COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On September 25 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”), by application of AbbVie Pty Ltd, gave consent to the importation and supply, of:
- palivizumab (SYNAGIS) powder for injection 50 mg/0.5 mL (reconstituted) per vial with diluent ampoule [AUST R 68289]
- palivizumab (SYNAGIS) powder for injection 100 mg/mL (reconstituted) per vial with diluent ampoule [AUST R 68290]
that does not conform with the requirements of clause 3(2)(l)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the previous address (32-34 Lord St, Botany, NSW 2019) of the Sponsor or Supplier of the goods is present on the labelling used for containers and primary packs used to pack the Products.
The consent is effective from September 25, 2014 until September 1, 2016.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- That the labels to be supplied are those which contain the previous address (32-34 Lord St, Botany, NSW 2019) of the sponsor.
- Arrangements are in place for the forwarding of material sent to the previous Botany address to the current sponsor address. Services such as medical information, customer enquiries, pharmacovigilance activities and customer complaints will continue to be provided, and contingencies will be put in place to ensure any communications with the previous address will be forwarded to the new address.