Consent given pursuant to Sections 14 and 14A for the importation and supply of the therapeutic goods specified by Pfizer Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 20 March 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 Pfizer Australia Pty Ltd , gave consent to the importation and supply of

• methotrexate (METHOBLASTIN) 2.5 mg tablet bottle [AUST R 15418]
• methotrexate (METHOBLASTIN) 10 mg tablet bottle [AUST R 15417]
• cabergoline (CABASER) 1 mg tablet bottle [AUST R 57360]
• cabergoline (CABASER) 2 mg tablet bottle [AUST R 57367]
• cabergoline (DOSTINEX) 0.5 mg tablet bottle [AUST R 52158]

that do not conform with the requirements of the provisions of Therapeutic Goods Order No. 80, Child-Resistant Packaging Requirements for Medicines , in that the products are not packed with child-resistant closures or child-resistant packaging.

The consent is effective from 20 March 2015 until 30 September 2015.

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

1. Each unit of the products to be supplied is provided with a companion item (33mm Cospak polypropylene child-resistance cap for Methoblastin tablets and white 20mL HDPE bottle with 28mm Clic-Loc polypropylene/HDPE child-resistant cap for Cabaser/Dostinex tablets) and instructions on how to carry out the corrective action, as stipulated in point 5 of the letter dated 19 March 2015.
2. Dear Pharmacist’ letters, one for Methoblastin and one for Cabaser and Dostinex, identical to those provided to the Therapeutic Goods Administration in the letter dated 19 March 2015 (point 7 and Attachments 13 and 14), are distributed to dispensing pharmacists advising them to take the necessary corrective action prior to dispensing the products to ensure that the container dispensed is child-resistant.
3. For Cabaser and Dostinex tablets, the dispensing label to be used on the replacement bottle/closure will include the details stated in point 6 of the letter dated19 March 2015.