(1) A person who holds a Commonwealth licence to manufacture may apply to the Health Secretary for a manufacturing licence.
(2) An application must—
(a) be in writing; and
(b) be accompanied by the prescribed fee (if any); and
(c) specify the premises in relation to which the licence is sought; and
(d) specify whether the application is for—
(i) a manufacturing research licence; or
(ii) a general manufacturing licence; and
(e) identify each of the applicant's associates; and
(f) include a proposed plan for managing risks related to the conduct of activities authorised by a manufacturing licence; and
(g) identify the Commonwealth licence to manufacture that the person holds; and
(h) include the prescribed information (if any).