The Finnish Medicines Agency FIMEA has published the requirements on electronic submissions of marketing authorisation material starting from the 1st of January 2011 (see link at the bottom of this article).
Starting January 2011, Fimea will use an electronic-only marketing authorization process. This means that from this day onward Fimea will only accept applications in electronic format and all submissions (marketing authorization applications, variations, renewals, PSURs, ASMF) concerning human medicinal products including traditional herbal medicinal products, must be submitted electronically. (Please note: parallel import procedures are excluded). All veterinary product submissions must also be submitted to Fimea electronically.
Applicants should send submissions to Fimea in standard EU eCTD or NeeS format. In addition to the electronic versions, modules 1–3 will still need to be submitted as paper copies due to national archiving requirements.
A complete submission comprises:
- the original cover letter incl. “Confirmation for eSubmission”
- the eCTD / NeeS technical validation report (as an appendix to the cover letter)
- two sets of the electronic submission (in eCTD/NeeS format, SPC and PL in Word format)
- one paper printout of modules 1–3
Exceptional ("non-standard") submission procedures may be accepted in case applicants are not able to provide valid eCTD or NeeS. In that case a complete paper copy of Module 1-5 must be provided accompanied by two sets of electronic files of the complete submission. Files must be PDF 1.4 and should not exceed 100 MB file size. In the corresponding cover letter of the submission it must be clearly indicated that the application is ”non-standard”, i.e., that the application is submitted by the exceptional procedure. Exceptional procedures are not available for new marketing authorization applications in the national procedures. The provision of additional electronic files in the exceptional procedure is a mandatory requirement as Fimea currently operates in several different locations.
Fimea’s processing times for such "non-standard" submission applications may be longer compared with submissions provided in EU eCTD or NeeS formatdue to separate processes and tools required. Furthermore, Fimea points out that at the next review of the application fees these may call for an increase in fees for the “non-standard” applications in comparison to standard eCTD/Nees applications.
[Source: FIMEA website]
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