COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 1 July 2015, a delegate of the Secretary of the Department of Health, on the application of AbbVie Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- VIEKIRA PAK RBV composite therapy packs [AUST R 224636, 224637, 224638, 234434 and 234442]
that do not conform with the requirements of the paragraphs 3(2)(a), 3(2)(l) & 3(5)(b) (j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicine, in that the product name differs from that agreed, and which appears on the carton labels, the sponsor's address (and website and phone number) are not those of the Australian sponsor and the storage condition is not described as permitted by clause 7 of Therapeutic Goods 0rder 69 and that the storage conditions differs from that assigned to the products.
The consent is effective from 1 July 2015 until 31 December 2015 (for a period of 6 months).
The consent is subject to the following conditions:
- The 'daily wallet' labels to which this consent applies are those provided with
the responses to S31-PM-2014-01438-I-2 (date March 2015).
2. A 'Dear Healthcare Provider/Pharmacist' letter identical to that provided to the Therapeutic Goods Administration on 30 June 2015 will be supplied only to Healthcare providers that have patients enrolled in sponsor's VIEKIRA PAK supply program.
3. No other changes have been made.