Recording obligations on the licensing authorityU.K.
This section has no associated Explanatory Memorandum
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 [F1a holder,] a patient or a patient's carer, a health care professional, a coroner or a procurator fiscal.
Textual Amendments
F1Words in reg. 185(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 144; 2020 c. 1, Sch. 5 para. 1(1)