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THERAPEUTIC GOODS ACT 1989 - SECT 32D Simplified outline of this Division

THERAPEUTIC GOODS ACT 1989 - SECT 32D

Simplified outline of this Division

A Class 1 biological can be included in the Register if a proper application is made and the applicant certifies various matters (see Subdivision B).

An export only biological can be included in the Register if a proper application is made, the applicant certifies various matters and, if steps in the manufacture of the biological have been carried out outside Australia, the Secretary has certified (where appropriate) that the manufacturing and quality control procedures used in those steps are acceptable (see Subdivision BA).

A biological, other than a Class 1 biological or an export only biological, can be included in the Register if a proper application is made and the Secretary is satisfied the biological is suitable for inclusion following an evaluation of the biological (see Subdivision C).



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