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)

Variation of an active substance registration on an application from the registered person45T

1

This regulation applies if a person with an active substance registration applies to the licensing authority for a variation of the registration.

2

The application must—

a

be in writing;

b

specify the variation requested;

c

be signed by or on behalf of the applicant;

d

be accompanied by such information as may be required to enable the licensing authority to consider the application; and

e

include the appropriate fee in accordance with the Fees Regulations.

3

The licensing authority must vary an active substance registration or refuse to vary it within 30 days beginning with the day after the date when the licensing authority receives the application.

4

The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

5

If a notice under paragraph (4) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (3).

6

In paragraph (5), the “information period” means the period—

a

beginning with the day on which 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.

7

Nothing in this regulation affects the powers conferred by regulations 45Q and 45S.