Instructions for electronic marketing authorisation submissions

eCTD and NeeS

The recommended format for applications for medicinal products intended for human use is eCTD.

It is recommended to include validation report in the submission. It should be placed outside the sequence structure.

 

Submissions and formats

Fimea follows the guideline of HMA eSubmission Roadmap.

National processes:

• 1.7.2018 New National MA applications only in eCTD

• 1.1.2019 All National applications in eCTD

MRP and DCP processes:

• 1.1.2017 New MRP/DCP MA applications only in eCTD

• 1.1.2018 all MRP/DCP processes only in eCTD

Parallel import:

• 1.7.2021 onwards CESP is compulsory for parallel import 

• Applicant should use CESP Regulatory Activity Type: Parallel Import

• paper submissions are no longer allowed

ASMF (Active Substance Master File):

• 1.1.2018 eCTD compulsory for ASMF submissions in NP, MRP and DCP

Non-standard submission is suitable for:

• national notifications (labelling – package leaflet)

• Change of MAH applications

• Sunset Clause waifers

• submitting a Swedish summary of product characteristics

CESP is recommended platform for all of these submissions.

When using regular mail, please attach cover letter in paper and complete documentation on CD/DVD.

 

Other information:

• PSUR submissions should be submitted to PSUR Repository

• CP submissions should be submitted to Common Repository

Materials outside the eCTD and NeeS format

For the national phase, the SPC and PL materials and any other national texts shall be submitted as Word documents. They shall be submitted along with the application outside the eCTD or NeeS structure (working documents). They can also be submitted via email or Eudralink.

Application storage media

The applications shall primarily be submitted via CESP or eGateway. In exceptional circumstances, the applications can be submitted on a DVD or CD ROM.

National documents

Variation applications concerning national package labelling or package leaflets, and applications concerning the transfer of marketing authorisation and registration can be submitted outside the eCTD and NeeS structure.

Changes to national documents cannot be submitted along with a NeeS application, if the documents of the product are in the eCTD format.

Submitting electronic materials

Electronic materials must always be submitted unencrypted and without password protection. This also applies to DVDs and CD-ROMs.

DVDs and CD-ROMs must be labelled according to the EU guideline. The file format and its version must also be indicated.

The DVD or CD-ROM shall be accompanied by a paper copy of the cover letter anf application form. The cover letter and the application form do not have to be the original ones.

Applications submitted via CESP and eGateway do not need an accompanying DVD/CD-ROM nor paper documents. However, the submitted materials must contain scans of the aforementioned documents, signed.

Fimea may request that you submit the application on a DVD/CD-ROM, if the application submitted via CESP is defective or faulty, and does not pass technical validation. Like any applications, applications e-submitted via CESP must be complete wholes, and may not be supplemented later. The comment field of the CESP cover file must describe the content of the submission.

CESP cannot be used to submit materials that must be submitted as paper copies, such as non-format ASMF documents or Clinical Trial materials.

Applications belonging to the Centralised Procedure must be submitted by the EMA eGateway and Common Repository.

The electronic application form (eAF)

Starting from 1 June 2015, the use of an EMA electronic application form (eAF) is mandatory for applications submitted for the centralised procedure. For other EU procedures, the eAF form will be mandatory from 1 January 2016 onwards. Forms created with the eAF shall be attached to the applications as a PDF 1.4 file.

Technical validation

The applicant must perform a technical validation to the application to ensure that the application is technically functional and complies to standards. The technical validation is carried out as specified in the EMA validation criteria in force at the time of the application. The technical validation report, supplemented with information on the validation tool used, shall be added to the application materials and sent to Fimea. The report must also specify the version of the validation criteria, if the validation criteria will change in the near future.

If the application is rejected in Fimea’s verification validation, Fimea will ask the applicant to resubmit the application. In these cases, Fimea’s technical validation report is sent to the applicant to help with the corrections.