COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 28 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 Merck Sharp & Dohme, gave consent to the importation and supply of:
- ONCOTICE BCG 5 hundred million CFU powder for injection vial [AUST R 59912]
that does not conform with the requirements of the subclauses 3(2)(c), 3(2)(l), 3(2)(n) and 3(5)(b) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the contents on the carton and vial labels are stated as 2-8 x 108 CFU Tice BCG instead of 5 x 108 CFU Tice BCG, the name and address of the Australian Sponsor is not stated on the carton label, AUST R number is not listed on the carton label and the list of excipients is not listed on the carton label.
The consent is effective from the date of this letter until 16 February 2016 and applies to 400 units (Batch Number 746307) of the Product.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 23 April 2015 be supplied with each affected batch instructing that the dosage instructions in the enclosed leaflet should be ignored and that the Australian PI accompanying the letter should be referred for dosage instructions, as the dosages differ across the two countries.
2. Direct the user to the PI available on the TGA website at www.tga.gov.au