COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 16 January 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 Bayer Australia Ltd, gave consent to the importation and supply of:
ALKA-SELTZER LEMON-LIME FLAVOUR aspirin 324mg effervescent tablet strip (new formula) (AUST R 232907) that does not conform with the requirements of the section 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules, in that
- the limit for content of free salicylic acid at expiry (8.0%) exceeds the limit specified in the BP Monograph for Effervescent Soluble Aspirin Tablets (3.0%), and
- the limits for content of active ingredient at expiry (90.0-110.0%) are wider than the limit specified in the BP Monograph for Effervescent Soluble Aspirin Tablets (95.0-105.0%).
The consent is effective from 16 January 2015 until 2 December 2017.