Embecta Australia Pty Ltd – needles and insulin syringes

Therapeutic Goods Act 1989

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

I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, 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 about the medical devices 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)

• Needle, injector, medication/vaccine (ARTG 430631)
• Needle, injector, medication/vaccine (ARTG 430632)
• Insulin syringe, fixed-needle (ARTG 430633)
• Insulin syringe, fixed-needle (ARTG 430634)

Dated this 4^th day of March 2024 

Signed electronically,

Michael Shum

Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch