The Human Medicines Regulations 2012 No. 1916

PART 11 U.K. Pharmacovigilance

Recording, reporting and assessment of pharmacovigilance data U.K.

Recording obligations on the licensing authority U.K.

185.  The licensing authority must record all suspected adverse reactions to medicinal products that—

(a) occur in the United Kingdom; and

(b) are reported to it by a patient or a patient's carer, a health care professional, a coroner or a procurator fiscal.