Electronic submissions

The Swedish Medical Products Agency (MPA) strongly urges applicants to make all their submissions of medicinal product documentation in electronic format, as this allows us to work more efficiently.

In accordance with the EU eSubmission Roadmap, the eCTD format will be mandatory for all EU procedures for human medicinal products from 1 January 2018. For EU procedures for veterinary medicinal products, the VNeeS format has been mandatory since 1 January 2017. For national procedures, the MPA will follow the EU eSubmission Roadmap, meaning that new applications for marketing authorisation will have to be made in eCTD/VNeeS format from 1 July 2018, and all post-approval submissions will follow suit from 1 January 2019.

Information on each of the three electronic submission formats that are accepted in the EU can be found on the EMA website "eSubmission" (see link to the right). The EU eSubmission Roadmap includes dates from which each of these three formats are mandatory:

  • For human medicinal products, the eCTD format is mandatory for all applications for marketing authorisation via DCP and MRP since 1 July 2015 and 1 January 2017 respectively, and
  • from 1 January 2018, the eCTD format is mandatory for all post-approval submissions in MRP as well
  • For veterinary medicinal products, the VNeeS format is mandatory for all submissions in DCP and MRP

For ongoing MR procedures for human medicinal products started prior to 2018 for which the documentation was sent in another format than eCTD, please consult the document "Q&A on Mandatory eCTD in MRP and how to manage changes to eCTD format during ongoing procedures" for details on how to handle the format change (see link to the right).

The EU eSubmission Roadmap also includes dates from which the eCTD and VNeeS formats will be mandatory for national procedures. For new applications for marketing authorisation, the eCTD and VNeeS formats will be mandatory from 1 July 2018, and for all other submissions from 1 January 2019

For more information on the EU eSubmission Roadmap and the introduction of mandatory eCTD, VNeeS, eAF and a new solution in CESP, see the EMA eSubmission website. We recommend applicants to keep themselves updated through the EU eSubmission site as there is a lot happening within this field.

Bookmarks for this page:

Technical requirements and validation
Guidance documents and other aids
Using the CESP
Using the eSubmission Gateway/Web Client
Using EudraLink
Using CD/DVD
Paper-based dossiers
Switch from paper-based submission to e-submissions
Active Substance Master File

Four ways to send an electronic submission to the Swedish Medical Products Agency

  1. Using the CESP – recommended by the Medical Products Agency for all types of applications not uploaded via the eSubmission Gateway/Web Client. Zipping is required.
  2. Using EudraLink - a complete eCTD, NeeS, or VNeeS will have to be zipped in order for the folder structure to remain
  3. Using email – can be used for submissions no larger than 20 MB. Aa complete eCTD, NeeS, or VNeeS will have to be zipped in order for the folder structure to remain
  4. Using CD/DVD -refrain from zipping the content

NOTE! Use only one of the above for each submission since duplicate submissions will cause the MPA unnecessary extra work.

Please observe that submissions for centralised procedures should always be sent only via the eSubmission Gateway/Web Client. This applies to all documentation submitted as part of the EU Single Assessment Procedure as well. We will access and download this documentation via the EMA ourselves.

Cover letter template

The Swedish Medical Products Agency recommends applicants to use the CMDh cover letter template for all submissions made for DCP/MRP (see link to the HMA website to the right). It is also recommended to use the template when submitting national applications to the Medical Products Agency.

The Swedish Medical Products Agency does not require an original signature or a scanned signature on neither the application form nor the cover letter. However, the applicant should always lock the electronic application with a so-called signature (see below).

Electronic application form

The electronic application form (eAF) should be used for the application types that have one. The eAF should always be sent electronically, so even if other documentation is submitted in paper format the eAF must be attached electronically (on disc).

Please note that the eAF should always be sent to us locked (with a so-called signature).

The eAF can be downloaded from the EMA website on eAF (see link to the right), always make sure to use the current version. There you can also find more information about the eAF and how to lock the form.

PDF files

All PDF files should normally, when possible, be created from electronic text documents (e.g. Word). To facilitate the assessment, applicants should ensure that all PDF files allow for text to be fully editable after copying, so that they can easily be used when we write our assessment reports.

Working documents

The product information (SmPC, PL, labelling) should always be included as Word copies (with tracked changes when applicable). For submissions in the national procedure and when Sweden acts as RMS in a DCP/MRP, Word copies of included Module 2 documents are greatly appreciated, as we frequently copy text and tables from these into our assessment reports.

