COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 23 November 2015, a delegate of the Secretary of the Department of Health, on the application of Sanofi Aventis Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- HEXAXIM Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) (DTPa-hepB-IPV-Hib) [AUST R 215536]
that do not conform with the requirements of the Therapeutic Goods Order No 69 General requirements for labels for medicines in that the syringe label does not comply with:
• Subparagraph 3(1)(b)(ii) in letter height of not less than 1.5 millimetres
• Paragraph 3(2)(c) the quantity or proportion of all active ingredients in the goods in accordance with clause 4
and the carton label does not comply with:
• Subparagraph 3(5)(b)(i) the name and quantity of each excipient in the goods because the syringes are labelled with the Standard International syringe label for Hexaxim and space limitations on the approved Australian carton label preclude complete compliance with Subparagraph 3(5)(b)(i).
The consent is effective from 23 November 2015 until 28 February 2017.
I consent under those sections to the importation and supply in Australia of 300 doses of batch L0119-2 with expiry 28 February 2017.
The consent is subject to the following conditions:
- A ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration on 27 October 2015 will be supplied.
- The product will be supplied with labels identical to those supplied to the Therapeutic Goods Administration with the application dated 27 October 2015.
- The consent only applies to 300 doses of batch L0119-2 with expiry 28 February 2017 of the product.