COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 12 May 2014, 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 VAXIGRIP INFLUENZA VACCINE (split virion) 0.5 mL injection syringe [Aust R 80198], by Sanofi-Aventis Australia Pty Ltd , Macquarie Park NSW (“the Company”);
That does not conform with paragraphs 3(1)(b)(ii), 3(2)(l), 3(2)(n), 3(5)(b)(ii) of Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), in that
- the letter height is not as specified in the Order (3(1)(b)(ii))
- the sponsor name is not stated (3(2)(l))
- the registration number is not stated (3(2)(n))
- The warning statements (clause 3(5)(b)(ii) relating to single use in one patient on one occasion only) are not as specified in the Order
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:
- The labels for use are those submitted with your application, with an oversticker stating the AUSTR No and the Australian Sponsor name and address on the carton label
- Each carton is to be supplied with the Australian Specific Product Information (PI);
- That this exemption will comply to the following batches only:
-Vaxigrip 1s L7093-3, Expiry 31 January 2015, 89,361 doses
-Vaxigrip 1s L7093-4, Expiry 31 January 2015, 39,709 doses
-Vaxigrip 1s K0521-2, Expiry 30 November 2014, 20,930 doses