Where an application for approval or inclusion in F4category B of the Simplified Active Substance List containing the data required in accordance with Article 6(1) and (2) of Regulation (EU) No 528/2012 has been accepted by the competent authority and the appropriate fee has been paid pursuant to Article 4 the competent authority shall validate the application within 30 days of that payment.

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In the cases referred to in F6paragraph 1, the F7... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the F8... competent authority considers that the application is incomplete, it shall inform the participant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F8... competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph F91.

The F8... competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant F10... accordingly. In such cases, part of the F11appropriate fees paid shall be reimbursed.

On validating an application, the F8... competent authority shall without delay inform the participant, F12... indicating the date of the validation.