Regulation 185 Recording obligations on the licensing authority
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.
Annotations
Textual amendments
- F1
Words 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)