COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On October 21, 2013 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 , tiludronate disodium (SKELID)(equiv tiludronic acid 200 mg) tablets blister pack [Aust R 54569], by Sanofi-Aventis Australia Pty Ltd NORTH RYDE, NSW (“the Company”);
That do not conform with paragraphs 3(1),3(2)(h) and 3(2)(i) of Therapeutic Goods Order (TGO) 69, in that the information on the foil labels is written in French, contrary to clause 3(1) requiring that the particulars should be written in English. The prefixes for batch number and expiry date are missing from the foils labels.
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 applies to batch 2A001 of the product, comprising approximately 600 units.
2. The foil labels to which this consent applies are those supplied with the Company letter, being in the English language and lacking batch and expiry date prefixes.
3. The cartons contain an explanatory card, as provided with the Company letter dated October 16, 2013 which gives the circumstances behind the changed foils, as well as company contact details and a translation of the French text.
4. The Dear Healthcare Provider letter provided with the Company letter dated October 17, 2013 will be supplied with the non-compliant product. The document sets out the circumstances surrounding the supply of this batch; sponsor contact details; and a reminder for patients to keep the foil labels with the cartons.
5. The carton labels are as currently approved, except the batch and expiry details appear as an oversticker on the carton.