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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 />

12

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