Consent given pursuant to Sections 14 and 14A for the supply of the therapeutic goods specified - between 3 November 2014 and 31 December 2015

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On November 3 2014, 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”), by application of Sandoz Pty Ltd gave consent to the supply of:

• epoetin lambda (rch)(NOVICRIT) 1,000 IU/0.5 mL solution for injection syringe

(AUST R 147847)

• epoetin lambda (rch)(NOVICRIT) 2,000 IU/1.0 mL solution for injection syringe

(AUST R 147833)

• epoetin lambda (rch)(NOVICRIT) 3,000 IU/0.3 mL solution for injection syringe

(AUST R 147849)

• epoetin lambda (rch)(NOVICRIT) 4,000 IU/0.4 mL solution for injection syringe

(AUST R 147843)

• epoetin lambda (rch)(NOVICRIT) 5,000 IU/0.5 mL solution for injection syringe

(AUST R 147859)

• epoetin lambda (rch)(NOVICRIT) 6,000 IU/0.6 mL solution for injection syringe

(AUST R 147844)

• epoetin lambda (rch)(NOVICRIT) 7,000 IU/0.7 mL solution for injection syringe

(AUST R 147835)

• epoetin lambda (rch)(NOVICRIT )8,000 IU/0.8 mL solution for injection syringe

(AUST R 147837)

• epoetin lambda (rch)(NOVICRIT )9,000 IU/0.9 mL solution for injection syringe

(AUST R 147838)

• epoetin lambda (rch)(NOVICRIT) 10,000 IU/1.0 mL solution for injection syringe

(AUST R 147842)

that does not conform with the requirements of paragraph 3(2)(l)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the packaging and labelling will contain the former sponsor’s (Novartis) name and phone contact details.

The consent is effective from November 3 2014 until December 31 2015.

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

1. An assurance that an application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the TGA for approval prior to supply in the first quarter of  2016.
2. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this consent, agreements and standard operating procedures (SOP) to cover the Products, to ensure that any adverse events, product complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable.