Consent given pursuant to Sections 14 and 14A for the supply and importation of the therapeutic goods specified - Galderma Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On October 23 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of Galderma Australia Pty Ltd, gave consent to the importation  and supply of:

brimonidine (MIRVASO) 3.3 mg/g (as tartrate) gel tube [AUST R 212325]  that does not conform with the requirements of paragraph 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that an unapproved storage temperature is stated.

The consent is effective from October 23, 2014 until batch 4516015 is exhausted.  

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The distribution of the affected batch will be recorded by the company and any remaining stock retrieved after 6 months.
2. The labels to which this consent applies are those provided to the Company by letter of application, they are the same as those approved except that the stated storage temperature is ‘below 30 °C’ instead of ‘below 25 °C’.
3. No other changes have been made to the product.