COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 18 November 2015, a delegate of the Secretary of the Department of Health, on the application of Ego Pharmaceuticals Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- PINETARSOL GEL tar 16mg/g tube – AUST R 49249
that does not conform with the requirements of the section 8 of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines in that the product does not meet the preservative efficacy requirements for A. niger specified in the British Pharmacopoeia, Appendix XVI C. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3).
The consent is effective from 18 November 2015 until 18 November 2017.
The consent is subject to the following condition:
- The efficacy of antimicrobial preservation of the medicine against A. niger must meet the requirement specified in the United States Pharmacopoeia - National Formulary Chapter <51> Antimicrobial Effectiveness Testing.