SOLTRADE - The Australian Sole Trader Transition Database

Currently, in Australia, the Therapeutic Goods Act 1989 enables the Therapeutic Goods Administration (TGA) to make decisions that apply nationally about the manufacture, supply, import, export and promotion of therapeutic goods. Activities that cannot be regulated by the Commonwealth due to constitutional restrictions are regulated by the States and Territories. Individuals who supply therapeutic goods only within a State or Territory (sole traders) are therefore not regulated by the TGA.

The Australian States and Territories have agreed for some time that sole traders should be subject to uniform legislative requirements and have agreed to enact legislation complementary to the Therapeutic Goods Act 1989. New South Wales, Victoria and Tasmania have already enacted complementary legislation that adopts the Therapeutic Goods Act 1989 by reference or other means. Other jurisdictions are at various stages of legislative development.

Australia and New Zealand have entered into a Treaty to establish a joint regulatory scheme for therapeutic products and a joint agency (the Agency) to administer the scheme. The Treaty between Australia and New Zealand will enable the Agency to regulate sole traders in Australia. Therefore, following commencement of the Agency, the Commonwealth will regulate sole traders and, at this point, State and Territory complementary legislation will no longer be required for matters covered by the joint scheme. The impact of the regulatory scheme on sole traders will vary depending on how they are currently regulated by the different jurisdictions.

Products that sole traders supply legally now will, in general, be given a transitional approval in the form of an interim product licence to supply within the jurisdiction in which the products are currently legally supplied, for the duration of a three year transition period. In other words, the interim product licence will only allow continued supply of product within the State or Territory border in which it is currently being lawfully supplied under State or Territory Regulations. Supply beyond the State or Territory border will require a full product licence from the Agency.

Sole traders who wish to continue supply beyond the end of the three year transition period, even within their State or Territory border, must apply to the Agency for a full product licence and must meet the requirements of the joint regulatory scheme.

Following agreement by States and Territories, the Joint Agency Establishment Group has created a central interim register (SOLTRADE) for sole traders to enter details of products they supply legally at present so that at the commencement of the joint scheme these products can be given an interim product licence until the sole trader applies for and is granted a full product licence under the Agency's regulatory scheme. Only those products notified on SOLTRADE will be issued with an interim product licence.

Following commencement of the joint scheme, persons who do not supply legally (for example, by advertising and supplying interstate or supplying products without an interim or full product licence) will be exposing themselves to enforcement action by the Agency.

When a person applies for a full product licence, the Agency will assess the product for compliance with the joint scheme. Compliance with the joint scheme will include the requirement that all medicines are manufactured in accordance with the code of good manufacturing practice and, if manufactured in Australia or New Zealand, by a licensed manufacturer.

To gain access to SOLTRADE, businesses or enterprises must register with the TGA. This is done by completing a Client Details form <http://www.tga.gov.au/docs/html/forms/clientdt.htm>. Additional details are included in the SOLTRADE User Guide <http://www.tga.gov.au/sime/soltrade.htm>.

If you have already been issued a Client ID number and password to access the TGA's Online Service applications <https:/www.ebs.tga.gov.au>, you may use your existing user name and password to access SOLTRADE.