Embecta Australia Pty Ltd – Insulin syringe, fixed-needle (ARTG 486309) Needle, injector, medication/vaccine (ARTG 487048)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Embecta Australia Pty Ltd

I, Rowena Love, as a delegate of the Secretary to the Department of Health, Disability and Ageing, on receipt of an application from Embecta Australia Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertisements for the product identified in paragraph (B).

(A)

• The therapeutic goods are intended for:
  • People living with diabetes who require the administration of insulin.
  • People who require the administration of insulin as a part of their diabetes management. .

(B)

• Insulin syringe, fixed-needle (ARTG 486309)
• Needle, injector, medication/vaccine (ARTG 487048) .

Dated this 8^th day of July 25

Signed electronically

Rowena Love
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education Policy and Guidance Section
Regulatory Compliance Branch