Australia Therapeutic Goods Act 1989 s19B-21: Deal only in therapeutic goods that are registered or listed in relation to you, exempt, or covered by a section 19 or 19A approval, notify the Secretary of every manufacturer and manufacturing premises before dealing, and supply wholesale only goods that are registered, listed, exempt or approved

What does s19B-21 require?

Importing, exporting, manufacturing or supplying therapeutic goods for human use is an offence unless the goods are registered or listed goods in relation to that person, exempt goods, goods exempt under an emergency exemption (section 18A), or the subject of a special access, authorised prescriber or clinical trial approval or authority (section 19) or a shortage substitute approval (section 19A); penalties are tiered by harm with civil penalties under section 19D. A sponsor must also have properly notified the Secretary of each manufacturer and each manufacturing premises (nominated in the application or later notified in writing) before it imports, exports, manufactures or supplies the goods (section 20). A person who is not the sponsor must not supply goods to anyone other than the ultimate consumer unless they are registered, listed, exempt or approved (section 21, 120 penalty units).