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CHAPTER IIU.K.ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS

SECTION 1U.K.Active substances

Subsection 2U.K.Approval procedure

Article 9U.K.Admissibility of the application

1.Within 45 days of receiving the application, the [F1assessing competent authority] shall send the applicant a written acknowledgement, stating the date of receipt, and check whether the dossiers submitted with the application contain all the elements provided for in Article 8, using the checklist referred to in point (e) of Article 8(1). It shall also check the requests for confidentiality referred to in Article 7(3) and the complete lists of tests and studies submitted pursuant to Article 8(2).

2.Where one or more of the elements provided for in Article 8 are missing, the [F2assessing competent authority] shall inform the applicant, setting a period for their submission. Such period shall be a maximum of 3 months.

Where at the end of that period, the applicant has not submitted the missing elements, the [F2assessing competent authority] shall inform the applicant [F3and the other competent authorities] that the application is inadmissible.

A new application for the same substance may be submitted at any time.

3.Where the dossiers submitted with the application contain all the elements provided for in Article 8, the [F4assessing competent authority] shall notify the applicant [F5and the other competent authorities] of the admissibility of the application and start assessing the active substance.

After receiving that notification, the applicant [F6must on request] forward the dossiers as provided for in Article 8 to the other [F7competent authorities], including the information about those parts of the dossiers in respect of which confidentiality has been requested as referred to in Article 7(3).

Textual Amendments