Therapeutic Goods (Listing) Notice 2009 (No. 4) (Cth)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No. 4)

I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the ARTG) for listed goods:

• preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) that contain, as their therapeutically active ingredient, sodium bicarbonate for oral rehydration therapy, subject to the following conditions:

o   the formulation complies with the requirements specified in the British Pharmacopoeia monograph for Oral Rehydration Salts;

o   the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the following criteria, as specified by the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) in the document, ‘Expert consultation on oral rehydration salts formulation, 18 July 2001’.

COMPONENT	CONCENTRATION
Sodium	60 – 90 mEq/l
Glucose	At least equal that of sodium and less than 111 mmol/l
Potassium	15 – 25 mEq/l
Total Osmolarity	200 - 310

o   the product label includes the following advisory statements:

-    “Use only as directed”, and

-   “If diarrhoea persists, seek medical advice”; and

o   the product label includes a description of the symptoms of dehydration for the benefit of consumers;

o   the proposed directions for use must be clearly outlined on the label; and

o   when indicated for use in children, the directions for use on the product label includes the following additional directions:

Age of child	Additional Directions
Under 6 months	Medical advice should be sought if diarrhoea persists for more than 6 hours.
Under 3 years	Medical advice should be sought if diarrhoea persists for more than 12 hours.
3-6 years	Medical advice should be sought if diarrhoea persists for more than 24 hours.
Over 6 years	Medical advice should be sought if diarrhoea persists for more than 48 hours.

This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.

Pursuant to subsection 9A(6) of the Act this Notice ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods.

Dated this     1^st    day of September 2009

[signed by]

Rohan Hammett

Delegate of the Minister for Health and Ageing