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.

• Document SANCO/10181/2013- rev. 2.1, 13 May 2013: Guidance document for applicants on preparing dossiers

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"):

• Submission of dossiers (new)
• Submission of dossiers (resubmission and renewal)
• EU Peer Review - Number of dossier copies to be submitted to Germany
• Technical arrangements for the turbo check
• EU Review of active substances - Frequently asked questions of applicants