Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Abbvie Pty Ltd

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-RBV paritaprevir/ritonavir/ombitasvir 75 mg/50 mg/12.5 mg tabs & dasabuvir (Na) 250 mg tabs in blister & ribavirin 600 mg tabs bottle, composite pack [AUST R 234442].
• VIEKIRA PAK-RBV paritaprevir/ritonavir/ombitasvir 75 mg/50 mg/12.5mg tabs & dasabuvir (Na) 250 mg tabs and ribavirin 200 mg tabs, bottles composite pack [AUST R 224637].

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 container (‘daily wallet’) labels are the USA labels.

The consent is effective from 26 November 2015 until 31 July 2016.

The consent is subject to the following conditions:

1. 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),
2. 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
3. No other changes have been made.