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Commission Regulation (EU) No 188/2011Dangos y teitl llawn
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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- Rheoliadau yn deillio o’r UE
- 2011 No. 188
- Article 11
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Nodweddion Uwch
- Dangos Graddfa Ddaearyddol(e.e. Lloegr, Cymru, Yr Alban aca Gogledd Iwerddon)
- Dangos Llinell Amser Newidiadau
Dewisiadau Agor
Rhagor o Adnoddau
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Article 11U.K.Transitional measures
1.Articles 2, 3 and Article 4(1) shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which the application was received by the rapporteur Member State by 17 March 2011 but for which no completeness check had been made by that date.
For such applications the rapporteur Member State shall perform the completeness check provided for in Article 4(1) by 18 June 2011 at the latest.
2.Articles 2, 3 and 4 shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which the dossier was referred to the Committee in accordance with Article 6(2) of that Directive by 17 March 2011 but for which no completeness decision had been adopted by that date.
For such applications a completeness decision shall be adopted in accordance with Article 6(3) of Directive 91/414/EEC by 18 July 2011.
3.Articles 2, 3 and 4 shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which a completeness decision was adopted but not published by 17 March 2011.
4.Articles 2 to 6 shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which a completeness decision was published by 17 March 2011 but no draft assessment report had been submitted to the Commission by that date.
For such applications the rapporteur Member State shall prepare and submit the draft assessment report to the Commission, with a copy to the Authority by 18 March 2012. 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. Article 6(2) to (5) shall apply mutatis mutandis.
5.Articles 2 to 6 and the first subparagraph of Article 7(1) shall not apply to applications for which the draft assessment report had been received by the Authority but not circulated to the applicant and the other Member States for comments by 17 March 2011.
6.By way of derogation from paragraph 5, for applications for which the draft assessment report had been submitted to the Commission and the Authority by 31 December 2009 at the latest, Articles 2 to 6 and the first subparagraph of Article 7(1) shall not apply. In such cases, the following procedure shall apply.
By 18 April 2011, the rapporteur Member State shall request the applicant to inform that Member State and the Authority, within 1 month, in case the applicant considers that information that had not been submitted for the preparation of the draft assessment report and that might influence the outcome of the assessment, is available, specifying the nature of that information and its possible influence on the assessment.
Within 2 months from receiving the reply of the applicant, the Authority shall decide whether that information might influence the outcome of the assessment. If so, the Authority shall, without undue delay, ask the rapporteur Member State to request the submission of that information by the applicant. The rapporteur Member State shall update the draft assessment report where appropriate in the light of that information.
The Authority shall set a period of up to 6 months for the rapporteur Member State to prepare and submit to the Commission that updated draft assessment report, with a copy to the Authority. 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. Article 6(2) to (5) shall apply mutatis mutandis, whereby the period referred to in the first subparagraph of Article 6(3) shall not exceed 3 months.
7.The Commission shall set, and publish on its website, the dates for the circulation of the draft assessment reports referred to in paragraphs 5 and 6. Where a draft assessment report has been updated, as provided for in paragraph 6, it shall be circulated as updated. The Commission shall at the same time set, and publish on its website, the dates for the submission of comments thereon.
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