Proposed changes to the regulatory requirements for hospital, household and commercial grade disinfectants

Consultation

12 March 2008

This consultation closed on 28 April 2008.

Background

The TGA in collaboration with the National Industrial Chemicals Notification and Assessment Scheme is seeking comments on proposed changes to the regulation of hospital, household and commercial disinfectants as detailed in the consultant's report entitled "A new regulatory framework for disinfectants". It is proposed to hold stakeholder information sessions in the fortnight commencing 31 March 2008 and those interested in attending an information session are asked to send an Expression of Interest form by 14 March 2008.

Stakeholder letter

The following letter was mailed out to stakeholders in February 2008.

Dear Stakeholder

Proposed changes to regulatory requirements for hospital, household and commercial grade disinfectants

This is to seek your comment on proposed changes to the regulation of hospital, household and commercial grade disinfectant products as detailed in the attached consultant's report entitled "A new regulatory framework for disinfectants".

In response to a recommendation in the Australian Government's Report of the Taskforce on Reducing Regulatory Burdens on Business (Banks report, January 2006), NICNAS and the TGA engaged Dr Simon Brooke-Taylor to review the current Australian regulatory framework for disinfectant products and review the regulation of disinfectants in comparable overseas countries to assist in identifying best practice models.

The TGA and NICNAS would welcome your comments on the proposals in the report, in particular, the consultant's recommendation 3 as the preferred option for a new regulatory framework for disinfectants in Australia.

NICNAS and the TGA are also seeking information to allow preliminary assessment of the regulatory impact of this proposal, as required under Government best practice regulation policy. Specifically information is sought on potential business compliance costs and impacts on business and individuals, including restrictions on competition. It is therefore requested that the 'business impact checklist' included at the end of this letter also be completed and returned with your comments on this proposal.

In addition, it is proposed to hold stakeholder information sessions, in the fortnight commencing 31 March 2008 to allow further discussion on the regulatory proposal.

Submission of comments

Your comments on the proposed legislative amendments for disinfectants, particularly your advice on whether you support option 1 in the consultants report, as well as comments on possible financial implications for moving to this new model, would be appreciated by cob 28 April 2008. If you have any enquiries about this proposal please contact:

Comments may be sent by email to the above addresses, or by mail, and should include your full contact details. The mailing address for comments is:

Ms Siepie Larkin
MDP 122
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Australia

All comments submitted will be placed on the TGA and NICNAS websites and be publicly available.

Stakeholder information sessions

For those interested in attending a stakeholder information session can you please complete the attached 'expression of interest' form and return it by fax to (02) 8577 8888 or by mail to the address on the form by 14 March 2008 information sessions will be held before the close off date for submission of comments. Currently sessions are planned for Sydney and Melbourne, however, if there is sufficient interest in other locations then consideration will be given to holding meetings elsewhere. It is important that the expression of interest form is returned with completed contact details. NICNAS will contact all persons returning the form to advise them of meeting locations and times, details of which will also be advertised in local newspapers and on the TGA and NICNAS web-sites.

All comments made at public information sessions will be placed on the TGA and NICNAS websites and be publicly available.

Yours sincerely

Rita Maclachlan
Director
Office of Devices Blood and Tissues

Dr Marion Healy
Director
NICNAS

February 2008

Consultant's report

How to access a pdf document

A new regulatory framework for disinfectants (pdf,331kb)

Information sessions

• Stakeholder presentation on the proposed changes to the regulatory requirements for hospital, household and commercial grade disinfectants (pdf,410kb)

The following letter was mailed out to stakeholders in March 2008.

Dear Stakeholder

Stakeholder Consultation Sessions
Proposed changes to regulatory requirements for hospital, household and commercial grade disinfectants

Further to the letter from Ms Rita Maclachlan and Dr Marion Healy, dated 25 February 2008, regarding proposed changes to the regulatory requirements for disinfectants, below please find the details of the planned stakeholder information sessions to be held to allow further discussion on the regulatory proposal.

SYDNEY			MELBOURNE
Date	Tuesday 1 April 2008		Date	Monday 7 April 2008
Time	10.00am - 12.00 noon or 7.00pm - 9.00pm		Time	10.00am - 12.00 noon or 7.00pm - 9.00pm
Location	Mercure Hotel 818-820 George St Sydney		Location	Novotel Hotel on Collins 270 Collins St Melbourne
Phone	02 9217 6666		Phone	03 9667 5800

If you are interested in attending one of these public information sessions please contact me on phone: 02 6232 8721 or email: siepie.larkin@tga.gov.au by COB 28 March 2008 for the Sydney sessions or COB 3 April 2008 for the Melbourne sessions.

Yours sincerely
Siepie Larkin
Regulatory Reform Devices
Office of Devices Blood and Tissues

19 March 2008

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