Trans Tasman Harmonisation April 2002
Provided
by Robert Forbes & Associates Pty Ltd,
Sydney,
Australia
Trans Tasman Harmonisation has created much
discussion and also at times confusion. In response to requests from clients we
have tried to clarify a number of concerns that regularly arise on Trans Tasman
Harmonisation –
see full story for details. Please feel free to
contact Robert Forbes if you wish to discuss any of these items in further
detail.
TGA News
Medical Devices Bill
passed by Parliament
The
Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic
Goods (Charges) Amendment Bill 2002 were passed by Parliament on Thursday 21
March 2002. Implementation of the new regulatory framework for medical devices
will be end of September 2002. Industry seminars to be held
May/June on the new system – check website below for details.
http://www.health.gov.au/tga/docs/html/devbill.htm
Trans-Tasman
Harmonisation
Further to information presented in Issue 11 newsletter, we advise that a formal
discussion paper is due to be released by the Joint Agency in early May. In
August both Governments will consider the best way to establish the agency and
regulatory regime that it will administer. The precise regulatory controls will
be settled after considering submissions made on the May discussion paper
http://www.jtaproject.com
New Code of GMP for
Australia
The
TGC Subcommittee met on 25th February to decide the most appropriate Code to
replace the Australian Code of GMP. The two codes considered were PIC/S Guide to
GMP and EC Guide to GMP. The recommendation will be tabled at the April TGC
meeting.
Overseas GMP Preclearance Assessment Checklist
The
TGA has released a new checklist to help streamline the preclearance assessment
of overseas manufacturers.
http://www.health.gov.au/tga/docs/pdf/oscheck.pdf
Standards for
Ethanol
The
TGC has recommended the revocation of TGO 29
Standards for Ethanol. This would result in the current edition of the British
Pharmacopoeia (BP 2001) becoming the standard for Ethanol.
Child Resistant
Packaging TGO
The
TGC is working towards a new Therapeutic Goods Order (TGO) to specify standards
for child-resistant packaging used for therapeutic goods. A revised draft TGO
will be considered at the April TGC meeting.
TGA Publications
A revised list of new and updated
publications can be found at
http://www.health.gov.au/tga/pubs/pubs.htm
Practitioner Only Listed Medicines
Practitioner only goods must be Listed
or Registered on the Australian Register of Therapeutic Goods (ARTG).
Listed products supplied only to practitioners must comply with all the same
standards and requirements that apply to all Listed
medicines. The only special provision for 'practitioner only’ goods relate to
some labelling requirements. Claims made to practitioners for a product must be
as per the claims submitted to the TGA for inclusion on the
ARTG.
¨
EU Guidelines published as Adopted in Australia
Since October 2001, over 70 new and
replacement European Guidelines have been adopted in
Australia. For details see
http://www.health.gov.au/tga/docs/html/euguideh.htm
On 3rd April 2002, the following
product was issued a Class II Recall:
¨
Twin Lab Metabolic Enhancer
– Ripped Fuel – Mah Yuang
(Mahuang) Free Formula (Australian Sponsor – Green
Valley Nutrition Pty Ltd)
The product was supplied without
being included on the Australian Register of Therapeutic Goods. The product also
contains Yohimbine, a substance not approved for supply in Australia (Class II
defects “could cause illness or mistreatment, but are not Class I”. Class I
defects “are potentially life-threatening or could cause a serious risk to
health”).
http://www.health.gov.au/tga/docs/html/yuangrec.htm