COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 5 June 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 Johnson & Johnson Pacific Pty Limited, gave consent to the supply of:
- SUDAFED PE SINUS & ANTI-INFLAMMATORY PAIN RELIEF tablet blister pack- AUST R 164735
that will not conform with the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the label does not display the warning statements to ask your doctor before use ‘with medicines that you are taking regularly’ or ‘if you are taking antidepressants’, which will be required by Schedule 2 of the Medicines Advisory Statements Specification 2014, which is due to come into effect on 12 December 2015.
The consent applies to batches 5CV0511 and 5CV0531 (in 20-tablet packs only) and batch 5CV0411 (in 48-tablet packs only), but only until 15 April 2016.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following condition:
- The labels to which this consent applies are those provided by Johnson & Johnson Pacific Pty Ltd on 4 June 2015.