COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On October 29 2014, 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”), by application of bioCSL (Australia) Pty Ltd gave consent to the importation and supply of
lignocaine (VERSATIS) 5% w/w dermal patch [AUST R 175178] that does 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 it does not include the contact details of the current sponsor of the product.
The consent is effective from October 29 2014 until June 30 2017.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor, Grunenthal Australia Pty Ltd, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to bioCSL (Australia) Pty Ltd.