COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 26 October 2015, a delegate of the Secretary of the Department of Health, on the application of GlaxoSmithKline Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- tretinoin 0.25 mg/g (STIEVA-A) 0.025% cream tube [AUST R 39837]
- tretinoin 0.5 mg/g (STIEVA-A) 0.05% cream tube [AUST R 39839]
that do not conform with the requirements of section 8 of the Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines, in that the product does not comply with the requirement for Aspergillus brasiliensis, according to the British Pharmacopoeia or the European Pharmacopoeia Efficacy of Antimicrobial Preservation test.
The consent is effective from the 26 October 2015 until further notice.
The consent is subject to the following conditions:
- The exemption is specifically for the requirements for A. brasiliensis and compliance against the other organisms specified will continue to apply.
- The exemption does not extend to compliance with the USP preservative efficacy test only.