Care Pharmaceuticals - FESS

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Care Pharmaceuticals Pty Ltd

I, Rowena Love, as a delegate of the Secretary to the Department of Health, on receipt of an application from Care Pharmaceuticals Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (A) below for use in consumer advertising of the products identified in paragraph (B):

(A)

• This FESS^® product is approved by the Sensitive Choice^® program, an initiative of the National Asthma Council Australia. Care Pharmaceuticals is a licenced partner and proud sponsor of the Sensitive Choice^® program.
• Approved by the National Asthma Council Australia Sensitive Choice^® program.
• The FESS^® range of products is approved by the National Asthma Council Australia Sensitive Choice^® program. Care Pharmaceuticals is an approved partner of the Sensitive Choice^® program.
• These FESS^® products are approved by the Sensitive Choice^® program, an initiative of the National Asthma Council Australia. Care Pharmaceuticals is a licenced partner and proud sponsor of the Sensitive Choice^® program.
• The blue butterfly means that the pictured [FESS product name that displays the blue butterfly product] has been assessed by the National Asthma Council Australia's independent and voluntary panel of experts and may be a suitable choice for people with medically diagnosed asthma or allergies.

(B)

• Products marketed as "FESS" under the following entries in the Australian Register of Therapeutic Goods:
• Care Pharmaceuticals Pty Ltd - Irrigation kit (ARTGs 156136, 297471 and 339184);
• Care Pharmaceuticals Pty Ltd - Irrigation kit, nasal (ARTGs 297500); and
• Care Pharmaceuticals Pty Ltd - Irrigation fluid, nasal (ARTGs 140816, 154889 and 297502).

Dated this 17th day of February 2021

Signed electronically

Rowena Love
Delegate of the Secretary to the Department of Health
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch