Presentation of a draft directive or draft decision
Article 11
1. Without prejudice to any proposal it may submit with a view to amending the Annex to Council Directive 79/117/EEC ( 7 ) , the Commission shall, at the latest six months after receipt of the conclusion of the Authority or information that the applicant has failed to submit the missing elements to the dossier, submit to the Committee a draft review report to be finalised at its meeting. The applicant shall be given the possibility to submit comments on the review report within a deadline set by the Commission. 2. On the basis of the review report provided for in paragraph 1, and taking into account any comments submitted by the applicant within the deadline set by the Commission under paragraph 1, a Directive or a Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of the Directive 91/414/EEC, providing that: (a) an active substance is included in Annex I to Directive 91/414/EEC subject to conditions and restrictions, where appropriate; (b) an active substance is not included in Annex I to that Directive. 3. The adoption of a decision under paragraph 2(b) shall end the assessment of that active substance under this Regulation.