COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 15 October 2013, the 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 his consent to the following:
(a) the supply by Novartis Vaccines & Diagnostic Pty Ltd, 54Waterloo Road, North Ryde NSW 2113 (the Company) of MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine Aust R 192696 AND
(b) for the vial labels of the above goods not to conform with the requirements of Therapeutic Goods Order No 69 - “General Requirements for Labels for Medicines”.
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:
- No other changes are made
- This exemption applies only to Batch No. M12045 of Austrian origin with Austrian vial labels in German language
- Each vial of the product is to be repacked into Australian approved outer packaging (carton) with the Australian product information (PI) and provided together with the “Dear Doctor” letter which was submitted to the TGA on 11 October 2013.
- Normal TGA Lot Release processes will apply to this repackaged batch.