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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 6
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Article 6U.K.Assessment by the rapporteur Member State
1.Within 12 months from the date of publication of the completeness decision, the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to fulfil the conditions provided for in Article 5 of Directive 91/414/EEC, hereinafter referred to as ‘draft assessment report’. It shall at the same time inform the applicant that the draft assessment report has been submitted and request him to immediately forward to the Authority, the other Member States and the Commission the updated dossiers, where applicable.
2.The rapporteur Member State may consult the Authority.
3.Where the rapporteur Member State needs additional information, it shall request it from the applicant setting a period of up to 6 months for it to be supplied. The rapporteur Member State shall inform the Commission and the Authority. In its assessment the rapporteur Member State shall only take into account information which was requested and submitted within the period granted.
In cases where the rapporteur Member State requests additional information, the 12-month period provided for in paragraph 1 for the submission of the draft assessment report shall be extended by the period granted by the rapporteur Member State for the submission of the additional information. If the requested information is submitted to the rapporteur Member State before the end of the period granted the extension shall correspond to the part of that period actually used.
4.Where at the end of the period referred to in the first subparagraph of paragraph 3, the applicant has not submitted all of the additional information requested in accordance with paragraph 1, the rapporteur Member State shall inform the applicant, the Commission, the other Member States and the Authority and shall state the missing elements in the draft assessment report.
5.If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit elements necessary for the assessment referred to in paragraph 1, it shall adopt a decision in accordance with Article 9(2)(b), providing that the active substance concerned is not to be included in Annex I to Directive 91/414/EEC.
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