Electronic marketing authorisation submissions

Electronic marketing authorisation submissions

General

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.

Electronic applications

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

  • 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 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 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 file.

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.

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).

Further information

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.