COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 12 February 2013 , the delegate of the Secretary of the Department of Health and Ageing 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 Merck Sharp & Dohme Australia Pty Ltd, 66 Waterloo Road, North Ryde NSW 2113(the Company) of the following products:
- Aust R 118449 M-M-R II composite pack with diluent vial
- Aust R 118451 M-M-R II injection vial
- Aust R 201877 M-M-R II composite pack with diluent syringe AND
(b) for the above goods not to conform with the requirements of clauses 3(2)(b) and 3(2)(c) of the Therapeutic Goods Order No 69 - “General Requirements for Labels for Medicines”, in that the names an quantities of the active ingredient are not included on the vial labels.
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:
1. No other changes are made to the products:
- Aust R 118449 M-M-R II composite pack with diluent vial
- Aust R 118451 M-M-R II injection vial
- Aust R 201877 M-M-R II composite pack with diluent syringe.