COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On March 26, 2014, 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”) gave his consent to:
(a) the supply of the product ADRENALINE-LINK 1:10,000 1mg/10mL (as acid tartrate) injection BP pre filled syringe [Aust R 210672] by Link Medical Products Pty Ltd, WARRIEWOOD, NSW;
That does not conform to the Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), in that:
- The warning statements (clause 3(5)(b)(ii) relating to single use in one patient on one occasion only) are not as specified in the Order;
- Excipient quantities (clause 3(5)(b)(i)) are not included;
- A statement of the purpose or purposes for which the goods are intended is missing (clause 3(2)(m));
- The syringe labels do not include the name or registered trade mark of the sponsor or supplier or the proprietary name (clause 3(11)(c)).
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 to supply applies from the date of this letter until the end of April 2014.
- The product to which this consent applies is identical in all respects to the currently approved product, and is the UK-labelled product which has been previously supplied in Australia under section 19A of the Act.
- The Dear Healthcare Provider letter supplied with the Company letter of application [TGA ref: R14/381304] explaining the circumstances behind this consent and providing information on differences between the approved Australian product information and the UK product information to be supplied with affected stock, will be supplied with the product.