COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 20 February 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 Link Medical Products Pty Ltd T/A Link Pharmaceuticals, gave consent to the importation and supply of:
- hydralazine hydrochloride (APRESOLINE) 20 mg powder for injection ampoule [AUST R 43190]
that do not conform with the requirements of, paragraphs 3(2)(g), (j) and 3(11)(c ) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the labels do not state all relevant warnings, the Australian approved storage conditions and details of the Australian sponsor (ampoule only).
The consent is effective from the 20 February 2015 until batch number 140604 (expiry date 02/2019) is exhausted or is expired.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which the consent applies are those provided with the letter of application, where dextrose is stated instead of the Australian Approved Name (AAN) glucose.
- The cartons will be over-labelled with the AUST R number and the Australian sponsor’s details;
- A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA with the letter of application (dated 10 February 2015) will be supplied with each affected batch stating that the storage conditions and carton leaflet should be disregarded.
- A copy of the Australian approved Product Information document will accompany each ‘Dear Healthcare Provider’ letter;
- The Company’s assurance via electronic mail dated 20 February 2015 that the batch will comply with the Australian approved specifications; and
- No other changes have been made to the product.