The Human Medicines Regulations 2012

[F1Power to suspend, vary or remove a person’s entry on the listU.K.

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256I.(1) The competent authority of a member State may in accordance with regulation 256J—

(a)suspend a person’s entry on the list for such period as the authority thinks fit;

(b)vary a person’s entry on the list; or

(c)remove a person’s entry from the list.

(2) The suspension of person from the list may be—

(a)total;

(b)limited to medicinal products of one or more descriptions; or

(c)limited to medicinal products sold at a distance from specified premises or a specified part of any premises.

(3) The power conferred by this regulation may only be exercised on one or more of the following grounds—

(a)in relation to any information notified to the competent authority of a member State under regulation 256C as a result of which the person was included in the list—

(i)the information so supplied was false or incomplete in a material respect,

(ii)a material change of circumstances has occurred in relation to any of the matters stated in the notification;

(b)the person on the list has materially contravened a condition required to be met by a person entered on the list under regulation 256H; or

(c)the person on the list has without reasonable excuse failed to supply information to the competent authority of a member State with respect to their notification when required to do so under regulation 256F(3).]

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