COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 26 November 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 paritaprevir/ritonavir/ombitasvir 75 mg/50 mg/12.5 mg tablets and dasabuvir (as sodium salt) 250 mg tablets composite pack blister pack [AUST R 224612]
that do not conform with the requirements of paragraphs 3(2)(a), (l) and (j) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the ‘daily wallet’ labels are the USA labels where:
- 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 TGO 69 and differs from that assigned to the product.
The consent is effective from 26 November 2015 until 31 July 2016.
The consent is subject to the following conditions:
- The 'daily wallet' labels to which this consent applies are those provided with the responses to the section 31 requests PM-2014-01436-1-2 & PM-2014-01438-1-2 (dated March 2015),
- A 'Dear Healthcare Provider /Pharmacist' letter identical to that provided to the TGA on 30 June 2015 will be supplied only to Healthcare Providers that have patients enrolled in sponsor's VIEKIRA PAK supply program, and
- No other changes have been made.