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

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 25 August 2015, a delegate of the Secretary of the Department of Health, on the application of Clinect Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:

• naproxen (PROXEN SR 750) sustained release 750 mg tablets bottle [AUST R 47373]
• naproxen (PROXEN SR 1000) sustained release 1000 mg tablets bottle [AUST R 47442]

that do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the labels bear the former supplier and/or sponsor name, logo and contact details.

The consent is effective from 25 August 2015 until 31 March 2016.

The consent is subject to the following conditions:

1. The labels to which this consent applies are those previously approved for the former sponsor Roche Products Pty Ltd.
2. Arrangements are in place for all queries to be directed to Atnahs Pharma Australia Pty Ltd [the current sponsor];
3. The bottles will be recapped with child-resistant closures as proposed in the request dated 18 August 2015 (PM-2015-03007-1-3) and approved separately (TRIM ref: R15/667759).
4. No other changes have been made.