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.
[ F1. . . . .]
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.
Textual Amendments
F1 Deleted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).
1.On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for Union authorisation or, as appropriate, the previous renewal, the evaluating competent authority shall, within 30 days of the Agency accepting the application in accordance with Article 45(3), decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary.
2.Where the evaluating competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1 and 2 of Article 44.
Where the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of the Agency accepting the application, prepare and submit to the Agency a recommendation on the renewal of the authorisation. It shall provide the applicant with a copy of its recommendation.
The evaluating competent authority shall, as soon as possible after the Agency has accepted the application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.
3.Within 180 days of receipt of a recommendation from the evaluating competent authority, the Agency shall prepare and submit to the Commission an opinion on the renewal of the Union authorisation.
4.On receipt of the opinion of the Agency, the Commission shall adopt either an implementing Regulation to renew the Union authorisation or an implementing decision to refuse to renew the Union authorisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
The Commission shall renew a Union authorisation, provided that the conditions set out in Article 19 are still satisfied.
5.Where, for reasons beyond the control of the holder of the Union authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Commission shall grant the renewal of the Union authorisation for the period necessary to complete the evaluation by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2).