Consent pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Servier Laboratories Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 29 July 2015, a delegate of the Secretary of the Department of Health, on the application of Servier Laboratories Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of

• perindopril erbumine (PERINDO 2 MG) 2 mg tablet blister pack [AUST R 121747]
• perindopril erbumine (PERINDO 4 MG) 4 mg tablet blister pack [AUST R 121748]
• perindopril erbumine (PERINDO 8 MG) 8 mg tablet blister pack [AUST R 121749]
• perindopril erbumine (INDOSYL MONO 2) 2 mg tablet blister pack [AUST R 198356]
• perindopril erbumine (INDOSYL MONO 4) 4 mg tablet blister pack [AUST R 198357]
• perindopril erbumine (INDOSYL MONO 8) 8 mg tablet blister pack [AUST R 198358]
• perindopril erbumine (PERINDOPRIL ACTAVIS 2)2 mg tablet blister pack [AUST R 212715]
• perindopril erbumine (IDAPREX 2) 2 mg tablet blister pack [AUST R 34266]
• perindopril erbumine (IDAPREX 4) 4 mg tablet blister pack [ AUST R 34267]
• perindopril erbumine (IDAPREX 8) 8 mg tablet blister pack [AUST R 96738]

that do not conform with the requirements of paragraph 3(2)(h) and (i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69), in that the batch and expiry details on blisters are not preceded by the appropriate prefixes.

The consent is effective from 29 July 2015 until the batches specified are exhausted.

The consent is subject to the following conditions:

1. A ‘Dear Pharmacist’ letter containing text identical to that provided to the Therapeutic Goods Administration on 28 July 2015 (TRIM reference R15/596764) advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches.

Batches to which this consent applies