National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 108 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 108 of 2008

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 3^rd NOVEMBER 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences at 11.59 pm on 30 November 2008.

2              Amendment of PB 74 of 2008

Schedule 1 amends PB 74 of 2008.

Schedule 1        Amendments

[1]       Schedule 1, item dealing with Risperidone

omit from “Column 3”:

In respect of the tablet 1 mg and tablet 1 mg (orally disintegrating):  

and substitute:

In respect of the tablet 1 mg, tablet 1 mg (orally disintegrating) and oral solution 1 mg per mL, 100 mL:

[2]       Schedule 1, item dealing with Risperidone

omit from “Column 3”:

In respect of the tablet 3 mg, tablet 3 mg (orally disintegrating), tablet 4 mg, tablet 4 mg (orally disintegrating) and oral solution 1 mg per mL, 100 mL:                   

and substitute:

In respect of the tablet 3 mg, tablet 3 mg (orally disintegrating), tablet 4 mg and tablet 4 mg (orally disintegrating):          

[3]       Schedule 1, item dealing with Risperidone

omit from the columns in the order indicated:

In respect of the oral solution 1 mg per mL, 30 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
2061	Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful
2598	Treatment under the supervision of a paediatrician or psychiatrist, in combination with non-pharmacological measures, of severe behavioural disturbances in a child or adolescent aged less than 18 years with autism, where behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful, and where the diagnosis of autism has been made based on either the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or the ICD-10 international classification of mental and behavioural disorders