The Human Medicines Regulations 2012 No. 1916

PART 3 U.K. [F1 Manufacture and distribution of medicinal products and active substances]

Textual Amendments

F1 Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

[F2 CHAPTER 4 U.K. Importation, manufacture and distribution of active substances

Textual Amendments

F2 Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16

Power to suspend or vary or remove an active substance registration U.K.

45Q.— (1) The licensing authority may in accordance with regulation 45R—

(a) suspend an active substance registration for such period as the authority thinks fit;

(b) vary an active substance registration; or

(c) remove a person from the active substance register.

(2) The suspension of registration may be—

(a) total;

(b) limited to active substances of one or more descriptions; or

(c) limited to active substances imported, manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to an active substance registration except on one or more of the following grounds—

(a) the information in the application as a result of which the active substance registration was granted was false or incomplete in a material respect;

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

(c) the person with an active substance registration has materially contravened a criterion of registration; or

(d) the person with an active substance registration has without reasonable excuse failed to supply information to the licensing authority with respect to active substances of a description to which the registration relates when required to do so under regulation 45P(6).]