Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 19

Requirements for licence holders

    For the purposes of section   40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:

  (a)   if the Secretary so requests--details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and

  (b)   the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:

  (i)   the production of the goods; and

  (ii)   the quality control measures that are to be employed in the manufacture of the goods.



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