Consent given pursuant to sections 14 and 14A to the supply of the therapeutic goods specified by Baxter Healthcare

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 15 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 Baxter Healthcare Pty Ltd, gave consent to the supply of:

• octocog alfa (rch) ADVATE 250 IU powder for injection vial with diluent vial [AUST R 100384]
• octocog alfa (rch) ADVATE 500 IU powder for injection vial with diluent vial [AUST R 100385]
• octocog alfa (rch) ADVATE 1000 IU powder for injection vial with diluent vial [AUST R 100386]
• octocog alfa (rch) ADVATE 1500 IU powder for injection vial with diluent vial [AUST R 100387]
• octocog alfa (rch) ADVATE 2000 IU powder for injection vial with diluent vial [AUST R 136204]
• octocog alfa (rch) ADVATE 3000 IU powder for injection vial with diluent vial [AUST R 150366]
• octocog alfa (rch) ADVATE 4000 IU powder for injection vial with diluent vial [AUST R 214709]

that does not conform with the requirements of paragraphs (3)(2)(b)(c)(e)(g)(j)(k)(m)(n)) of the Therapeutic Goods Oder No 69 – General requirements for labels for medicine, in that due to unique design of the reconstitution device and the ready –to-activate configuration , minimal labelling of the vials (Advate and diluent) and Baxject III barrel has been proposed. The minimal labelling facilitates user inspection of vial contents by minimising the area obscured by label content.

The consent is effective from 15 June 2015 until there is a change to the configuration of Baxject III reconstitution system with potential impact on labelling.

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The sponsor commits to provide the training tools such as reconstitution device guideline booklets, troubleshooting reconstitution guides, videos and miniature LCD screen, unlimited supplies of samples of dummy devices and vials, Welcome kit (reference tool kit) for Health Care Professionals (HCPs) and patients that will minimise the risk of patients misusing the Baxject III reconstitution apparatus.
2. The sponsor provides assurance that processes/measures are available for implementation to ensure proper and safe use of Baxject III by HCPs and patients
3. The sponsor commits to Baxter’s product specialists and medical team will be trained to provide formal training on the use of the Baxtject III reconstitution apparatus, and will be able to assist any ad hoc questions that may occur.
4. The sponsor commits to include the approved Product Information and Consumer Medical Information (provided as a package insert) in Advate packaging.
5. This approval is applicable only to labels for products with Baxject III reconstitution system.