Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE

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Article in 528/2012 Article Text 8(1) The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Articles 4 and 5, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3), and send an assessment report and the conclusions of its evaluating to the Agency. Service provided/ estimated cost range Evaluation of an application to approve an active substance under Article 8. £185,000 (min) Active substance (AS) Full Data Package plus Active substance EU Discussion £315,000 (max) Active substance Full Data Package plus 7 Extra data Packages and Active substance EU Discussion Daily rate/ estimated timescale range £447 414 days 705 days Comments Covers work in carrying out the substantive evaluation of an application for active substance approval. 6
Article in 528/2012 Article Text 14 14(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 approval or, as appropriate, the previous renewal, the evaluating competent authority shall, within 90 days of the Agency accepting an application in accordance with Article 13(3), decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary […] Service provided/ estimated cost range Evaluation of an application to renew an active substance approval under Article 14. £12,000 (min) Active substance renewal Initial Fee If a full evaluation is required then fees as 8(1) Daily rate/ estimated timescale range £447 27 days Comments Covers work on renewing an existing approval of an active substance. The quantity and timeframe will depend on whether the evaluating competent authority (HSE) decides that a full evaluation of the substance is necessary. Full evaluations are carried out under Article 8. 14(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, 2 and 3 of Article 8. 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 in accordance with Article 13(3), prepare and submit to the Agency a recommendation on the renewal of the approval of the active substance. It shall provide the applicant with a copy of its recommendation. 7
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Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE

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