions for Veterinary Products” (see link on right).

The MPA checks that submissions in VNeeS format fulfil the validation criteria that are specified in the guidance. The MPA uses the “VNeeS Checker” for technical validation of VNeeS submissions that are linked from that same website (se link on the right).

Active Substance Master File (ASMF)

The MPA also accepts electronic submissions for ASMF documentation from ASMF holders. The same format requirements as for medical products apply (see above). A paper copy of the cover letter should be submitted with CD/DVD but no signature is needed.

The submissions will be technically validated and if the technical requirements are not met a corrected CD/DVD will be requested. When the electronic format is accepted by the MPA the ASMF holder will be informed and afterwards all incoming documentation for that ASMF dossier is expected to be submitted in electronic format only.

In accordance with current EU guidelines, the format of ASMF documentation does not have to be the same as the format of the medical products referring to the ASMF, but it is of course expected that the documents in the open part fully correspond in content regardless of format.

For applications for medical products where the open part of the ASMF documentation is included in an eCTD, NeeS or VNeeS, the EU guidelines should be followed. The ASMF documentation that is included in the submission for the medical product should be in the same format as the rest of that submission, and is therefore independent of the format that the ASMF holder has chosen.

For more information on how ASMF documentation should be handled in eCTD format please refer to the document “Practical Guidelines on the Use of the eCTD Format for ASMFs for Active Substance Master File Holders and Marketing Authorisation Holders” which can be found under “Documentation” on the EMA’s website (see link on right). This guide is also useful as a basis for making an ASMF submission in NeeS format.

Paper submissions

Submissions in paper format will continue to be accepted by the MPA, even if use of the electronic format (eCTD, NeeS or VNeeS) is strongly recommended. An electronic copy of the paper submission should anyway be attached to facilitate the assessment. This electronic submission would only be regarded as a copy and will therefore not be technically validated by the MPA. The applicant is however expected to make a transition to electronic format as soon as possible.

Additional information

Always attach Word copies of the Product Information (SmPC, PL and labelling, with “tracked changes” if relevant) and Module 2 (for submissions within the national procedure or when Sweden is the RMS in DCP/MRP).

Word files are only working copies and should be placed outside the electronic submission structure, but included on the same CD/DVD in a separate folder labelled ”working documents”.

Only one set of CD/DVDs per submission should be sent to the MPA. Each submitted CD/DVD should be clearly labelled in accordance with current EU guidelines for electronic submissions (see above). If several submissions are submitted at the same time for the same medical products these should be combined on the same CD/DVD, but each eCTD/NeeS/VNeeS should have a unique folder structure and the disc should be clearly labelled with all included submissions.

We recommend the use of the cover letter template recommended by the CDM(h) for applications within MRP/DCP (see the link on the right to the HMA’s website). The template is also recommended for national submissions to the MPA.

PDF files should normally be created from electronically written documents in order to ease searching and copying the document, and should only in exceptional cases be scanned. In order to facilitate the assessment work, please check that cut and paste from PDF files to Word documents results in an editable format.

More information regarding practical administration of submissions can be found in “Practical guidance for submission of applications” (see link on right).

Test validation

If the applicant wishes, the MPA can do a technical validation in advance on planned electronic submissions and send the results to the applicant. The cover letter must clearly state that it is a test submission for technical validation and provide an e-mail address where the test results can be sent. Response will normally be given within two weeks.