FI: Fimea reduces paper requirements for electronic submissions

The Finnish Medicines Agency Fimea announced today that the Agency started to accept electronic submissions for new applications as well as variations and renewals without requesting further printed copies on 1st April, 2011.

After this date the only paper documents required are:

• Cover Letter
• Signed Application Form (or copy of it)
• Technical eCTD / NeeS Validation Report
• Proof of Payment
• Confirmation for eSubmission (in case of the first electronic submission, required separately for each marketing authorization)

In this context, "electronic submissions" cover human medicinal products submitted in eCTD or NeeS format and veterinary medicines submitted as VNeeS. For other formats and in case of parallel import product related submissions, a paper copy still needs to be provided. 

In light of the last update from Fimea from end of last year (see related News article), this further significant reduction in administrative burden for applicants comes somewhat surprisingly early but will be appreciated all the more.

[Source: Fimea website]

Related News:

 Finnish Medicines Agency reports high percentage of electronic submissions received in the first year - 23.08.2011 10:24

 FI: FIMEA updates electronic submission requirements and mandates electronic submissions - 30.12.2010 16:55

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