COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 2 April 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 Mallinckrodt Australia Pty Ltd , gave consent to the importation and supply of
- injection composite pack (ULTRATAG RBC ) [AUST R 47860]
that does not conform with the requirements of paragraph 3(2)(j) & 3(5)(b)(i) of the Therapeutic Goods Order No. 69- General requirements for labels for medicine, in that the storage condition is not described as permitted by clause 7 of TGO69 (component labels only) and that the name and quantity of each excipient in the product is not stated on the main label (outer carton only) in that the product is supplied with the US labelling.
The consent is effective from 2 April 2015 until the batch is exhausted.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those provided with the Company letter of application;
- The cartons will be over-labelled with the AUST R number, the Australian approved storage conditions, the name and quantity of the active ingredient, and the Australian sponsor’s details;
- A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration dated 31 March 2015 (TGA ref: R15/251344) will be supplied with each affected batch stating that the US carton leaflet should be disregarded, that the Australian approved storage conditions should continue to be applied, and that the formulation is unchanged;
- A copy of the Australian product leaflet will accompany each ‘Dear Healthcare Provider’ letter;
- No other changes have been made to the product.