THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 13 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 the following:
(a) the supply by Boehringer Ingelheim Pty Ltd North Ryde, NSW (“the Company”) of the following products:
- pramipexole hydrochloride (SIFROL) 250 microgram tablet blister pack [AUST R 66484]
- pramipexole hydrochloride (SIFROL) 125 microgram tablet blister pack [AUST R 67238]
- pramipexole hydrochloride (SIFROL) 1.0 mg tablet blister pack [AUST R 66485]
- meloxicam (MOBIC) 7.5 mg tablet blister pack [AUST R 77694]
- meloxicam (MOBIC) 15 mg tablet blister pack [AUST R 77695]
(b) that do 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 foil labels do not immediately precede the respective batch numbers 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:
- The consent to supply applies to the batches and products listed in table below, as advised with the email from the Company dated March 12 2013.
Stock currently in the warehouse
AUST R | Strength | Pack size | Quantity | Batch Numbers |
66484 | 250 µg | 100 | 5,144 | 205377 |
67238 | 125 µg | 30 | 17,047 | 204600-R, 205741 |
66485 | 1.0 mg | 100 | 371 | 203665 |
77694 | 7.5 mg | 30 | 939 | 244729 |
77695 | 15 mg | 30 | 18,540 | 144971, 244708, 244737 |
Stock currently in transit to Australia
AUST R | Strength | Pack size | Quantity | Batch numbers |
66484 | 250 µg | 100 | 18,528 | 207864, 207863, 301683 |
67238 | 125 µg | 30 | 16,991 | 207757 |
66485 | 1.0 mg | 100 | 3,248 | 207866 |
77694 | 7.5 mg | 30 | 38159 | 244963,244963A,344052, one batch not yet assigned numbers. |
77695 | 15 mg | 30 | 56,730 | 244965, 244966, 344055, 344054, 344069 |
2. The foil labels subject to this consent to supply are as provided with the submissions from the Company; 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 products.
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 products.