Submission of supplementary dossiers
Article 9
1. Where the rapporteur Member State has informed the applicant in accordance with Article 6(2) that its application fulfils the requirements of Articles 4 and 5, the applicant shall submit to the rapporteur Member State and the co-rapporteur Member State a supplementary summary dossier and a supplementary complete dossier, hereinafter ‘the supplementary dossiers’. The supplementary dossiers shall be added to the dossiers submitted for the first inclusion, with their subsequent updates, hereinafter ‘the original dossiers’. 2. The contents of the supplementary dossiers shall comply with Article 10. 3. The supplementary dossiers shall be submitted by the date set out for the respective active substance in column D of Annex I. 4. At the request of the Authority or a Member State, the applicant shall make available the original dossiers where it has access to them. 5. Where there is more than one applicant requesting renewal of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly. Where dossiers are not submitted jointly by all applicants concerned, the reasons shall be set out in the dossiers. For each study involving vertebrate animals, the applicants concerned shall detail the attempts made to avoid duplication of testing and justify, if applicable, the need for conducting a duplicate study.