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11.—(1) A user must not undertake a contained use involving micro-organisms classified as class 3 or class 4 unless written consent for that contained use has been granted by the competent authority.
(2) A person responsible for the contained use must submit a notification to the competent authority containing the information specified in Schedule 6.
(3) The Executive must send an acknowledgement of receipt to the notifier within 10 working days of the competent authority receiving the notification.
(4) Where the premises in the notification have not previously been notified for class 3 or class 4 contained use, the competent authority must inform the notifier, in writing, of its decision to grant or refuse consent for the class 3 or class 4 contained use, within 90 days of the date on which the acknowledgement of receipt was sent to the notifier.
(5) Where the premises in the notification have previously been notified for class 3 or class 4 contained use and all relevant conditions of existing consents have been complied with, the competent authority must inform the notifier, in writing, of its decision to grant or refuse consent for the class 3 or class 4 contained use, within 45 days of the date on which the acknowledgement of receipt was sent to the notifier.
(6) Before granting consent, the competent authority must ensure that an emergency plan has been prepared where the risk assessment shows an emergency plan is required.
(7) Before deciding whether to grant or refuse consent, the competent authority must take into account any representations made to it by any person within 30 days of the date on which the acknowledgement of receipt was sent to the notifier.
(8) A consent granted under this regulation may be granted subject to conditions.
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