Electronic submissions

All submissions related to marketing authorisation applications for medical product are expected to be submitted in electronic format only.

In accordance with the EU eSubmission Roadmap, it is mandatory within all EU procedures to use eCTD format for human medicinal products and VNeeS for all veterinary medicinal products. For national procedures, the MPA will also follow the EU eSubmission Roadmap, meaning that new applications for marketing authorisation are expected in eCTD- and VNeeS format only from 1 July 2018, and for all post-approval submissions from 1 January 2019.

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 (Link under External links).

For frequently updated information on the electronic formats and the EU eSubmission Roadmap with timelines for mandatory eCTD, VneeS and a new format for eAF, please refer to the eSubmission website.

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 to new format
Baseline
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) can be downloaded from the eSubmission website (EMA) website (link under External links). Always make sure to use the current version. The eAF should always be submitted in locked format, with a so-called signature.
On the same webpage you can also find information about the eAF, how to lock the form as well as regulatory and technical user guides.

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).

Exceptions

The CMDh eCTD BPG 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
  • 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 the following procedures; MRP, DCP and national submissions. There is no nominal size limit for submissions to minimize bandwidth zipping is a requirement.

The CESP is reached via the HMA CESP web page (link under External links). 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- and veterinary 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.

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).

Switch to new format

Any dossier format change to eCTD, or VNeeS format should preferably be made in conjunction with the submission of a variation, renewal application or other new regulatory activity, but will also be accepted for submissions of responses and/or supplementary information. Any dossier format switch is assumed to apply for all strengths and formulations of a medicinal product sharing the same trade name, if not otherwise justified. 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 and all future submissions should be handled in that new format.

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 (link under External links).

Baseline

When switching to electronic format, there is no requirement for reformatting the documentation previously submitted 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 has not 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 (Link to eSubmission expert group document website under External links).

Active Substance Master File (ASMF)

ASMF documentation referring to an application in the centralised, decentralised or mutual recognition procedures or to new MA applications in the national procedure must be sent in eCTD or VneeS format.

The ASMF submission will be technically validated by EU technical validation criteria and if invalid a technically revised submission will be required.

For more information on ASMF submissions in eCTD format, please consult the guidance document "EU Harmonised Technical Guidance for ASMF Submissions in eCTD format" in the "eASMF" section of the EMA eSubmission website (link under External links).

 
 

Contact us

Contact person: Andreas Dillner, Kristina Anfält or Marie-Louise Pichl 
Information administrators
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:
eSubmission@lakemedelsverket.se

 

Related information

 

External links

   
 

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