Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Generic Health

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 27 October 2015, a delegate of the Secretary of the Department of Health, on the application of Generic Health, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of:

• PHARMACY ACTION LOW DOSE ASPIRIN – AUST R 190572- batch numbers 350293A and 350293B

that do not conform with the requirements of paragraphs 3(2)(g) and (l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines in that the medicine labels

• do not include the specific new warning statements applicable to this product contained in Schedule 2 to the Medicines Advisory Statements Specification 2014 which takes effect on 12 December 2015, and
• do not include the new street address of the sponsor.

The consent applies only to the above batches and is effective from the date of this letter until 30 June 2016.

The consent is subject to the following conditions:

1. The labels of the affected batches include the specific warning statement listed in Schedule 1 to the Medicines Advisory Statements Specification 2014.
2. The company has in place a redirection at Australia Post to ensure that any mail that is sent to the previous address (Level 1, 1175 Toorak Rd) is redirected to the new address (Level 1, 1102 Toorak Rd) until the expiry date of the affected batches.