Article 18 - Generic veterinary medicinal products - of Regulation (EU) 2019/6, states that, by way of derogation from point (b) of Article 8(1), it shall not be required that an application for a marketing authorisation for a generic veterinary medicinal product contain the documentation on safety and efficacy if three specific conditions are fulfilled.
One of these conditions is the demonstration of bioequivalence.
Where bioequivalence cannot be demonstrated through bioavailability studies and a waiver is not applicable, a hybrid application under Article 19 should be submitted.
The demonstration of safety and efficacy in the context of an Article 19 application where bioequivalence to a reference veterinary medicinal product cannot be demonstrated may require the submission of significant technical documentation. Applicants are advised to discuss with the competent authorities as to the appropriate technical documentation that should be provided in this scenario.