Consent given pursuant to Sections 14 and 14A to import and supply of the therapeutic goods specified by Key Pharmaceuticals

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 26 August 2015, a delegate of the Secretary of the Department of Health, on the application of Key Pharmaceuticals, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to import and supply of:

• OsteVit D One-A-Week cholecalciferol 7000IU (175mcg) and AUST R 256292

that do not conform with the requirements of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO 78), in that it does not meet the stated content of the active ingredient is not within the range of ‘not less than 92.5 per cent and not more than 107.5 per cent’ of the stated content and the requirements for the test for disintegration of the as per the British Pharmacopoeia general monograph for “Capsules”.

The consent is effective from 26 August 2015 until further notice.

The consent is subject to the following conditions:

1. The product must comply with the acceptance criteria for the content of active ingredient as per the United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Cholecalciferol Capsules’
2. The product must comply with the requirements for test of disintegration as per the individual monograph for ‘Cholecalciferol Capsules’ in the USP-NF.