COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 5 February 2014 a delegate of the Secretary of the Department of Health for the purposes of sections 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave consent to the following:
(a) the supply by CSL Ltd, 45 Poplar Road, Parkville, VIC 3052 (the Company) of Panvax Pandemic Influenza Vaccine (Split Virion, Inactivated, Adjuvanted) AUST R 137704.
AND
(b) the above goods not to conform with the requirements of Therapeutic Goods Order No. 77 Microbial Standards for Medicines Subsection 8 Efficacy of antimicrobial preservation of a medicine.
Pursuant to section 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This exemption from TGO 77applies to non-compliance of preservative efficacy testing for Staphylococcus aureus at 6 and 24 hours only. The product would therefore not be expected to undergo testing at 6 hours and would be expected to meet a requirement of “No Increase” at 24 hours for S. aureus only as per Eur.0153 Vaccines for Human Use and BP General Notice Vaccines.
- This exemption applies indefinitely.