Duties on the holder of a marketing authorisation relating to an immunological product
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.