COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 7 April 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:
MENINGITEC meningococcal serogroup C conjugate vaccine suspension for injection pre-filled syringe AUST R 134363 (the Product)) being imported into AND/OR supplied in Australia by Emerge Health Pty Ltd, Suite 3 Level 1, 2 Theatre Place, Canterbury VIC 3126 notwithstanding it does not fully conform with the requirements of clause 3(2)(l) of the Therapeutic Goods Order (TGO) 69 ‘General requirements for labels for medicines’ in that the details of the previous sponsor appear on the labels instead of those of the current sponsor (Emerge Health).
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 consent to supply applies until the end of September 2014.
- The labels to which this consent applies are as supplied with your application.
- Arrangements are in place for the prompt referral of all queries or complaints concerning the product to Emerge Health.
- The Dear Healthcare Provider letter supplied with your application will be supplied with every delivery of the product