THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On June 17 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
- hepatitis B surface antigen recombinant (H-B- VAX II HEPATITIS B VACCINE RECOMBINANT PRESERVATIVE-FREE PAEDIATRIC) 5 microgram/ 0.5 mL injection vial [Aust R 72347]
- hepatitis B surface antigen recombinant (H-B- VAX II HEPATITIS B VACCINE RECOMBINANT (Thiomersal free)) 40 microgram / 1mL injection vial [Aust R 90623]
- hepatitis B surface antigen recombinant (H-B- VAX II HEPATITIS B VACCINE RECOMBINANT-FREE PAEDIATRIC (Thiomersal free)) 10 microgram/1 mL injection vial [Aust R 90624]
by Merck Sharpe & Dohme, North Ryde, NSW (“the Company”);
That does not conform with paragraphs 3(2)(b) & 3(2)(c) of Therapeutic Goods Order (TGO) 69, in that the names of all active ingredients in the goods and the quantity or proportion of all active ingredients in the goods are not present on the labels.
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 consent is for the life of the current vial labels.
- No other changes have been made to the products;
- hepatitis B surface antigen recombinant (H-B- VAX II HEPATITIS B VACCINE RECOMBINANT PRESERVATIVE-FREE PAEDIATRIC) 5 microgram/ 0.5 mL injection vial [Aust R 72347]
- hepatitis B surface antigen recombinant (H-B- VAX II HEPATITIS B VACCINE RECOMBINANT (Thiomersal free)) 40 microgram / 1mL injection vial [Aust R 90623]
- hepatitis B surface antigen recombinant (H-B- VAX II HEPATITIS B VACCINE RECOMBINANT-FREE PAEDIATRIC (Thiomersal free)) 10 microgram/1 mL injection vial [Aust R 90624]