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CELEX 02012R0528 · v20260819

Article 45 / Submission and acceptance of applications

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1.  
An application by or on behalf of an authorisation holder wishing to seek the renewal of a Union authorisation shall be submitted to the Agency at least 550 days before the expiry date of the authorisation.

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▼B

2.  

When applying for renewal, 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 authorisation or, as appropriate, previous renewal; and

(b) 

its assessment of whether the conclusions of the initial or previous assessment of the biocidal product 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 to it 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 to it under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of acceptance.

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