The Human Medicines Regulations 2012

2.—(1) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety, quality or efficacy— U.K.

(a) to refuse to grant or renew a UK marketing authorisation or traditional herbal registration in response to the application; or

(b) to revoke, vary or suspend a UK marketing authorisation or traditional herbal registration.

(2) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety or quality—

(a) to refuse to grant or renew a certificate of registration in response to the application; or

(b) to revoke, vary or suspend a certificate of registration.

[F1 (2A) The licensing authority must consult the appropriate committee if the authority proposes 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.]

(3) This paragraph is subject to paragraphs 3 and 4 (exceptions to requirement to consult).

(4) In this Schedule “the appropriate committee” in relation to any function means whichever of the bodies listed in paragraph (5) the licensing authority considers to be the appropriate body to perform that function.

(5) Those bodies are—

(a) the Commission; and

(b) any expert committee appointed by the licensing authority.

Textual Amendments

F1 Sch. 11 para. 2(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2A) (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))