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 86 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 86 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, LINDA JACKSON, 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 September 2009

LINDA JACKSON

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 October 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

1. Schedule 1, item dealing with Methylphenidate

omit from the column headed “Circumstances”:

Treatment of attention deficit hyperactivity disorder (ADHD) in a patient aged 6 to 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 12 hours

In respect of the capsule containing methylphenidate hydrochloride 20 mg (modified release), capsule containing methylphenidate hydrochloride 30 mg (modified release) and capsule containing methylphenidate hydrochloride 40 mg (modified release):

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of attention deficit hyperactivity disorder in a patient aged 6 to 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 8 hours

and substitute:

Treatment of attention deficit hyperactivity disorder (ADHD) in a patient diagnosed between the ages of 6 and 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 12 hours

In respect of the capsule containing methylphenidate hydrochloride 20 mg (modified release), capsule containing methylphenidate hydrochloride 30 mg (modified release) and capsule containing methylphenidate hydrochloride 40 mg (modified release):

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of attention deficit hyperactivity disorder (ADHD) in a patient diagnosed between the ages of 6 and 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 8 hours

1. Schedule 1, item dealing with Oestradiol

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

―

1. Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone

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

―

1. Schedule 1, item dealing with Oestradiol with Norethisterone

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

―