9.—(1) The manufacturer or importer of a product must notify the Secretary of State of any serious adverse reactions (as defined in paragraph 56 of Schedule 1) of which he becomes aware within 15 days of learning of the reaction.
(2) It is an offence to fail to comply with this paragraph.
Commencement Information
I1Sch. 6 para. 9 in force at 1.10.2006, see reg. 1