How often should supplementary information provided?
Fimea must be immediately notified of any changes to your organisation’s information. In the event that a new responsible person or a substitute has been appointed, approval for the appointment must be sought within 7 days.
Regular applicants must supply additional information where the last information was supplied more than 6 months ago and no comments were received from Fimea. In this instance, the information must be re-submitted in whole or in part using Appendix 2. Appendix 2 allows applicants to clearly highlight where changes have taken place and to certify that no changes, other than those already stated, have taken place. Please note that self-certificates signed by members of the board and responsible persons under Appendices 1 and 3 must be provided on each occasion.
In summary: all three appendices must be submitted every six months. In addition to the signed appendices, further information is only required if changes have been made to the information previously submitted.