CHAPTER II

MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS
Section 5

Specific requirements for generic, hybrid and combination veterinary medicinal products and for applications based on informed consent and bibliographic data

Application based on informed consent
Article 21
By way of derogation from point (b) of Article 8(1), an applicant for a marketing authorisation for a veterinary medicinal product shall not be required to provide the technical documentation on quality, safety and efficacy if that applicant demonstrates permission, in the form of a letter of access, to use such documentation submitted in respect of the already authorised veterinary medicinal product.