Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Puremedic Pty Ltd
I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Puremedic Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a)(i) – (iv) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraphs (c) and (d) are met:
- i. May help to relieve or reduce breast pain and discomfort associated with mastitis;
ii. May reduce the recurrence of mastitis. Use at the first signs of mastitis;
iii. Mastitis relief – during breastfeeding; and
iv. May be used in conjunction with conventional treatment– under direction of your health care professional.
- Qiara Pregnancy & Breastfeeding (ARTG No. 269433)
- The use of the restricted representations on a label for the Medicine must be accompanied by a warning, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, which advises consumers to seek medical advice if symptoms persist; and
- The use of the representation ‘mastitis relief – during breastfeeding’ must only be used in conjunction with the representation that the Medicine may help to relieve or reduce breast pain and discomfort.
Dated this 9th day of June 2016
Delegate of the Secretary to the Department of Health; and
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch