Carrying out a step in manufacturing therapeutic goods for human use at Australian premises without a licence that authorises that step at those premises (unless the goods are exempt goods or the person is an exempt person) is an offence tiered by harm and a civil penalty (sections 35 and 35A). Licences are granted only where the applicant can comply with the manufacturing principles (the ministerial principles, which adopt codes of good manufacturing practice) and the sites are satisfactory, and a licence can be refused for relevant convictions or penalties of the applicant, its managers or major interest holders within 10 years. Every licence carries conditions that the holder will ensure the goods meet applicable standards and observe the manufacturing principles, give the Secretary in writing information indicating unintended harmful effects, reduced effectiveness or unacceptable quality, safety or efficacy as soon as it becomes aware of it, provide information the Secretary requires, allow authorised persons to enter and inspect sites, goods and processes, test and sample, record images and question staff, and produce manufacturing documents and retained batch samples.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.