PART 11U.K.Pharmacovigilance

Post-authorisation safety studiesU.K.

Submission and evaluation of final study reports for required studiesU.K.

201.—(1) This regulation applies where a study to which regulation 199 applies has been completed.

(2) Subject to paragraph (4), the holder for the product which is the subject of the study must submit electronically, before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended, [F1to—

(a)the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK);

(b)the licensing authority, where the authorisation for the product is a UKMA(GB),

a final study report and an abstract of the study results.]

(3) The body specified in this paragraph is—

(a)where the study was conducted in the United Kingdom only, the licensing authority; or

(b)in all other cases, the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (2) does not apply where a written waiver has been granted by the licensing authority F2..., or by the Pharmacovigilance Risk Assessment Committee F2....

(5) The holder must without delay—

(a)evaluate whether the results of a final study report submitted under paragraph (2) have an impact on the authorisation or registration of the medicinal product to which the report relates; and

(b)if necessary, submit an application to vary the authorisation or registration for the product.

(6) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

F1Reg. 201(2)(a)(b) substituted for words in reg. 201(2) (31.12.2020) by S.I. 2019/775, reg. 161(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 129(a))