Electronic marketing authorisation submissions
Fimea requests that any submissions related to marketing authorisation applications be conducted electronically whenever possible. Electronic submissions covers almost all applications related to human and veterinary medicines and herbal remedies. These applications include new marketing authorisation applications, variation applications, renewals and PSUR reports. However, the parallel import procedure is not covered by electronic submission.
The electronic applications can be submitted in the eCTD, NeeS or VNeeS format, or, in special cases, as unstructured PDF files. Applications for the national, decentralised and mutual recognition procedure shall primarily be submitted via the CESP portal of the European pharmacovigilance network. Applications for the centralised procedure shall be submitted via the EMA’s eGateway and Common Repository.
The applications must be submitted to Fimea in an EU standard format , such as eCTD or NeeS (medicines intended for human use) or in VNeeS format (veterinary medicines). The applicant must perform a technical validation for the applications before submitting them. The complete application package (e-submission) contains
- a notification of a transfer to the electronic process, if this is the first electronic application
- the application materials in an electronic format, submitted via CESP or eGateway, or on a DVD or CD-ROM if necessary
- a signed cover letter as a PDF 1.4 file. If the application is submitted on a DVD or CD-ROM, the cover letter must also submitted as a paper copy
- the application form as an eAF-file (mandatory for centralised procedure applications and other EU procedures from 1 January 2016 onwards) or as a PDF 1.4 file. If the application is submitted on a DVD or CD-ROM, the application form must also submitted as a paper copy.
- a technical validation report as a PDF 1.4 file
- proof of payment as a PDF 1.4 file If the application is submitted on a DVD or CD-ROM, the proof of payment must also submitted as a paper copy.
For more information about the content, submission and processing of an electronic application, see the section Instructions for electronic marketing authorisation submissions on this website.
When a standard-compliant application cannot be submitted
In exceptional cases, the applicants can still submit their applications entirely on paper (modules 1–5, or, in the case of veterinary medicines. PART I–IV). Even in this case, Fimea must be submitted a precisely identical electronic copy of the paper materials, on a DVD or CD ROM as clearly named PDF 1.4 files. The maximum size for a single file is 100 MB. The cover letter of the application must state that this is a non-standard application.
The exceptional procedure does not apply to new national marketing authorisation applications. An permission to use the exceptional procedure must be requested from Fimea in advance, if the new national marketing authorisation application cannot be submitted as an electronic application complying to standards. Send the request for permission by email to e-submission-info(a)fimea.fi. Write the following as the topic of the email ”Request for submitting a new national marketing authorization application on paper”.
Applicants resorting to the exceptional procedure should remember that the processing of non-standards applications is a separate process that requires extra work on a case-by-case basis. Tus, the processing time might be longer than usual. Moreover, the processing fees might be higher than normal in the future.
Special characteristic of veterinary medicine applications
The electronic marketing authorisation applications associated with veterinary medicines are subject to the same principles as human medicines. There are, however, some special characteristics, which are described under Special characteristics of the electronic marketing authorisation process for veterinary medicines (link to the corresponding Fimea webpage).
If you wish to get more information on electronic submissions related to marketing authorisations, help in case of problems and answers to question, send an email to esubmission-info(a)fimea.fi. The EMA electronic submission website also contains a lot of general information.