(1) As soon as practicable after the end of a reporting year, a sponsor shall, in relation to each investigational medicinal product or investigational medical device tested in clinical trials for which he or she is the sponsor furnish the Ethics Committee or National Competent Authority with —
(a) a list of all the suspected serious adverse reactions which have occurred during that year in relation to such clinical trials, including those reactions relating to any investigational medicinal product or investigational medical device used as a placebo or as a reference in the clinical trials; and
(b) a report on the safety of the subjects of the clinical trials.
(2) In subsection (1), “reporting year”, in relation to an investigational medicinal product or investigational medical device, means the year ending on the anniversary of —
(a) in the case of a product which has a marketing approval, the earliest date on which any such authorization relating to the product or device was granted or issued; or
(b) in any other case, the earliest date on which any clinical trial —
(i) relating to the product or device, and
(ii) for which the person responsible for making the report was the sponsor.