Paragraph 29 Duties on the holder of a marketing authorisation relating to an immunological product
Before the holder of a marketing authorisation for an immunological product places that product on the market he must either—
notify the Secretary of State and ask for his written approval to do so, or
if he 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.
If the Secretary of State is notified under sub-paragraph (1)(a) he must give or refuse a written approval as soon as is reasonably practicable.
It is an offence to 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.