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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, to the body specified in paragraph (3)—
(a)a final study report; and
(b)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 for reports falling under paragraph (3)(a), or by the Pharmacovigilance Risk Assessment Committee for reports falling under paragraph (3)(b).
(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).
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