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

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 18 August 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 Boehringer Ingelheim Pty Limited, gave consent to the importation and supply of:

• DULCOLAX bisacodyl 5 mg tablet blister pack (AUST R 155405 )

that does not conform with the requirements of section 8 of the Therapeutic Goods Order No. 78 Standard for Tablets and Capsules, in that the products do not comply with the dissolution requirement of the British Pharmacopoeia monograph for Gastro-resistant Bisacodyl Tablets.

The consent is effective from 18 August 2015 until 1 June 2017.   

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

1. The product must comply with the approved in-house specification 0001891-115R-03 for tablet dissolution.
2. The product must comply with all other applicable parts of the British Pharmacopoeia monograph for Gastro-Resistant Bisacodyl Tablets, and all other applicable standards.