THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On February 28 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 tiotropium (SPIRIVA) 18 micrograms powder for inhalation (in capsule) blister pack [Aust R 81525] by Boehringer Ingelheim Pty Ltd, North Ryde NSW, (“the Company”);
That does not conform with paragraphs 3(2)(h) & 3(2)(i) of Therapeutic Goods Order (TGO) 69, in that the batch number and expiry date prefixes printed on the blister foils do not immediately precede the respective batch number and expiry date.
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 to supply applies to the batches listed in the tables below.
- Stock currently in the warehouse:
Pack size | Quantity | Batch Numbers |
10 | 12,300 | 259326C, 260763A |
30 | 286,873 | 260763B, 261159A |
- Stock currently in transit to Australia:
Pack size | Quantity | Batch Numbers |
10 | 22,440 | 260763C, 262367A |
30 | 317,850 | 261663A,261664A |
2. The foil labels subject to this consent to supply are identical to those provided with the submission from the Company dated February 8 2013; the batch number and expiry date prefixes printed on the foils do not immediately precede the respective batch number and expiry date, but are nonetheless present.
3. No other changes have been made to the product tiotropium (SPIRIVA) 18 micrograms powder for inhalation (in capsule) blister pack [Aust R 81525].
4. The Dear Pharmacist letter provided with the email from the Company of February 6 2013, which sets out the circumstances surrounding this consent to supply and reminds patients to keep the blister strips with the outer carton, will be supplied with affected batches of product.