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

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 2 April 2015, 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”), on the application of Aspen Pharma Pty Ltd , gave consent to the importation and supply of

• ethambutol hydrochloride (MYAMBUTOL) 100 mg tablet bottle [AUST R 47887]

that does not conform with the requirements of paragraphs 3(2)(a) and 3(2)(j) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines, in that the labels do not include the proprietary name of the product and the approved product storage conditions.

The consent is effective from 2 April 2015 until 30 April 2017.

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

1. The bottle and carton labels to which this consent applies are those provided with the Company letter of application, viz the product labels currently in use in the United Kingdom.
2. The carton label must be over-labelled on the main label with a sticker stating the Australian sponsor’s name and address as well as the AUST R number of the product.
3. A ‘Dear Doctor’ and ‘Dear Pharmacist’ letter identical to that provided to the Therapeutic Goods Administration with the application dated 27 March 2015 and in the electronic mail dated 2 April 2015 respectively, advising them of the reason for the supply of UK-packaged stock in Australia, must be provided either as a general mail-out as relevant (Dear Doctor letter) or with each supply of the product (Dear Pharmacist letter).