Special characteristics of the electronic marketing authorisation process for veterinary medicines
Marketing authorisation applications for veterinary medicines must comply to the standardised VNeeS format. Applications in the VNeeS format can be submitted to Fimea online via the CESP portal or, in exceptional cases, on a CD or DVD disc (two identical copies).
In addition to the application itself, the application materials must contain
- A copy of the signed cover letter and application form in PDF 1.4 format. In case the application has been submitted on a CD or a DVD, the signed cover letter and application form should also be submitted in paper format.
- the SPC and package leaflet in an editable format, such as MS Word outside the VNeeS structure (working documents) or separately by email (Eudralink)
- a technical validation report, including the validation tool and version, if the technical validation has been performed before submitting the documents
- notification of a transfer to the electronic process, if this is the first electronic application
The application form to use is the EMA’s electronic application form (eAF) like for medicinal products for human use (mandatory in the centralised procedure starting from 1 July 2015 and in other EU procedures starting from 1 January 2016). Attach the form to the application materials as a copy in PDF 1.4 format.
Responses during the VNeeS procedure (marketing authorisation, variation or renewal procedure) must be submitted via the CESP portal or in exceptional circumstances on two identical CDs or DVDs.. To ensure smooth processing, we also wish to receive the responses by email (Eudralink). The size limit is 80 MB.
In exceptional cases where it is impossible to create a marketing authorisation application in the VNeeS format, the applicant may submit the application in a non-standard electronic format. In this case, the application documents shall be sent as PDF 1.4 files on a CD or DVD (two copies) or via CESP. The size of an individual document must not exceed 100 MB. If the documents are submitted on a CD or DVD, Part 1 and 2 shall also be submitted as a single paper copy. Non-standard material should be accompanied with a description, such as a table of contents, containing details down to individual file names.
In some applications, such as small variations or referral procedures, it is possible to submit a standardised electronic application, even if the application is not of the VNeeS format. Likewise PSURs can be submitted electronically, even if they are not in the VNeeS format.
Fimea accepts VNeeS applications whose quality section is conforms to the CTD format. The same applies for ASMF materials.