Fimea starts accepting e-submissions including variations and renewals without printed copies on 1st April, 2011

Fimea starts accepting e-submissions including variations and renewals without printed copies on April the 1st, 2011. After this date no other paper documents need to be sent to us than the cover letter, signed application form or a copy of it, the technical validation report of an eCTD/NeeS submission, a receipt of payment and the Confirmation for eSubmission in case of the first electronic submission. The confirmation is required separately for each marketing authorization along with the first e-submission. E-submissions cover both human and veterinary medicines, and earlier instructions given on these web pages apply to them. A paper copy of parallel import product related submissions, submissions in other formats than eCTD, NeeS or VNeeS and ASMF documents is, however, still required.

For further information please contact us at esubmission-info@fimea.fi.