The Human Medicines Regulations 2012

[F1 Procedure where the competent authority of a member State proposes to suspend, vary or remove a person’s entry on the list U.K.

256J.— (1) This regulation applies where—

(a) the provisions of regulation 256K do not apply; and

(b) the competent authority of a member State proposes to exercise the power in regulation 256I.

(2) The competent authority of a member State 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 competent authority of a member State.

(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 competent authority of a member State with respect to the proposal; or

(b) notify the competent authority of a member State 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 competent authority of a member State 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; and

(b) any reference to the licensing authority in Schedule 5 shall be read as a reference to the competent authority of a member State.

(7) If the competent authority of a member State 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.]

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