Paragraph 7 Bibliographic applicationE1

An applicant for a marketing authorisation need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials F1if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety.

Sub-paragraph (1) does not apply to applications for—

The applicant may use any publicly available document.

If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies, together with further clinical trials, a third party may not use those studies or trials in an application for a pharmacologically equivalent product for a period of three years from the grant of the authorisation for the additional species.