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29.—(1) Before placing an immunological product on the market the holder of the marketing authorisation must either—
(a)notify the Secretary of State asking for written approval to do so; or
(b)if the holder has already received written approval from another member State permitting the release of the product, send a copy of that approval to the Secretary of State.
(2) If notified under sub-paragraph (1)(a) the Secretary of State must give or refuse a written approval as soon as is reasonably practicable.
(3) No person may place an immunological product on the market without a written approval issued by the Secretary of State or (if the approval was issued by another member State) without sending a copy of that approval to the Secretary of State.
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