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Commission Regulation (EU) No 188/2011Show full title
Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (Text with EEA relevance)
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Changes over time for: Article 8
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Article 8U.K.Conclusion by the Authority
1.Within 4 months from the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion on whether the active substance can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public.
Where appropriate, the Authority shall address in its conclusion the risk mitigation options in relation to the intended uses set out in the draft assessment report.
2.The Authority shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State.
In that case the 4-month period for the adoption of the conclusion, as set out in paragraph 1, shall be extended by 2 months.
3.Where the Authority needs additional information, it shall, in consultation with the rapporteur Member State, set a period of a maximum of 3 months for the applicant to submit that information to the Member States, the Commission and the Authority. It shall inform the applicant, the Commission and the Member States. In respect of applications for which a completeness decision was published by 31 December 2005, the maximum period shall be 5 months.
4.Within 2 months after receipt of the additional information the rapporteur Member State shall assess that information and submit an addendum to the draft assessment report to the Authority. In respect of applications for which a completeness decision was published by 31 December 2005, that period shall be 3 months.
5.Where the Authority requests additional information in accordance with paragraph 3, the period from the date of that request to the date of the submission of the addendum to the draft assessment report shall not be taken into account for the calculation of the period for the adoption of the conclusion, as provided for in paragraphs 1 and 2.
6.In its conclusion the Authority shall only take into account additional information requested by it or by the rapporteur Member State and submitted within the period granted.
7.The Authority shall establish the format for its conclusion which shall include details concerning the appraisal procedure and the properties of the active substance concerned.
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