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

Article 31 Renewal of a national authorisation

1. An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the receiving competent authority at least 550 days before the expiry date of the authorisation. Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date.

2. The receiving competent authority shall renew the national authorisation, provided that the conditions set out in Article 19 are still satisfied. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

3. 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.

4. The receiving competent authority shall 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.

Upon receipt of the fees payable under Article 80(2), the receiving competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

5. 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 authorisation or, as appropriate, the previous renewal, the receiving competent authority shall, within 90 days of accepting an application in accordance with paragraph 4, decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

6. Where the receiving competent authority decides that a full evaluation of the application is necessary, it shall decide on the renewal of the authorisation after carrying out an evaluation of the application in accordance with paragraphs 1, 2 and 3 of Article 30.

Where the receiving competent authority decides that a full evaluation of the application is not necessary, it shall decide on the renewal of the authorisation within 180 days of accepting the application in accordance with paragraph 4 of this Article.

7. Where, for reasons beyond the control of the holder of a national authorisation, no decision is taken on the renewal of that authorisation before its expiry, the receiving competent authority shall grant a renewal for the period necessary to complete the evaluation.