Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41FK

                   An application that has been selected for auditing lapses if:

                     (a)  the applicant does not deliver to the office to which the application was made such information (in a form approved in writing by the Secretary) as will allow the audit of the application; or

                     (b)  the applicant does not comply with a requirement by the Secretary to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates; or

                     (c)  the applicant fails to comply with a notice under section 41JA to give information relating to devices of that kind to the Secretary within a further 10 working days from the day specified in the notice; or

                     (d)  information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a requirement under section 41JA, is false or misleading in a material particular; or

                     (e)  the applicant fails to pay an assessment fee for the application within the period, specified in the regulations, after being notified of the decision to include the kind of medical device in the Register under section 41FJ.