Since 28 January 2022, the BVL only accepts electronic submissions of documents for authorisation and registration procedures for veterinary medicinal products and their follow-up procedures.

The BVL accepts electronic submissions via the Common European Submission Platform (CESP).

Applications are accepted for purely national procedures and for decentralised procedures as well as for their follow-up procedures (variation procedures). In addition to authorisation procedures, national procedures also include parallel trade, registrations for homeopathic veterinary medicines, exemptions from the need to obtain a marketing authorisation according to section 4 TAMG, and approval of trials in accordance with section 10 TAMG. Active Substance Master Files (ASMF) are also accepted via CESP.

Submissions for centralised authorisations and their subsequent procedures are made via the eSubmission Gateway and the eSubmission Web Client.

Notes on eSubmission

The European Medicines Agency provides further information on eSubmission on the Veterinary eSubmission homepage. The format and content of electronic submissions are defined in the "Guideline on eSubmissions for Veterinary Products". The guideline contains information on submission media, file formats, folder structures, tables of content, linking of content, etc.

More Information on electronic submission and a link to the “cover letter template for new MA applications” can be found below this text in the "Further information" section.

On the Veterinary eSubmission homepage, you will also find a free tool for the technical validation of electronic submissions: the VNeeS Checker. Please note that in accordance with the "Guideline on eSubmissions for Veterinary Products", applicants should carry out the technical validation before submission and include the result in the dossier.

The documentation uploaded via the Common European Submission Platform (CESP) undergoes technical validation at the BVL. The applicant may have to make technical corrections. Please note that the time slot allocated to your procedure in accordance with the Regulation (EU) 2019/6 can only be considered begun when a technically valid submission is received. It is therefore strongly recommended that you check the documentation prior to submission in accordance with the guideline. If the result of the technical validation is positive, you will receive a confirmation message.

In order to use the Common European Submission Portal, registration on the CESP website is required. In addition to general information, the CESP website also provides comprehensive material with instructions for submitting applications (online training material).

The submission of application documents in paper form is no longer possible.