COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 11 August 2015, a delegate of the Secretary of the Department of Health, on the application of iNova Pharmaceuticals Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of;
- NYAL ANTIVIRAL COLD SORE CREAM - AUST R 147218
that does 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 acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis.
The consent is effective from 11 August 2015 until 30 November 2016.
The consent is subject to the following conditions:
- The product must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter <51> Antimicrobial Effectiveness Testing.
2. The product must meet all other requirements of the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation.