Recording obligations on holders
187.—(1) Subject to paragraph (2), the holder must record all suspected adverse reactions to the product occurring in the EEA or in third countries which are brought to its attention irrespective of whether the reaction—
(a)is reported spontaneously by patients or health care professionals; or
(b)occurred in the context of a post-authorisation study.
(2) Paragraph (1) does not apply where the suspected adverse reaction occurred in the context of a clinical trial within the meaning of the Clinical Trials Regulations.
(3) The holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.
(4) The holder must ensure that reports recorded under paragraph (1) are accessible (electronically or physically) at a single point within the EEA.