PART 3F1Manufacture and distribution of medicinal products and active substances

Annotations:
Amendments (Textual)
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

F2CHAPTER 4Importation, manufacture and distribution of active substances

Annotations:
Amendments (Textual)

Power to suspend or vary or remove an active substance registration45Q

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).