THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On September 10 2012 the delegate of the Secretary of the Department of Health and Ageing 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 following products by AbbVie, Botany, NSW (“the Company”):
- paricalcitol (Zemplar Capsule) 2 micrograms capsule blister pack [Aust R 121762]
- ritonavir (Norvir) 100 mg tablets bottle [Aust R 158301]
- lopinavir 200 mg and ritonavir 50 mg (Kaletra Tablets) tablets bottle [Aust R 121055]
- lopinavir 100 mg and ritonavir 25 mg (Kaletra Tablets) tablets bottle [Aust R 140509]
- (Kaletra) oral solution bottle [Aust R 78627]
- Calcitriol (Calcijex) 1 microgram/1 mL injection ampoule [Aust R 54452]
That do not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the previous name of the sponsor (Abbot) is listed on the labels on the cartons and containers instead of the new sponsor name (AbbVie).
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 consent to supply applies for a period of two years from September 10 2012.
- The labels to be used are identical to those provided by the Company in correspondence dated September 6 2012.
- No other changes have been made to the products listed above.
- Details of the process in place to ensure continuous customer contact with the Company are as described in correspondence from the Company dated August 1 2012.