Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 13 Submission and acceptance of applications

1. Applicants wishing to seek renewal of the approval of an active substance for one or more product-types shall submit an application to the Agency at least 550 days before the expiry of the approval. Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.

2. When applying for the renewal of the approval of the active substance, the applicant shall submit:

(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and

(b) its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.

3. The applicant shall also submit the name of the competent authority of the Member State that it proposes should evaluate the application for renewal and provide written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.

The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.

Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of the acceptance.

4. An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 3 of this Article.