40BVariation of licences—application by licence holder

40B Variation of licences—application by licence holder

Addition of manufacturing sites (1) If the holder of a licence is of the view that, having regard to the guidelines under section 38A, the licence could cover one or more additional manufacturing sites, the holder may apply to the Secretary for a variation of the licence so that it covers one or more additional manufacturing sites specified in the application. (2) An application under subsection (1) must: (a) be made in accordance with a form approved by the Secretary; and (b) identify the therapeutic goods or classes of therapeutic goods that the holder proposes to manufacture at each additional manufacturing site specified in the application; and (c) identify the steps in the manufacture of those goods that the holder proposes to carry out under the licence; and (d) if the holder proposes to carry out steps in the manufacture of blood or blood components under the licence—contain information relating to those steps set out in regulations made for the purposes of paragraph 37(1)(da); and (e) state the names, qualifications and experience of the persons who are to have control of the manufacture of the goods and of the quality control measures that are to be employed; and (f) be delivered to an office of the Department specified in the form; and (g) be accompanied by the prescribed application fee. (3) If an application is made under subsection (1) and any applicable prescribed inspection fees have been paid, the Secretary may, by notice in writing given to the holder of the licence, vary the licence so that the licence covers each additional manufacturing site specified in the notice. (4) For each manufacturing site specified under subsection (3), the Secretary must, in the notice under that subsection, vary the licence to authorise the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.

Note 1: For specification by class, see subsection 33(3AB) of the Acts Interpretation Act 1901.

Note 2: Section 40A and subsections (6) to (9) of this section deal with variation of authorisations.

(5) A variation under subsection (3) or (4) takes effect on the day on which the notice is given to the holder. Variation of manufacturing site authorisations (6) The holder of a licence may apply to the Secretary for a variation of a manufacturing site authorisation in relation to the licence. (7) An application under subsection (6) must: (a) be made in accordance with a form approved by the Secretary; and (b) set out the variation sought; and (c) be delivered to an office of the Department specified in the form; and (d) be accompanied by the prescribed application fee. (8) If an application is made under subsection (6) and any applicable prescribed inspection fees have been paid, the Secretary may, by notice in writing given to the holder of the licence, vary the manufacturing site authorisation. (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder. Removal of manufacturing sites (9A) The holder of a licence may apply to the Secretary for a variation of the licence so that it ceases to cover one or more manufacturing sites specified in the application. (9B) An application under subsection (9A) must: (a) be made in accordance with a form approved by the Secretary; and (b) be delivered to an office of the Department specified in the form; and (c) be accompanied by the prescribed application fee. (9C) If an application is made under subsection (9A), the Secretary may, by notice in writing given to the holder of the licence, vary the licence so that the licence does not cover each manufacturing site specified in the notice. (9D) A variation under subsection (9C) takes effect on the day specified in the notice. Further information (10) The Secretary may, by notice in writing given to the holder of a licence who has made an application under subsection (1), (6) or (9A), require the holder: (a) to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice; or (b) for an application under subsection (1) or (6)—to allow an authorised person, at any reasonable time specified in the notice, to inspect each manufacturing site identified in the application and the equipment, processes and facilities that will be used in the manufacture of therapeutic goods at that site. Applications or information may be given electronically (11) An approval of a form mentioned in paragraph (2)(a), (7)(a) or (9B)(a), or a notice mentioned in subsection (10), may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission.