The Human Medicines Regulations 2012

3.—(1) Paragraph 2 does not apply to a proposal to refuse to grant or renew a UK marketing authorisation, certificate of registration or traditional herbal registration [F1 , or to a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,] if— U.K.

(a) the licensing authority has asked the applicant to supply information that the licensing authority thinks is relevant to enable the application to be determined [F2 or the decision to be made]; and

(b) the information has not been supplied to the authority within the relevant period.

(2) The relevant period is—

(a) where the licensing authority has completed its initial full assessment of the application, the period of six months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1); or

(b) where the licensing authority has completed its assessment of any supplemental information, the period of three months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1).

(3) The licensing authority may extend the relevant period if—

(a) the applicant asks it to do so;

(b) the applicant provides the grounds for that request; and

(c) the licensing authority thinks that the grounds are exceptional.

Textual Amendments

F1 Words in Sch. 11 para. 3(1) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2B)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

F2 Words in Sch. 11 para. 3(1)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2B)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))