Procedure for e-submission
Electronic documentation regarding marketing authorisation, renewal or variation can be submitted in a CD or DVD format or via e-mail signed with a secure digital signature.
Electronic documentation regarding marketing authorisation, renewal and variation can be submitted in the following way:
Option No. 1
Via the following e-mail address paula.jakobsone@pvd.gov.lv (files up to 30 Mb in size) validated with a secure digital signature * (created using a secure digital signature formation method and confirmed with a certificate).
Option No.2
In a compact disc (CD-R, CD-RW) or DVD format submitted together with following documents signed in a paper format:
- Cover letter;
- Application for marketing authorisation, renewal or variation.
Documents for electronic submission
Documentation | VNeeS/ eNtA | Language | No. of electronic copies | |
Marketing authorisation | Parts I-IV | √ | EN/LV | 1 |
Additional documentation | √ | EN/LV | 1 | |
Renewal of marketing authorisation | Parts I-IV | √ | EN/LV | 1 |
Additional documentation | √ | |||
Variation | Parts I-IV | √ | EN/LV | 1 |
Additional documentation | √ | EN/LV | 1 |
Paper copies should be submitted on the request of FVS.
Paper copies of documentation is still accepted.
*Circulation of electronic documents in the Food and Veterinary Srevice is ensured according to the Regulation of the Cabinet of Ministers No.473 "Order of drafting, forming, storing and circulation of electronic documents in state and municipal institutions and order how the circulation of electronic documents within state and municipal institutions or between these institutions and natural or legal persons takes place" and "The Electronic Documents Law".
The full information regarding the structure of the electronic documentation is available at European Medicines Agency's website: http://esubmission.ema.europa.eu/tiges/vetesub.htm
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