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Medicine Shortages Information - The Protocol
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The Medicine Shortages Information Initiative has the goal of improving the communication and management of medicine shortages in Australia and is being led by the TGA, Medicines Australia (MA) and the Generic Medicines Industry Association (GMiA). This partnership has developed the Protocol. Participation by sponsors in the Initiative is voluntary.
The Protocol describes the roles of sponsors and the TGA in the communication and management of medicine shortages and is premised on the principles of:
- timely notification about changes in supply in the Australian market
- structured assessments of the likely impact when supply will not, or is anticipated not to, meet consumer demand1
- coordinated responses and communication in collaboration with other medicine stakeholders.
The Protocol also sets out the arrangements for the Medicine Shortages Information website (the Website). Hosted by the TGA, it is the key tool for delivering consolidated information to support health professionals and consumers when there is a medicine shortage.
This Protocol does not alter or replace current responsibilities of parties in managing medicine shortages.
1Consumer demand is the overall volume and timing needs of the consumer to access a specific medicine. For the purpose of medicine shortages, the assessment of the demand is limited to:
- the availability to the overall Australian market and not the separate distribution points
- the supply of the specific product and excludes considerations about the existence and availability of substitute medicines or therapeutic alternatives.