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Regulation 256J Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the listF1F2

(1)

This regulation applies where—

(a)

the provisions of regulation 256K do not apply; and

(b)

the licensing authority proposes to exercise the power in regulation 256I.

(2)

The licensing authority must notify the person on the list in writing of—

(a)

its proposal;

(b)

the reasons for it; and

(c)

a specified date on which it is proposed that the suspension, variation or revocation should take effect.

(3)

The specified date in paragraph (2)(c) must be no earlier than 28 days following the date of the notice given by the licensing authority.

(4)

The person to whom notice is given under paragraph (2) may before the date specified in the notice—

(a)

make written representations to the licensing authority with respect to the proposal; or

(b)

notify the licensing authority that the person wishes that competent authority to submit the proposal to review upon oral representations.

(5)

If person on the list makes written representations in accordance with sub-paragraph (4)(a) the licensing authority must take those representations into account before making a decision in the matter.

(6)

If the person on the list gives notice of the proposal to review upon oral representation in accordance with paragraph (4)(b)—

(a)

Schedule 5 has effect; F3...

(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7)

If the licensing authority proceeds to suspend, vary or remove a person’s entry on the list in accordance with the provisions of regulation 256I it must give a notice to that person.

(8)

The notice must—

(a)

give particulars of the suspension, variation or removal; and

(b)

give reasons for the decision to suspend, vary or remove the person’s entry on the list.

(9)

Paragraphs (7) and (8) are without prejudice to any requirement of Schedule 5 as to notification.

Annotations

Textual amendments

F1

Pt. 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

F2

Words in regs. 256C-256M substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 197(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 151); 2020 c. 1, Sch. 5 para. 1(1)

F3

Reg. 256J(6)(b) and word omitted (31.12.2020) by S.I. 2019/775, regs. 1, 197(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)