The Human Medicines Regulations 2012

[F1Grant or refusal to list a personU.K.

This section has no associated Explanatory Memorandum

256G.—(1) On receipt of a notification from a person to be included in the list—

(a)the [F2licensing authority] must include that person on the list if that person complies with the requirements in regulation 256C(2) to (5); or

(b)if it considers necessary or appropriate to do so, the [F2licensing authority] must refuse to include that person on the list having had regard to—

(i)the provisions of these Regulations, and

(ii)any EU obligation.

(2) The [F2licensing authority] must give a notice stating the reasons for its decision in any case where [F3the licensing authority]—

(a)refuses to include a person on the list; or

(b)includes a person in the list otherwise than in accordance with the notification and that person requests a statement of its reasons.

(3) Where the [F2licensing authority] decides to include a person on the list [F4the licensing authority] must ensure that the [F5website of the licensing authority] includes—

(a)the name or corporate name of the person that is listed; and

(b)the person’s website address in the United Kingdom.]

Textual Amendments

F1Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28

F4Words in reg. 256G(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(7)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)

F5Words in reg. 256G(3) substituted (31.12.2020) S.I. 2019/775, regs. 1, 197(7)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)