Regulation 84 New paragraph 4A

After paragraph 4 insert—

“Application for variation to the authorisation

4A.

(1)

The holder of a manufacturing authorisation must notify the Secretary of State, and apply for a variation of the authorisation, before—

(a)

making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used;

(b)

changing the qualified person (manufacture), the person with responsibility for quality control or the person with responsibility for production.

(2)

The Secretary of State must process an application under sub-paragraph (1) within 30 days of receiving it unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days.

(3)

The Secretary of State must grant the application under sub-paragraph (1) if satisfied in respect of the matters in paragraph 3(3) as regards the proposed variation.

(4)

The Secretary of State may inspect any site to which the manufacturing authorisation or proposed variation relates in connection with the application.

(5)

Where the Secretary of State is not satisfied for the purposes of sub-paragraph (3), the Secretary of State may—

(a)

reject the application; or

(b)

grant a conditional variation to the manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

(6)

The Secretary of State may extend the period for which a conditional variation to the marketing authorisation is granted under sub-paragraph (5)(b).

(7)

Where a conditional variation to the manufacturing authorisation is granted under sub-paragraph (5)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect as so varied without those conditions.”.