Special characteristics of the electronic marketing authorisation process for veterinary medicines
Special characterics of the electronic marketing authorisation process for veterinary medicines
The primary format for Marketing Authorisation applications for veterinary medicines is VNeeS. Applications in the veterinary procedures must be submitted to Fimea via CESP portal or regular mail.
If the Applicant uses regular mail, the whole material should be submitted in paper and additionally on a CD/DVD disc.
In addition to the application material itself, the submission must contain
- A copy of the signed cover letter and application form in PDF 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 or via Eudralink.
- a technical validation report (recommendation)
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).
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 files via regular mail or via CESP. The size of an individual document must not exceed 100 MB.
If the documents are submitted via regular mail, Part 1 and 2 shall also be submitted as a single paper copy and the whole material in electronic format on CD/DVD disc. Non-standard material should be accompanied with a description, such as a table of contents, containing details down to individual file names.
Sunset Clause applications can be submitted in non-standard format as electronic submissions. 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.
Timetable: Moving to vNeeS format
- 2017 vNeeS compulsory in CP, MRP and DCP
- 1.7.2018 New National MA applications only in vNeeS
- 1.1.2019 All National applications in vNeeS
Fimea follows the guideline of HMA eSubmission Roadmap
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