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)

Suspension of an active substance registration in cases of urgency45S

1

The licensing authority may immediately suspend a person’s active substance registration for a period not exceeding three months where it appears to the licensing authority that in the interests of safety it is appropriate to do so.

2

This paragraph applies where—

a

a person’s active substance registration has been suspended under paragraph (1); and

b

it appears to the licensing authority that it is necessary to consider whether a person’s active substance registration should be—

i

further suspended or varied, or

ii

removed from the active substance register.

3

Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 45R (but this is subject to paragraph (4)).

4

Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 45R and any proceedings under that regulation have not been finally disposed of before the end of the period for which the registration was suspended under paragraph (1) or further suspended under paragraph (5).

5

If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the registration 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 45R to suspend, vary or remove a person’s active substance registration is made on an application to the High Court under regulation 322(4), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (validity of decisions and proceedings).