PART 11U.K.Pharmacovigilance

Post-authorisation safety studiesU.K.

Amendment to study protocols for required studiesU.K.

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

(2) The holder for the product which is the subject of the study must submit any substantial amendments to the study protocol [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),

before their implementation.]

(3) The body specified in this paragraph is—

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

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

(4) Paragraph (5) applies where a proposed amendment to a study protocol is submitted [F2only] to the licensing authority under paragraphs (2) and (3)(a) [F3(and is not submitted to the Pharmacovigilance Risk Assessment Committee)].

(5) Where this paragraph applies, the licensing authority must as soon as is reasonably practicable—

(a)assess the amendment; and

(b)inform the holder of its endorsement of, or objection to, the proposed amendment.

(6) Paragraph (7) applies where the proposed amendment to a study protocol is submitted to the Pharmacovigilance Risk Assessment Committee under paragraphs (2) and (3)(b).

(7) Where this paragraph applies, the holder who submitted the amendment must inform the competent authorities of the EEA States in which the study is being conducted of any amendment to the study protocol approved by the Pharmacovigilance Risk Assessment Committee as soon as is reasonably practicable.

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

Textual Amendments

F1Reg. 200(2)(a)(b) substituted for words in reg. 200(2) (31.12.2020) by S.I. 2019/775, reg. 160(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 128(a))