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 128 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 128 of 2009

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, ROGER BUSCH, 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 21 December 2009

ROGER BUSCH

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 February 2010.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

[1]         Schedule 1, omit item dealing with Bifonazole

[2]         Schedule 1, item dealing with Glucose Indicator—Blood

insert in the column headed “Circumstances” after (Betachek G5), :

test strips, 50 (Bionime Rightest),

[3]         Schedule 1, item dealing with Hydromorphone

omit from the column headed “Circumstances”:

In respect of the tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg:

Chronic severe disabling pain not responding to non-narcotic analgesics

and substitute:  

In respect of the tablet (modified release) containing hydromorphone hydrochloride 4 mg, tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg:

Chronic severe disabling pain not responding to non-narcotic analgesics

1. Schedule 1, item dealing with Influenza Vaccine

omit all text from the column headed “Circumstances” and substitute:

In respect of the injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe:

Children up to 35 months of age at increased risk of adverse consequences from infections of the lower respiratory tract

In respect of the injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 15 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 15 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe:

Persons at special risk of adverse consequences from infections of the lower respiratory tract

1. Schedule 1, omit item dealing with Silver Sulfadiazine with Chlorhexidine

1. Schedule 2, item dealing with Hydromorphone

omit from the column headed “Circumstances”:

In respect of the tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg:

Chronic severe disabling pain not responding to non-narcotic analgesics

and substitute:

In respect of the tablet (modified release) containing hydromorphone hydrochloride 4 mg, tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg:

Chronic severe disabling pain not responding to non-narcotic analgesics

1. Schedule 3, omit item dealing with Chlorhexidine

1. Schedule 3, omit item dealing with Silver Sulfadiazine