COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 7 August 2013 the delegate of the Secretary of the Department of Health and Ageing 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 products – VAQTA hepatitis A vaccine inactivated 50 units/1 mL injection vial [AUST R 58536], VAQTA hepatitis A vaccine inactivated 25 units 0.5 mL injection vial [AUST R 58534] by Merck Sharp & Dohme Australia Pty Ltd, Macquarie Park, NSW (“the Company”);
That do not conform with paragraphs 3(2)(b) of Therapeutic Goods Order (TGO) 69, in that the active ingredient is not identified.
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 conditions:
- This exemption applies indefinitely
- The consent relates only to the specified part of the standard and all other parts must be complied with.