For paragraph 3 (granting the authorisation) substitute—

“Procedure for grant of authorisations and time limits3.

(1)

The Secretary of State must process an application mentioned in paragraph 2 within 90 days of validating the application.

(2)

The Secretary of State must inspect the sites mentioned in paragraph 2(2)(b) within 90 days of validating the application.

(3)

The Secretary of State must grant the manufacturing authorisation if satisfied, following the inspection mentioned in sub-paragraph (2), that—

(a)

the sites are suitable for the intended purposes;

(b)

the applicant has—

(i)

suitable and sufficient staff, technical equipment and facilities for the proposed activities; and

(ii)

a documented quality management system in place.

(4)

Where the Secretary of State is not satisfied in relation to one or more of the matters mentioned in sub-paragraph (3), the Secretary of State may—

(a)

reject the application; or

(b)

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

(5)

The Secretary of State may extend the period for which a conditional manufacturing authorisation is granted under sub-paragraph (4)(b).

(6)

Where a conditional manufacturing authorisation is granted under sub-paragraph (4)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect without those conditions.”.