Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - from 26 May 2014

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On May 26 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                      Roche Products Pty Ltd, gave consent to the importation and supply, of:

• levodopa/Benserazide (as hydrochloride) (MADOPAR RAPID) 62.5 mg tablet bottle                 [AUST R 59577]
• levodopa/Benserazide (as hydrochloride) (MADOPAR RAPID) 125 mg tablet bottle                   [AUST R 59576]

that does not conform with the requirements of the BP 2014 monograph for Dispersible Co- beneldopa Tablets, in that the approved limits for impurity R0 08-1580/001 (BP impurity B) of NMT 0.8% (release) and NMT 1.0% (NMT 1.0%) exceed the limit of NMT 0.5% for any unspecified impurity described in the BP monograph.

The consent is effective from May 26, 2014 until further notice.  

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The limits for Impurity B in the products are MNT 0.8% (release) and NMT 1.0% (expiry).