COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On October 9, 2013, 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”) gave his consent to:
(a) the supply of the product imiquimod (ALDARA) 50 mg/g cream pump [Aust R 191815],
by iNova Pharmaceuticals Pty Ltd, CHATSWOOD, NSW;
That does not conform with the British Pharmacopoeia/ European Pharmacopoeia (BP)/(EP) preservative efficacy testing requirements of the Therapeutic Goods Order (TGO) 77 with regard to A. brasiliensis.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following condition:
- The product complies with all other applicable requirements of Therapeutic Goods Order 77 ‘Microbiological Standards for Medicines’.