The Word files should be placed outside the submission folder structure, in a separate folder named "xxxx-working documents".

Technical requirements and validation

All electronic submissions (eCTD, NeeS and VNeeS) must comply with current ICH and/or EU requirements and pass the technical validation performed by the Medical products Agency against current validation criteria (see links to the ICH and the EMA eSubmission website to the right).

All Pass/Fail criteria must be met for a submission to be accepted.

Guidance documents and other aids

Guidance and validation criteria documents for each format can be found on the EMA eSubmission website. In addition, there is a separate guide for eCTD submissions in MRP and DCP:"CMDh Best Practice guide on the use of eCTD in the MRP/DCP" (see link to the right).

If you need to build a NeeS manually, the Module 2-5 folder structure is available for download from the ICH website. The EU Module 1 folder structure can be downloaded from the Medical Products Agency website (see link to the right); note that this contains country and language folders only for Sweden and "common". Consult the EU eCTD Module 1 specification for file and folder naming rules (the naming rules can also be found on a separate tab of the eCTD and NeeS validation criteria documents, available on the EMA eSubmission website).


The CMDh eCTD BPG (see link to the right) clarifies that no eCTD sequence is required for the following national submission types:

  • Change of MAH
  • Change of local agent
  • Dose dispensing
  • Sunset Clause
  • New mock-ups
  • Legal status
  • National notifications for a pack size in a CMS, which is already included in the core SmPC of the MRP dossier
  • National notifications to remove/add an already approved indication, due to patent usage in a CMS

For all submission types above, documentation can be sent to the Medical Products Agency as PDF files without folder structure. They must still comply with the file level requirements – i.e. PDF 1.4 or higher and with no security settings enabled. The Medical Products Agency accepts the same handling for NeeS and VNeeS dossiers.

Please note that national translations of product information should always be placed outside the eCTD/Nees folder structure - in a separate folder called "working documents" along with an application, or as separate Word files through email/EudraLink if it is a supplement to an ongoing case.

Using the CESP

The Swedish Medical Products Agency recommends applicants to use the common platform for submissions made to the EU agencies, the CESP. It can be used for electronic submissions for all procedures (MRP, DCP, national submissions and for submissions regarding veterinary medicinal products through the CP). There is no nominal size limit for submissions (it has been tested for 10 GB); to minimize bandwidth zipping is a requirement. As with other e-submissions to the MPA, only eCTD, NeeS, and VNeeS submissions are accepted via the CESP. It should not be used for electronic copies of submissions made for paper based dossiers; these copies should always come on CD/DVD together with the documentation on paper.

The CESP is reached via the HMA CESP web page (see link to the right). In order to use the CESP, you must first register on the CESP web page. The portal includes a self-service feature, which requires each company to assign one administrator, who in turn assigns and manages user accounts to other people in the organization. Note that there is a separate form to use for registration of the administrator, accessible via the same link on the CESP website. The Medical Products Agency recommends all new users of the CESP to participate in the free webinars offered regularly.

The Swedish Medical Products Agency would like to emphasize the importance of not submitting duplicate documentation. If documentation is resent the comments field should always be used to clarify why the documentation is being sent again including a reference to the previous CESP-submission.

If the documentation for an MRP product is only to be sent to one specific CMS the RMS "zz" should be specified, in order to avoid the RMS receiving a copy of the documentation.

Using the eSubmission Gateway/Web Client

Any submission of documentation for human medicinal products in the Centralised Procedure, PSUR documentation assessed within the EU Single Assessment, as well as Referral procedures not handled by the CMDh/CMDv, should be made only via the eSubmission Gateway/Web Client. Any such submission sent to the Medical Products Agency in any other way will be discarded – we will download the documentation from the Common Repository/PSUR Repository. Documentation for veterinary medicinal products in the centralised procedure should be uploaded to the eSubmission Gateway/Web Client, but must also, for the time being, be sent separately to the Medical Products Agency via some other channel, preferably the CESP.

For information on the eSubmission Gateway/Web Client, consult the EMA website (see link to the right).

Using EudraLink

EudraLink is a secure file transfer solution provided by the EMA. To use the service you must first register for a EudraLink account through the EMA website (see link to the right). The registration form should be sent to https://servicedesk.ema.europa.eu. Any submission containing folders (e.g. eCTD, NeeS and VNeeS) must be zipped in order for it to reach the recipient(s) in the intended structure. There are no size restrictions for a submission. However, individual files must not exceed 200 MB, if they do they need to be zipped, and folders exceeding 200 MB must be divided into zip archives.

Ensure that all submissions have an expiry date of at least 30 days.

Using CD/DVD

When sending documentation on CD/DVD, the Medical Products Agency needs only one copy of each disc. Discs must be clearly labeled in accordance with current EU e-submission guidelines. If multiple submissions for a product are made at the same time, these should preferably be contained on one single disc. Each submission must still have a separate folder structure, and the disc should be labeled with all submissions it contains.

You can find additional information on various practical aspects with submissions on the page "Practical guidance for submissions" (see link to the left).

Paper-based dossiers

Documentation for a paper-based dossier should be submitted electronically. The EU e-submission formats are strongly recommended, but until the eCTD and VneeS formats are mandatory the MPA will accept other electronic formats. These should be structured in a logical fashion, based on the CTD/NtA structure, and all files should preferably be in PDF 1.4 or higher.

The applicants are expected to switch paper-based dossiers to an EU e-submission format (eCTD, Nees, VNeeS) as soon as possible. For products handled in MRP and the national procedure there are set dates for mandatory eCTD and VNeeS.

Switch from paper-based submissions to e-submissions

For nationally approved medicinal products, the Swedish Medical Products Agency still accept other submission formats than eCTD/VNeeS (see dates for mandatory eCTD/VNeeS above). The Swedish Medical Products Agency encourages applicants to make all submissions in electronic format, even for dossiers initially submitted on paper (a so called paper-based dossier).

Any dossier format change from paper to eCTD, NeeS, or VNeeS should preferably be made in conjunction with the submission of a variation renewal application, PSUR or other new regulatory activity, but will also be accepted for submissions of responses and/or supplementary information. Alternatively, a switch can be made at any point in the dossier lifecycle by submitting a "baseline" dossier (see below).Unless otherwise agreed, any dossier format switch is assumed to apply for all strengths and formulations of a medicinal product sharing the same trade name. Thus, even if the submission initiating the format switch only concerns some of all dossiers with the trade name, they will all be encompassed by the switch.

A technical validation of the submission will be made. If the submission does not pass this validation, the Swedish Medical Products Agency will request a technically revised submission. All future submissions made will be expected to be in the same format.


When switching submission format from paper to one of the EU e-submission formats, there is no requirement for reformatting any documentation previously submitted only on paper. However, to facilitate assessment the Swedish Medical Products Agency recommends that dossiers that are switched to eCTD format start the lifecycle with a collection of all currently valid Module 3 documents as a so-called baseline. This reformatted documentation should be sent as a unique sequence (normally 0000), with the cover letter clarifying that the contents have been previously assessed and that the only change made is the dossier format.

A baseline can also be submitted later in the dossier lifecycle, adding valid documentation that hasn't yet been submitted in eCTD format. Here too, the documentation must be sent as a unique sequence (with the next available sequence number in the lifecycle), together with a clarification in the cover letter that no new information is included, but only the format is changed.

Please consult the EU Harmonised technical eCTD guidance for further information on Baseline submissions (see link to the EMA eSubmission website to the right).

Active Substance Master File (ASMF)

The Medical Products Agency prefers ASMF documentation from the ASMF holder in electronic format. ASMF documentation referring to human medicinal products in the centralised, decentralised or mutual recognition procedures must be sent in eCTD format. ASMF documentation referring to human medicinal products in national procedure should be sent to the Swedish Medical Products Agency electronically, prefeably in eCTD format.

Any electronic ASMF documentation submission will be technically validated. If the electronic submission is found to be in compliance with the EU e-submission technical validation criteria, the ASMF holder will be informed that the Swedish Medical Products Agency will expect all future submission for the ASMF dossier in the same format.

As clarified by the current EU guidance documents, the format of the ASMF dossier does not need to be the same as the format of any medicinal product dossier referencing the ASMF.

For more information on ASMF submissions in eCTD format, please consult the "EU Harmonised Technical Guidance for ASMF Submissions in eCTD format version 2.0" guidance document in the "eASMF" section of the EMA eSubmission website. This guidance document is generally applicable to ASMF NeeS submissions as well, though certain technical details will differ.


Contact us

Contact person: Mattias Boman
Information administrator
Phone: +46 18 17 26 74 

If you have questions on electronic submission or would like validation response on eCTDs, please send an e-mail to:


Related information


External links


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