The Human Medicines Regulations 2012

[F1Suspension of a person’s entry on the list in cases of urgencyU.K.

This adran has no associated Memorandwm Esboniadol

256K.(1) The competent authority of a member State may immediately suspend a person’s entry on the list for a period not exceeding three months where it appears to that competent authority that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a)a person’s entry on the list has been suspended under paragraph (1); and

(b)it appears to the competent authority of a member State that it is necessary to consider whether the person’s entry on the list should be—

(i)further suspended or varied, or

(ii)removed from the list.

(3) Where paragraph (2) applies, the competent authority of a member State must proceed as set out in regulation 256I (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the competent authority of a member State proceeds as set out in regulation 256I and any proceedings under that regulation have not been finally disposed of before the end of the period for which the person’s entry was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the competent authority of a member State to be necessary in the interests of safety to do so, the authority may further suspend the person’s entry on the list for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 256I to suspend, vary or remove a person’s entry on the list is made on an application under regulation 322(4) (validity of decisions and proceedings), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (interim order of the High Court).]

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