Division 1 F1
United Kingdom
The particulars and documents accompanying an application for marketing authorisation pursuant to Articles 12 to 13d shall be presented in accordance with the requirements set out in this Annex and shall take into account the guidance published by the Commission in The rules governing medicinal products in the European Union , Volume 6 B, Notice to applicants, Veterinary medicinal products, Presentation and Contents of the Dossier.