Certification of manufacturing steps outside Australia
32EB Certification of manufacturing steps outside Australia
The person in relation to whom a biological, other than a Class 1 biological, is included in the Register may apply to the Secretary for a certification under this section of a step in the manufacture of the biological that is to be carried out outside Australia.
If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable. The Secretary must give the person written notice of the certification.
In deciding whether to give the certification, subsections 25(2), (2E), (2F) and (2G) apply in a way corresponding to the way in which they apply for the purposes of paragraph 25(1)(g).
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