Regulation 200 Amendment to study protocols for required studies

This regulation applies where a study to which regulation 199 applies has been commenced.

The holder for the product which is the subject of the study must submit any substantial amendments to the study protocol F1to—

before their implementation.

The body specified in this paragraph is—

Paragraph (5) applies where a proposed amendment to a study protocol is submitted F5only to the licensing authority under paragraphs (2) and (3)(a) F6(and is not submitted to the Pharmacovigilance Risk Assessment Committee).

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

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).

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.

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