TGA News Issue 51 (November 2006) - General news
Advertising code
The Therapeutic Goods Advertising Code 2006 took effect on 19 July 2006 and is available from the ComLaw Internet site <http://www.comlaw.gov.au>.
Australia-US free trade agreement
The Australia-US Free Trade Agreement came into force on 1 January 2005. Australia's obligations under the Agreement have been implemented by the US Free Trade Agreement Implementation Act 2004.
Amendments made by the Therapeutic Goods Amendment Act (No.2) 2006 have restricted the application of the patent certification requirements. These amendments commenced on 3 April 2006. See: Australia-US Free Trade Agreement <http://www.tga.gov.au/international/usfta.htm> for more details on what these changes mean for sponsors.
Customs labelling reminder
Sponsors are reminded that product labels may need to comply with requirements additional to those regulated by the TGA. As an example, Australian Customs has asked the TGA to remind importers of labelling requirements contained in their legislation.
Under the Commerce (Trade Descriptions) Act 1905 and Commerce (Imports) Regulations 1940 all medicines and medicinal preparations for internal and external use are prohibited for import into Australia unless there is applied to these goods the name of the country in which the goods were made or produced and a true description of the goods. This information must be in the English language. Where goods are found by Customs to contravene Regulations 7 and 8, importers will be required to re-label the goods before they can be released from Customs control.
More information can be found in the Australian Customs Notice 2006/39 (pdf,70kb) <http://www.customs.gov.au/webdata/resources/notices/ACN0639.pdf> or you can contact Customs by email at iprights@customs.gov.au.
Fees & payments
TGA fees & charges have recently been updated and the new amounts apply from 11 August 2006 <http://www.tga.gov.au/docs/html/feesach.htm>.
Annual charges were due for payment on 15 October 2006. Outstanding payments are now overdue.
Good wholesaling practice
The TGA has recently undertaken stakeholder consultation on a draft revision to the document Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use (November 1991). The June 2006 draft revision, which was released for public comment in July 2006, sets out the steps required of wholesalers in meeting their responsibility for the effective, efficient and safe handling, storage and distribution of therapeutic goods along the supply chain.
Historically the Code has been published by the TGA on behalf of the States and Territories, which are responsible for the licensing of wholesalers and application of the Code through their various legislative or licensing arrangements. Review of the Code was requested by the National Coordinating Committee on Therapeutic Goods (NCCTG), which consists of representatives of the States and Territories as well as the Commonwealth, and was undertaken through a special working party convened by the Therapeutic Goods Committee (TGC).
The consultation has now closed and stakeholder comments have been considered by the TGC <http://www.tga.gov.au/docs/html/tgc/tgc29.htm>. Further development of the document is expected and stakeholders will be engaged appropriately.
The draft revision released for stakeholder consultation in July 2006 is still available <http://www.tga.gov.au/consult/2006/cgwp-dr.htm>.
NDPSC update
Available on the TGA website are:
- National Drugs and Poisons Schedule Committee statement on the scheduling of potassium chloride <http://www.tga.gov.au/media/2006/061018-potassium.htm>
- A draft scheduling/rescheduling template
- Updated NDPSC guidelines <http://www.tga.gov.au/ndpsc/ndpscg.htm>
- Gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> associated with the October 2006 and the June 2006 meetings of the NDPSC and the record of reasons <http://www.tga.gov.au/ndpsc/records.htm> for the June 2006 meeting
Recalls
One consumer-level medical device recall has occurred since the last issue of TGA News <http://www.tga.gov.au/recalls/index.htm>.
TGA business plans
The TGA Business Plan 2006-2007 <http://www.tga.gov.au/about/tgabp0607.htm> is an integral part of the framework that will guide the work of the TGA during the 2006-2007 financial year.
Also now available is the April-June quarterly report against the 2005-2006 business plan <http://www.tga.gov.au/about/tgagorbp0506.htm>.