Australia Therapeutic Goods Act 1989 s41MQ-41MR: If an ARTG device application is withdrawn or lapses and the Secretary asks within 10 working days, say in writing within 20 working days whether you know of adverse event information and give it, accurately

What does s41MQ-41MR require?

When a device application is withdrawn or lapses, the Secretary has 10 working days in which to send the former applicant a written notice asking it to say in writing whether it is aware of any information of the section 41MP(2) or 41MPA(2) kinds about the device and, if so, to give it. Failing to comply within 20 working days of the notice, or giving false or misleading information in response, is an offence (12 months or 1,000 penalty units) and a civil penalty (up to 3,000 penalty units for individuals and 30,000 for bodies corporate).