The Human Medicines Regulations 2012

Exceptions to requirement to consult U.K.

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))

4.—(1) Paragraph 2 does not apply to a proposal to suspend a UK marketing authorisation, certificate of registration or traditional herbal registration if the licensing authority thinks that, in the interests of safety, it is necessary to suspend the authorisation, certificate or registration with immediate effect for not more than three months. U.K.

(2) In that event the licensing authority must report the suspension to the appropriate committee forthwith.

(3) Sub-paragraph (4) applies if, following a suspension to which this paragraph applies—

(a) the licensing authority thinks that the authorisation, certificate or registration should be further suspended, or varied or revoked; or

(b) the appropriate committee advises that the authorisation, certificate or registration should be further suspended, or varied or revoked.

(4) The provisions of this Part of this Schedule (including this paragraph) apply accordingly to the suspension, variation or revocation.