COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 29 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 Pfizer Australia Pty Ltd, gave consent to the importation and supply of:
- cabergoline (CABASER) tablets 1 mg and 2 mg in bottles [AUST R 57360 & 57367]
- cabergoline (DOSTINEX) tablet 0.5 mg in 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 (TGO 80) in that the products are not packed with child-resistant packaging.
The consent is effective from 29 May 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:
- Each unit of the products to be supplied is provided with a companion item (white 20mL HDPE bottle with white 28mm PP child-resistant closure, C28S2L or C28S2R) and instructions on how to carry out the corrective action, as stipulated in point 5 of an earlier letter dated 19 March 2015 from your company in relation to the same matter.
- A ‘Dear Pharmacist’ letter, identical to that provided to the Therapeutic Goods Administration in the letter dated 19 March 2015 (point 7) is 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. The dispensing label to be used on the replacement bottle/closure will include the details stated in point 6 of the letter dated 19 March 2015.