28.—(1) A marketing authorisation holder must immediately inform the Secretary of State if he receives any new information that might adversely affect the risk-benefit balance of the veterinary medicinal product.
(2) He must immediately inform the Secretary of State of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is authorised.
(3) The Secretary of State may at any time require the marketing authorisation holder to provide data relating to the risk-benefit balance.
(4) It is an offence to fail to comply with this paragraph or a requirement under it.