CHAPTER-4: Common provisions
ARTICLE 51: Adoption of decisions under dossier evaluation
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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.
Referred by:
ARTICLE 40: Examination of testing proposals
ARTICLE 41: Compliance check of registrations
ARTICLE 47: Coherence with other activities
ARTICLE 52: Adoption of decisions under substance evaluation
ARTICLE 91: Decisions subject to appeal
ARTICLE 135: Transitional measures regarding notified substances