ANNEX IIREQUIREMENTS REFERRED TO IN POINT (B) OF ARTICLE 8(1)32

TITLE IIIRequirements for specific marketing authorisation applications

5.Informed consent applications

Applications based on Article 13c shall contain the data described in Part 1 of Title 1 of this Annex, provided that the marketing authorisation holder for the original veterinary medicinal product has given the applicant his consent to refer to the content of Parts 2, 3 and 4 of the dossier of that product. In this case, there is no need to submit quality, safety and efficacy detailed and critical summaries.