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||Adoption of decisions under dossier evaluation
1. The Agency
shall notify its draft decision in accordance with Articles 40
, together with the comments of the registrant, to the competent authorities of the Member States
2. Within 30 days of circulation, the Member States
may propose amendments to the draft decision to the Agency
3. If the Agency
does not receive any proposals, it shall take the decision in the version notified under paragraph 1.
4. If the Agency
receives a proposal for amendment, it may modify the draft decision. The Agency
shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the
end of the 30-day period referred to in paragraph 2.
5. The Agency
shall forthwith communicate any proposal for amendment to any registrants or downstream users
concerned and allow them to comment within 30 days. The Member State Committee shall take any comments received into account.
6. If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, the
shall take the decision accordingly.
7. If the Member State Committee fails to reach unanimous agreement, the Commission shall prepare a draft decision to be taken
in accordance with the procedure referred to in Article 133
8. An appeal may be brought, in accordance with Articles 91
, against Agency
decisions under paragraphs 3 and 6 of this Article.