Federal Register of Legislation - Australian Government

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Notices & Notifications as made
This Notice has the effect of requiring that therapeutic goods containing 'deer velvet antler powder' and 'deer velvet antler slice' as therapeutically active ingredients in listed medicines, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods for listed goods.
Administered by: Health
General Comments: 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 Register for listed goods.
Registered 13 Oct 2011
Tabling HistoryDate
Tabled HR31-Oct-2011
Tabled Senate31-Oct-2011
Date of repeal 21 Oct 2016
Repealed by Therapeutic Goods (Repeal of Listing Notices) Notice 2016

EXPLANATORY STATEMENT

 

THERAPEUTIC GOODS (LISTING) NOTICE 2011 (NO. 2)

Deer velvet antler powder and deer velvet antler slice

 

Subsection 9A(5), Therapeutic Goods Act 1989

 

 

OUTLINE

 

Therapeutic Goods (Listing) Notice 2011 (No. 2) (the Listing Notice) is a notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

 

The Listing Notice has the effect of requiring that therapeutic goods containing ‘deer velvet antler powder’ and ‘deer velvet antler slice’ as therapeutically active ingredients in listed medicines, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.

 

The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).

 

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

 

Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included on the Register before being supplied in, imported into, manufactured in or exported from, Australia (sections 19B and 19D of the Act).  Medicines are registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.

 

In general, products that contain low risk ingredients are referred to as listed medicines in Australia.  Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk, and may only make limited therapeutic claims.

 

Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed medicines.  It does not currently cover preparations that contain deer velvet antler powder and deer velvet antler slice.

 

Subsection 9A(5) of the Act authorises the Minister for Health and Ageing to publish a notice in the Commonwealth of Australia Gazette, requiring specified goods to be included in the part of the Register for listed goods and allowing the Minister to specify conditions to which such an inclusion is to be subject.  Such notices generally require that goods containing particular ingredients be included in that part of the Register.  Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.

 

If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice be included in the part of the Register for listed goods the notice ceases to have effect (subsection 9A(6) of the Act).

 

A person can apply for a new ingredient or substance to be approved for inclusion as an active ingredient in listed medicines through the making of a subsection 9A(5) notice.  The TGA evaluates such applications and the supporting data provided by the applicant on the basis of safety and quality.  The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.

 

DEER VELVET ANTLER POWDER AND DEER VELVET ANTLER SLICE

Deer velvet antler has a very long and well-documented history of traditional use in Traditional Chinese Medicine (TCM), and has also been used therapeutically for many centuries in Russia, Japan and Korea.

 

The TGA is of the view that preparations containing deer velvet antler slice and deer velvet antler powder derived from the antlers (including the velvet) of red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species are appropriate for inclusion in that part of the Register for listed goods, subject to the following conditions.  These substances are to be sourced exclusively from stock bred and raised on farms in New Zealand to satisfy health requirements for human consumption in accordance with the Animal Products Act 1999 (New Zealand) and the regulations made under that Act, and from which the antlers are removed only according to the Animal Welfare Act 1999 (New Zealand) and the regulations made under that Act.  These conditions are applied to ensure the safety of the substances with regard to transmissible spongiform encephalopathies (TSEs), namely chronic wasting disease (CWD) to which deer elsewhere in the world have been linked, and agricultural and veterinary residues, including anaesthetics used during antler removal.

 

The delegate of the Minister for Health and Ageing has made the Listing Notice, which is a legislative instrument for the purposes of the Legislative Instrument Act 2003, to require that deer velvet antler powder and deer velvet antler slice be included in the part of the Register for listed goods, so long as they are sourced only from New Zealand-farmed stock under the conditions referred to in the previous paragraph. This will have the effect of permitting the use of deer velvet antler powder and deer velvet antler slice in oral listed medicines.

 

The TGA has also prepared a physico-chemical description of deer velvet antler powder and deer velvet antler slice in the form of compositional guidelines.  Compositional guidelines are intended to assist applicants for inclusion of therapeutic goods on the Register that are or include goods of the kind described in a subsection 9A(5) notice in identifying the specific forms or types of ingredients or substances where, as in this case, there is no standard in the British Pharmacopoeia or other acceptable monographs in relation to the ingredient or substance.

 

The draft compositional guidelines for deer velvet antler powder and deer velvet antler slice will be available on the TGA’s internet site (www.tga.gov.au) for consultation for six weeks from the date of registration of the Listing Notice.  The guidelines will then be published on the website in their final form. 

 

CONSULTATION

 

The making of the Listing Notice is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.