(1) The Health Secretary may impose a new condition on a manufacturing licence.
(2) The Health Secretary may—
(a) amend or remove a condition the Secretary has imposed on a manufacturing licence under subsection (1) or section 30(1)(d); or
(b) amend the condition imposed on a manufacturing licence under section 30(1)(b) (including by amending the plan referred to in that provision).
(3) The Health Secretary may exercise a power under subsection (1) or (2)—
(a) on the application of the licensed manufacturer; or
(b) in the Secretary's discretion.
(4) An application under subsection (3)(a) must—
(a) be in writing; and
(b) be accompanied by the prescribed fee (if any); and
(c) include the prescribed information.
(5) The Secretary must determine an application under subsection (3)(a) within 28 days of receiving the application.
(6) If the Health Secretary refuses an application under subsection (3)(a), the Secretary must give the applicant reasons for the refusal.
(7) Within 7 days of exercising a power under subsection (1) or (2), the Health Secretary must give the licensed manufacturer a written notice specifying the amendment made.