Validation of applications for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012
Article 5
1. Where an application for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012 containing the data required in accordance with Article 6(1) and (2) thereof has been accepted by the Agency pursuant to Article 4(2) and the fee has been paid pursuant to Article 4(4) the evaluating competent authority shall validate the application within 30 days of the payment of the fees. 2. Where the evaluating competent authority has received from the participant the dossier pursuant to Regulation (EC) No 1451/2007 but not yet accepted the dossier as complete pursuant to Article 13 thereof, the evaluating competent authority shall validate the application at the latest 3 January 2015. 3. In the cases referred to in paragraphs 1 and 2, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted. 4. Where the evaluating 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 evaluating 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 2. The evaluating competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant and the Agency accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) of Regulation (EU) No 528/2012 shall be reimbursed. On validating an application, the evaluating competent authority shall without delay inform the participant, the Agency and other competent authorities accordingly, indicating the date of the validation.