COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 12 June 2015, 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”), on the application of Aspen Pharma Pty Ltd, gave consent to the supply of
- CHEMISTS’ OWN cold sore cream AUST R 106588,
- AMCAL cold sore cream AUST R 106590, and
- GUARDIAN cold sore cream AUST R 106586
that do not conform with the requirements of the section 8 of the Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines, in that the products do not comply with the acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis.
The consent is effective until 30 November 2016.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following condition:
- The products must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter <51> Antimicrobial Effectiveness Testing.