Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE
Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE
Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE
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Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
46 46(1) - On the basis of an assessment of the<br />
available informati<strong>on</strong> and the need <strong>to</strong> review<br />
the c<strong>on</strong>clusi<strong>on</strong>s of the initial evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> for Uni<strong>on</strong> authorisati<strong>on</strong> or, as<br />
appropriate the previous renewal, the<br />
evaluating competent authority shall within 30<br />
days […] decide whether, in the light of<br />
current scientific knowledge, a full evaluati<strong>on</strong><br />
of the applicati<strong>on</strong> for renewal is necessary.<br />
Service provided/ estimated cost<br />
range<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
renew a Uni<strong>on</strong> Authorisati<strong>on</strong>.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£10,120 (max) Sift, Technical Sift,<br />
Co-ordinati<strong>on</strong>, and 6 Specialist Data<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
3.6 days<br />
26 days<br />
Comments<br />
Covers <strong>HSE</strong>’s work in processing<br />
and evaluating the renewal<br />
applicati<strong>on</strong>. May be a full or<br />
shortened renewal depending<br />
whether there is substantial new<br />
evidence <strong>to</strong> take in<strong>to</strong> account – a<br />
decisi<strong>on</strong> <strong>on</strong> this will be taken by<br />
the Competent Authority.<br />
46(2) - Where the evaluating competent<br />
authority decides that a full evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> is necessary, the evaluati<strong>on</strong> shall<br />
be carried out in accordance with paragraphs<br />
1 and 2 of Article 44.<br />
Where the evaluating competent authority<br />
decides that a full evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> is not necessary, it shall, within<br />
180 days of the Agency accepting the<br />
applicati<strong>on</strong>, prepare and submit <strong>to</strong> the<br />
Agency a recommendati<strong>on</strong> <strong>on</strong> the renewal of<br />
the authorisati<strong>on</strong>. It shall provide the<br />
applicant with a copy of its recommendati<strong>on</strong>.<br />
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