THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 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 salbutamol (VENTOLIN ROTACAPS) 200 mg insufflations strip pack [Aust R 12530] by GlaxoSmithKline Australia Pty Ltd, Melbourne, VIC (“the Company”);
That does not conform with the current British Pharmacopoeia (BP) monograph requirements for salbutamol powder for inhalation – Pre metered Units, in respect to deposition of the emitted dose.
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:
- The consent applies until January 01, 2014, when an updated BP monograph is expected to become official.
- No other changes have been made to the product, except for those approved within the submission (changes to the requirements for deposition of emitted dose, fine particle mass, by Cascade Impactor).
This grant of exemption is based upon the information and data provided with the application letter from the Company and with any subsequent correspondence relating to the application.