Division 2 Similar biological veterinary medicinal productsF1

In accordance with Article 13(4), where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal product, information to be supplied shall not be limited to Parts 1 and 2 (pharmaceutical, chemical and biological data), supplemented with bio-equivalence and bioavailability data. In such cases, additional data shall be provided, in particular on the safety and efficacy of the product.

• The type and amount of additional data (i.e. toxicological and other safety studies and appropriate clinical studies) shall be determined on a case-by-case basis in accordance with relevant scientific guidelines.

• Due to the diversity of biological veterinary medicinal products, the competent authority shall determine the necessary studies foreseen in Parts 3 and 4, taking into account the specific characteristic of each individual biological veterinary medicinal product.

The general principles to be applied shall be addressed in guideline which shall be adopted by the Agency, taking into account the characteristics of the concerned biological veterinary medicinal product. If the reference biological veterinary medicinal product has more than one indication, the efficacy and safety of the biological veterinary medicinal product claimed to be similar shall be justified or, if necessary, demonstrated separately for each of the claimed indications.