THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On February 20, 2013 the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product primaquine (as phosphate)(PRIMACIN) 7.5 mg tablet tube [Aust R 63856], by Boucher & Muir Pty Ltd, North Sydney, NSW (“the Company”);
That do not conform with paragraphs 6(1)(a) and 9 of Therapeutic Goods Order (TGO) 80 ( Child Resistant Packaging requirements for Medicines), in that it will be supplied in packaging that is not child resistant.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent to supply applies until the end of 2013.
2. The product container is as currently used.
3. No other changes have been made to the product primaquine (as phosphate)(PRIMACIN) 7.5 mg tablet tube [Aust R 63856].
4. The Dear Healthcare Professional letter provided with the email correspondence of February 20 2013 from the Company will be supplied with the product, and all patients receiving the product will be given a copy of the patient handout supplied with the email of February 19 2013 from the Company.