chapter  2
29 Pages


ByC. T. Hung, D. Ren, L. A. Folland, F. C. Lam, Noelyn Anne Hung, R. Smart

History In Australia, as in many other countries, registration of medicines prior to their sale became a legal requirement soon after the problems with thalidomide (1) were identified. At present, the registration of medicines is controlled by the Therapeutic Goods Act 1989 (2). Under this Act, all medicines sold across state borders, prescription medicines and any nonprescription medicines intended for inclusion in the Pharmaceutical Benefits Schedule (PBS), cannot be sold until they are either registered or listed on the Australian Register of Therapeutic Goods (ARTG) ( Responsibility for inclusion or otherwise of medicines on the ARTG rests with the Therapeutic Goods Administration (TGA) based in Canberra. Prior to the Therapeutic Goods Act 1989, only prescription medicines and nonprescription medicines intended for inclusion in the PBS were evaluated. Nonprescriptionmedicines not intended for inclusion in the PBS and medicines manufactured and sold within a single state or territory did not need to receive formal regulatory approval before being sold except in some states such as the state of Victoria, where registration dubbed “Reg. Vic” by the Victorian Ministry of Health was required. Hence, in most states, no controls on the quality, safety, or efficacy of such medicines were enforced. “Reg. Vic” requirements related to good manufacturing practices (GMP) compliance of the finished product manufacturer along with evaluation of the quality and labeling of the finished product. With the coming into effect of the Therapeutic Goods Act 1989 on the January 15, 1991, these “Reg.Vic” requirements developed some time later into the OTC compliance branch of the TGA. From July 1, 2006, it was intended that all medicines, irrespective of scheduling, site of manufacture or distribution receive regulatory approval from a proposed Trans-Tasman Joint Regulatory Authority before being permitted for sale. The Joint Agency was to have responsibility for control of medicines in both Australia and New Zealand such that both countries were to be viewed as a single regulatory market, without being a single sales market. However in July 2007, the Labor party in the New Zealand Government at that time, failed to achieve sufficient votes to ratify the legislation designed to give authority to the agency. Establishment of the

Joint Agency has, therefore been postponed and no indication is presently available as to when such an agency will come into being. Therefore until such time as negotiations recommence, the status quo applies with the Therapeutic Goods Act 1989 being the applicable legislative authority. Continuation of registration or listing on the ARTG requires payment of an annual fee and no evaluation occurs with such payment. In relation to the sale of generic medicines, substitution, at the discretion of the dispensing pharmacist or at the request of the end user, on prescription is legal in Australia.