2006/07 annual charges

11 October 2006

This notice is a reminder that if you are a sponsor choosing to pay by quarterly instalment the 2006/07 annual charges, the due date for the first instalment is the 15 October 2006.

All requests for cancellation and application for low turnover products with the applicable fee must also be in by this date. Failure to meet this date will result in full payment of the annual charges.

• Sponsor cancellations must be made using the cancellation form available on our website: Authorisation to cancel a product from the Australian Register of Therapeutic Goods <http://www.tga.gov.au//fees/forms/artg-cancel.htm>.
• Low turnover products. Applications to declare that the turnover of a product is of low volume and low value in accordance with Regulation 4C of the Therapeutic Goods (Charges) Regulations 1990 should be submitted together with the applicable fee by the 15 August 2006.
• Applications to declare that the turnover of a product is of low volume and low value must be made on the forms available on our website: Application for declaration that turnover is of low volume and low value <http://www.tga.gov.au/fees/forms/lowvolume.htm>.

Payments

The instalment dates for payment of instalments in 2006-07 will be as follows:

Quarter 1	15 October 2006
Quarter 2	1 December 2006
Quarter 3	1 March 2007
Quarter 4	1 June 2007

• Failure to make an instalment payment by 15 October will forfeit the option of making instalment payments for the remainder of the year. The full amount of the invoice will be payable in immediatley. Failure to pay a subsequent instalment a the due date will also cause the balance of the account to fall due immediately.
• Online banking
  • The TGA has launched additional payment options during the first quarter of the new financial year. Sponsors will be able to make payments for annual charges online by credit card (for amounts up to $15,000) or by direct debit from a savings or cheque account. Online payment of annual charges by credit card or direct debit (Westpac website)

Liability for annual charges

Annual charges are imposed under Regulation 3 of the Therapeutic Goods (Charges) Regulations 1990 and represent a cost recovery tax. Annual charges are payable for any entry on the ARTG in respect of a financial year unless the product is declared to have a turnover that is of low volume and low value.

• Annual charges apply in respect of the financial year (or part there-of) and are not adjusted where a product entry or cancellation occurs during the year.
• The TGA has no power to waiver annual charges other than products declared to have a turnover that is of low volume and low value.
• Sponsors that have not advised the TGA of the cancellation of a product by 15 August each year will remain liable for the annual charge for the product(s) as these products will be deemed to have been an entry on the ARTG for 2006-07.
• Sponsors that cancel a product, or have a product suspended or cancelled by the TGA during the course of the year remain liable for any outstanding instalments that may be due on the product.

All enquiries regarding arrangements for 2006-07 annual charges should be directed to the TGA Revenue Manager on 02 6232 8264 or by email to TGA.Accounts@tga.gov.au.

ANZTPA update

A series of meetings about the Australia New Zealand Therapeutic Products Authority (ANZTPA), and the proposed regulatory scheme, were held for industry and other interested stakeholders in June 2006.

The meetings were held in both New Zealand and Australia and provided an opportunity for industry groups and other stakeholders to hear about the ANZTPA Establishment Project and the proposed regulatory scheme for prescription, over-the-counter (OTC) and complementary medicines and medical devices.

Presentations from these meetings are available on the ANZTPA website <http://www.anztpa.org>.

Business plan

The Therapeutic Goods Administration Business Plan 2006-2007 is available <http://www.tga.gov.au/about/tgabp0607.htm>. The Business Plan is an integral part of the framework that will guide the work of the TGA during the financial year. The Plan describes the functions and activities to be undertaken by the TGA during 2006-2007 and includes relevant qualitative and quantitative performance information.

Cost recovery impact statements

There are two cost recovery impact statements available:

• Annual review of fees and charges 2006-07 - non prescription (registered and listed) medicines <http://www.tga.gov.au/fees/cris-npfees06-07.htm>
• Regulation of in-vitro diagnostic devices <http://www.tga.gov.au/fees/cris-ivd.htm>

Definition of British Pharmacopoeia

From 1 July 2006 the definition of "British Pharmacopoeia" in the Therapeutic Goods Act 1989 is the British Pharmacopoeia 2005. <http://www.tga.gov.au/legis/bp2005.htm>

NDPSC update

Gazette notices associated with the February and June 2006 meetings of the National Drugs and Poisons Schedule Committee and the record of reasons for the February 2006 meeting are available. <http://www.tga.gov.au/ndpsc/ndpscgan.htm] & <http://www.tga.gov.au/ndpsc/record/rr200602.htm>

The NDPSC membership details <http://www.tga.gov.au/ndpsc/ndpscmem.htm> and meeting and gazettal dates <http://www.tga.gov.au/ndpsc/index.htm> have also been updated.

Recalls

One consumer-level medical device recall has occurred since the last issue of TGA News <http://www.tga.gov.au/recalls/index.htm>.

SUSDP No. 21

The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) No. 21 (a consolidation of SUSDP No. 20 and its three Amendments) has an effective date of 1 June 2006 and is available for purchase on subscription. The subscription form is available <http://www.tga.gov.au/ndpsc/susdp.htm>.

TGA News survey

We would like to obtain your views on TGA News and its future. There is a series of questions on the back of the address sheet that comes with the printed version of TGA News. This can be filled out and faxed to us or there is a version of the survey below that can be completed online and emailed to us.

The deadline for responses is 1 September 2006.

How to access an rtf document

TGA News survey (rtf,15kb)

Therapeutic goods orders

The Therapeutic Goods Regulations 1990 require the Therapeutic Goods Committee (the Committee) to advise the Minister on matters relating to standards for therapeutic goods.

As a step towards the establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA), the Committee has considered the status and relevance of existing standards for therapeutic goods. Therefore, the Committee has recently proposed the revocation of Therapeutic Goods Order No 8 "Standards adopted from the British Pharmaceutical Codex 1973" (TGO8) and Therapeutic Goods Order No 45 "Amendments of the Schedule to Therapeutic Goods Order No.8: 'Standards adopted from the British Pharmaceutical Codex 1973'"; (TGO45). To assist it to determine its final position, the Committee has requested that consultation be undertaken with stakeholders, including sponsors and industry associations, on the implications of revocation of TGO8, as amended by TGO45, for currently listed or registered products. In particular, the Committee seeks information on any specific difficulties for sponsors that may be associated with the revocation of TGO8 and TGO45.

The Committee noted that a small number of monographs for substances and formulations mentioned in TGO8 are now included in the British Pharmacopoeia. Upon revocation of TGO8 and TGO45, these substances and formulations would be required to comply with these specific monographs of the British Pharmacopoeia, as well as the general monographs of the British Pharmacopoeia where applicable

The majority of substances in TGO8 however are not included as monographs in the British Pharmacopoeia. Therefore upon revocation of TGO8 and TGO45, these substances could continue to use the British Pharmaceutical Codex 1973 (BPC 73) standard, or another standard acceptable to the TGA, as an in-house standard. The general monographs of the British Pharmacopoeia would apply to the particular dosage form.

The draft document lists the substances and formulations included in TGO8, as amended by TGO45, that are currently required to comply with the BPC 73. The draft document also provides Australian Approved Names where these are different to the terminology used in the BPC 73.

The status of substances and formulations in the British Pharmacopoeia 2005 and the United States Pharmacopoeia 29th edition is also included. Subject to the outcome of the current consultation on the draft Rules for the ANZTPA, it may be that the United States Pharmacopoeia will also become a default standard for some of the medicines covered by TGO8.

Stakeholder comment is therefore being sought on the impact of the revocation of TGO 8 and TGO45, and in particular, on any specific difficulties for sponsors that may be associated with this action.