| ARTICLE 51: |
Adoption of decisions under dossier evaluation |
1. The
Agency shall notify its draft decision in accordance with Articles
40 or
41, 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
Agency 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(3).
8. An appeal may be brought, in accordance with Articles
91,
92 and
93, against
Agency decisions under paragraphs 3 and 6 of this Article.