# The Human Medicines Regulations 2012, Regulation 187: Recording obligations on holders


(1) Subject to paragraph (2), the holder must record all suspected adverse reactions to the product (including listed NIMAR products in Northern Ireland) occurring in the United Kingdom or another country 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 United Kingdom.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/187 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-187
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.