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4.—(1) A Strategic Health Authority must not publish or send to the bodies listed in regulation 2(2) any written documentation prepared for the purposes of a consultation under these Regulations unless the consultation has been approved by the Secretary of State.
(2) Within the period of 14 days beginning on the date on which a consultation required by these Regulations ends, or such longer period as the Secretary of State may determine, the Strategic Health Authority which has carried out the consultation must—
(a)send to the Secretary of State such documents or information as the Secretary of State may require; and
(b)report the results of the consultation to the Secretary of State and, if the Secretary of State so requires, provide copies of any written responses to the consultation.
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