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 27 May 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, gave consent to the supply of:

• octocog alfa (rch) (RECOMBINATE) 250IU powder for injection vial and diluent vial

[AUST R 65814]

• octocog alfa (rch) (RECOMBINATE) 500IU powder for injection vial and diluent vial

[AUST R 65857]

• octocog alfa (rch) (RECOMBINATE) 1000IU powder for injection vial and diluent vial

[AUST R 65858]

that do not conform with the requirements of the paragraph (3)(2)(1)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines, in that Baxalta will be the sponsor of the above products from July 2015  but Baxter’s sponsor details and livery will appear throughout the labels for labelling grace period of 24 months. This grace period will be from 1 July 2015 to allow for the supply of relinquishing sponsor-labelled product (Baxter Healthcare Pty Ltd) under the accepting sponsor’s name (Baxalta Australia Pty Ltd).

The consent is effective from 27 May 2015 until 30 June 2017.

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

1. Change of sponsorship forms relevant to relinquishing (Baxter) and accepting (Baxalta) sponsors will be submitted to the Therapeutic Goods Administration before your global day 1 for separation which is 1st July 2015.
2. Transfer of sponsorship is taken to be the date that the legal agreement between the relinquishing and accepting sponsors takes effect.
3. An assurance that Baxter labelled stock will be used for 2 years and this ends on 30 June 2017.
4. There will be minimal or no disruption to ensure continuity of supply.
5. Baxalta labelled stock is required to be in the country 6 months before labelling grace period ends as advised in the submission dated 24 April 2015.
6. Processes/measures are being implemented for the proposed duration of the labelling grace period to ensure there are no gaps in communication of medical information to patients and safety reporting.
7. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd.