The Human Medicines Regulations 2012 No. 1916

SCHEDULES

[F1 SCHEDULE 12A U.K. Further provision as to the performance of pharmacovigilance activities

Textual Amendments

F1 Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)

PART 9 U.K. Post-authorisation safety studies

Scope and interpretation U.K.

28.— (1) This Part applies to non-interventional post-authorisation safety studies initiated, managed or financed by a holder under obligations imposed under regulation 59 or 61 (conditions of UK marketing authorisation).

(2) In this Part—

“start of data collection” means the date on which information on the first study subject is first recorded in the study dataset or, in the case of the secondary use of data, the date on which the data extraction starts; and

“end of data collection” means the date on which the analytical dataset is completely available.]