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11.—(1) Subject to the following paragraphs of this regulation, no person shall undertake an activity involving genetic modification of micro-organisms in class 3 or class 4 unless he has—
(a)submitted to the competent authority a notification informing it of his intention to do so and containing the information specified in Part II of Schedule 6; and
(b)received the written consent of the competent authority to undertake the activity in question.
(2) Within 10 working days of the competent authority receiving a notification submitted in accordance with paragraph (1), the Executive shall send to the notifier an acknowledgement of receipt.
(3) Where a person proposes to undertake an activity referred to in paragraph (1) for the first time at the premises referred to in a notification submitted in accordance with that paragraph, the competent authority shall inform that person in writing of its decision to grant or refuse consent to undertake the activity in question not more than 90 days after the acknowledgement was sent in accordance with paragraph (2).
(4) Where a person proposes to undertake an activity referred to in paragraph (1) for the second or subsequent times at the premises referred to in a notification submitted in accordance with that paragraph, the competent authority shall inform that person in writing of its decision to grant or refuse consent to undertake the activity in question not more than 45 days after the acknowledgement was sent in accordance with paragraph (2).
(5) Before granting a consent under either paragraph (3) or paragraph (4), the competent authority shall ensure that any emergency plan has been prepared.
(6) Before deciding whether to grant or refuse a consent under either paragraph (3) or paragraph (4), the competent authority shall take into account any representations made to it by any person within 30 days of the date on which the Executive sent the acknowledgement of receipt in accordance with paragraph (2).
(7) A consent granted pursuant to this regulation may be granted subject to conditions.
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