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 3Brokering

Annotations:
Amendments (Textual)

Procedure for determining an application for broker’s registration45C

1

The licensing authority must grant or refuse an application for registration under regulation 45B within the period of 90 days beginning immediately after the day on which it receives the application.

2

Paragraph (1) applies to an application only if the requirements of regulation 45B(2) have been met.

3

Before determining an application for a brokering registration, the licensing authority may notify the applicant of a requirement to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

4

If a notice under paragraph (3) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (1).

5

In paragraph (4), the “information period” means the period—

a

beginning with the day on which the notice is given, and

b

ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.