CHAPTER V

Transmission of reports of suspected adverse reactions

Individual case safety reports
Article 27
Individual case safety reports shall be used for reporting to the Eudravigilance database suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)