COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 7 July 2015, a delegate of the Secretary of the Department of Health, on the application of Merck Sharp & Dohme Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- fidaxomicin (DIFICID) 200 mg tablets in bottles [AUST R 195623]
that do not conform with the requirements of paragraph 3(2)(g), 3(2)(j) and 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the Canadian labelling is used on the bottle label such that the warning statements, Australian storage condition and name and address of the Australian sponsor or supplier of the product are absent.
The consent is effective from 7 July 2015 until the supply of the 300 units of the batch PYGX products is exhausted.
The consent is subject to the following conditions:
- The labels to which this consent applies are the Canadian labels that are provided with the letter to the Therapeutic Goods Administration (TGA) dated 20 May 2015 and including the over-stickers for warning statements, Australian storage condition and name and address of the Australian sponsor of the product and ARTG number as included in the letter to the TGA dated 1 July 2015;
- A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA on 1 July 2015 (TRIM reference R15/527051) will be supplied with the Canadian stock instructing Healthcare Professionals to ignore the Canadian labelling information on the bottle label and refer to the over-labelling on the carton.
- No other changes have been made.