Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - between 14 August 2014 and 31 March 2015

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On August 14 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of                      Gilead Sciences Pty Ltd gave consent to the importation  and supply, of:

sofosbuvir (SOVALDI) 400 mg tablet bottle [AUST R 211019]  that does not conform with the requirements of  paragraph 3(2)(g) and 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that :

• the warning statement (signal heading) ‘Prescription only medicine, Keep out of reach of children’, required by clause 3(2)(g), is not in the approved form;
• the registered storage condition, ‘store below 30°C’, required by clause 3(2)(j), is absent.

The consent is effective from August 14, 2014 until March 31, 2015.

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. Further to the Company email assurance dated August 13, 2014 [TRIM reference R14/965623], users of the product under Gileads ‘compassionate access program’ will be informed to refer to the Australian consumer medicine information document, instead of the UK version supplied with the product to which this consent applies. For the very small number of private patients, this information will be communicated to their prescribing physician along with a copy of the Australian consumer information document; and
2. The labels to which this consent applies are those used for the UK market. They will be overstickered with the Australian sponsor’s address details and the AUST R number.