Chwilio Deddfwriaeth

Commission Regulation (EC) No 1451/2007 (repealed)Dangos y teitl llawn

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (Text with EEA relevance) (repealed)

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Article 13Completeness check of dossiers

1.Within three months of receiving the dossier for an existing active substance/product type combination and no later than three months after the end of the relevant time period specified in Article 9(2) of this Regulation, the Rapporteur Member State shall verify whether the dossier is to be accepted as complete in accordance with Article 11(1)(b) of Directive 98/8/EC.

Where the Rapporteur Member State has initiated consultations with other Member States and the Commission in relation to the acceptability of a dossier, the period may be prolonged until consultations have been finalised, up to a maximum of six months from receipt of the dossier.

2.A Rapporteur Member State may require, as a condition for considering a dossier to be complete, proof of advance payment, in full or in part, of the charges payable under Article 25 of Directive 98/8/EC to be provided in the dossier.

3.Where a dossier is considered to be complete, the Rapporteur Member State shall confirm acceptance of the dossier to the participant and agree to the participant forwarding the summary dossier to the Commission and the other Member States within one month of receiving the confirmation.

If a Member State in receipt of a summary dossier has legitimate reason to believe that the dossier is incomplete, it shall without delay communicate its concerns to the Rapporteur Member State, the Commission and the other Member States.

The Rapporteur Member State shall immediately take up consultations with that Member State and the Commission in order to discuss the concern expressed and resolve divergent opinions.

4.In exceptional circumstances, the Rapporteur Member State may establish a new deadline for the submission of information which, for reasons duly substantiated, the participant was unable to submit in due time.

The participant shall, within three months of being informed of the new deadline, provide evidence to the Rapporteur Member State that work to provide the missing information has been commissioned.

If the Rapporteur Member State considers that it has received sufficient evidence, it shall carry out its evaluation in accordance with Article 14 as if the dossier were complete. Otherwise, the evaluation shall not commence until the missing information is submitted.

5.Where a complete dossier is not received within the period specified in Article 9 or by a new deadline established in accordance with paragraph 4, the Rapporteur Member State shall inform the Commission, giving the reasons put forward by the participant by way of justification.

The Rapporteur Member State shall also inform the Commission in cases where a participant fails to provide the evidence required in accordance with the second subparagraph of paragraph 4. In the cases referred to in the first and second subparagraphs and if no other dossier concerns the same existing active substance/product type combination, all participants shall be deemed to have withdrawn and Articles 11(2) and 12 shall apply mutatis mutandis.

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