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Revision of the Australian code of good wholesaling practice for therapeutic goods for human use

Consultation

11 August 2006

This consultation opened on 4 July 2006 and closed on 11 August 2006.

Wholesaler distribution forms part of the supply chain for therapeutic goods. Wholesalers are responsible for the effective, efficient and safe handling, storage and distribution of such products along the supply chain. The Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use (November 1991) sets out steps for meeting this responsibility.

Historically the Code of Good Wholesaling Practice 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 resulting NCCTG document Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use (Draft Revision - June 2006) was released for stakeholder consultation in July 2006. The consultation document is still available:

How to access a pdf document

Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use (Draft Revision - June 2006) (pdf,119kb)

The draft revised Code incorporated a number of changes proposed previously by the National Pharmaceutical Services Association relating to the storage and distribution of temperature sensitive goods, and other changes relating to security of goods (particularly controlled drugs and other goods with high illicit-value) and facilities, personnel requirements and controlled conditions of transportation and delivery. The draft revised Code continued to apply to all classes of therapeutic goods. For clarity, definitions of 'wholesaler' and 'wholesaling' were included, with the definition of 'wholesaler' including centralised purchasing authorities and pharmacy buying groups, and 'wholesaling' including the transportation of goods from the wholesale premises to the customer.

Stakeholder comments were considered by the TGC at its 29th meeting held on 7 September 2006. Further development of the Code is expected and stakeholders will be engaged appropriately in this process.