An application for exemption from the marketing authorisation requirement must be submitted electronically using the application form provided by the BVL.

You can find the application form here.

The BVL accepts applications for exemption of pet medicinal products via the Common European Submission Portal (CESP). The CESP homepage provides information on submission, extensive training materials and support services.

In order to use the Common European Submission Portal, registration on the CESP homepage is required.

Instructions for electronic submission can be found here.

Required documents

The application form shall contain the following information: Information on target species, route of administration, active substances and package sizes, as well as the information required for the Union product database in accordance with Implementing Regulation (EU) 2021/16.

The application must also be accompanied by drafts of the product information (information on the outer packaging and immediate packaging (labelling) and on the package leaflet) in accordance with Section 5(1) TAMG as well as proof of the applicant's registered place of business in the EEA.

You can find forms and templates for the application here. 

Contact during the application process

Inquiries or requests regarding submitted exemption applications are made by the BVL by e-mail to the contact address stated in the application form. If no declaration of consent is given for direct correspondence by e-mail (see section 2.3.2. of the application form), the correspondence on the part of the BVL is sent out via Eudralink using the e-mail address provided for the applicant in section 2.3.1. of the application form. If the applicant does not have an Eudralink account, a password must be provided with the application form. This passwort can then be used to open the Eudralink messages sent by the BVL. These e-mails also trigger deadlines for defect rectification.

Information on the procedure can be obtained via the following e-mail address: tam-freistellung@bvl.bund.de