Instructions for electronic marketing authorisation submissions

Materials outside the eCTD and NeeS/VNeeS 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/VNeeS structure (working documents). They can also be submitted as is by email (Eudralink).

Application formats

The recommended format for applications for medicinal products intended for human use is eCTD. Alternatively, they applications can be submitted in the NeeS format. Applications for veterinary medicines must be in the VNeeS format. The file format in the application must conform to the EMA guideline; i.e. the file format must be PDF 1.4.

The cover letter, application form, proof of payment and validation report shall be sent as separate PDF documents outside the eCTD, NeeS and VNeeS structure.

At any time, the applicant can switch over from NeeS to eCTD, which is the recommended format. However, a return from the eCTD format to the NeeS format is not possible.

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, NeeS and VNeeS structure.

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

Documents to be submitted on paper

A paper copy must still be submitted for parallel-import products and ASMF documents. Paper copies cannot be submitted via CESP. Instead they must be submitted on a DVD or CD-ROM. Signed documents do not have to be the original ones (wet signature), a PDF printout is sufficient.

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, application form and proof of payment. The cover letter and the application form do not have to be the original ones. If this is the first electronic application for the marketing authorisation, the application materials must contain a notification of transfer to the electronic application procedure (confirmation of initiating the electronic submission procedure).

Applications submitted via CESP and eGateway do not need an accompanying DVD or CD ROM nor paper documents. However, the submitted materials must contain scans of the aforementioned documents, signed. However, Fimea may request that you submit the application on a DVD or 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 ASMF documents or clinical trial materials. PSUR and RMP materials can be submitted via CESP.

Applications belonging to the centralised procedure must be submitted by the EMA eGateway and Common Repository.

Confirming electronic submissions

The cover letter of the first electronic application of a medicinal product must state that the applicant shifts to electronic submissions for the medicinal product. An example of the statement: “We hereby notify that starting from the data of this application, xx.xx.xxxx, we will use electronic submissions for this medicinal product (trade name, strength, packaging format).” Fimea recommends using the CMD Cover Letter template and its Free Text field for this purpose.

The notification must be made separately whenever a marketing authorisation application is submitted electronically for the first time. Once electronic submissions are initiated, a return to paper submissions is not possible.

Shifting to electronic submissions

The shift to electronic submissions can be done at the start of the marketing authorisation application process, or, subject to certain preconditions, during the process. The preconditions are published on the EMA electronic submission site.

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.

Submitting electronic materials Submitting electronic materials