WA Sole Trader Manufacturing or Supplying Currently Unapproved Therapeutic Goods | AMA (WA)

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therapeutic goods

WA Sole Trader Manufacturing or Supplying Currently Unapproved Therapeutic Goods

Tuesday September 12, 2023

It is proposed that the Therapeutic Goods Act 1989 (the Act) be adopted to apply within WA. This will extend the Therapeutic Good Administration’s regulatory scope to include sole traders manufacturing or supplying therapeutic goods inside the State’s boundaries. A very small number of sole traders operating outside of the exemptions granted to medical practitioners may be impacted.

WA is the only jurisdiction in Australia yet to adopt the Act in this way. As the Act already applies to all incorporated entities across Australia, there will be no change to the status quo for any incorporated entity. Further, there is no anticipated cost impact for any entity already regulated under the Act. Adoption of the Act will, however, require sole traders in WA to meet the same rules as corporate entities and sole traders in other Australian jurisdictions.

Pharmacists, medical practitioners, dentists and hospitals are provided certain exemptions by the Act to allow manufacture of medicine or goods, under health practitioner supervision, based on individual patient’s unique medical needs. The changes could impact sole traders in WA who supply or manufacture currently unapproved therapeutic goods to others, as they will now need to meet established standards for therapeutic goods.

Health practitioners, Health Services Providers, and private hospitals already using products registered with the Therapeutic Goods Administration (TGA) and meeting established standards will not experience any changes.

If you believe the proposed changes may impact you, please provide feedback to the AMA (WA) by 19 September 2023 by emailing david.copland@amawa.com.au