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Technical guidance to applicants for dossier submission

As of 2014, dossiers are to be submitted in the format specified in the respective EU Guidance Document (Document SANCO/10181/2013- rev. 2.1, 13 May 2013). This Guidance Document also includes information on how to adapt the Annex points to the new data requirements.

In addition, the BVL provides guidance on dossier submission. Most of the documents are available in English only.

Guidance of the BVL

Information is given here on the submission of dossiers, the necessary number of copies and the arrangements for the completeness check ("turbo-check"):

Two clicks for more safety: The element will be activated only after operating the slide control. Data protection information: By activating this external link you will leave the BVL website. We have no influence on the contents of the following website, in particular not on the protection of your personal data. For more information please see our data protection declaration, which you can find here.

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