Improved access to prescribing and consumer information​ The TGA is also committed to enhancing its dissemination of important benefit–risk information for medicines. Legislation amendments enacted in 2009 have expanded the range of regulatory information the TGA may release, while protecting commercially sensitive and personal information. This will allow the TGA to publish on its website recommendations from external advisory committees and summary decision statements on evaluations of prescription medicines. Over the next 12 months, the TGA will be progressively publishing a variety of documents on its website: * Product information (PI) – this document contains a concise scientific summary of what is known about a medicine, targeted at healthcare professionals * Consumer Medicines Information (CMI) – this document presents information about the use and safety of a medicine in lay language * Australian Product Assessment Report (AUSPAR) – this document contains detailed technical and scientific assessments of the efficacy, safety and benefit–risk of the medicine undertaken by the TGA and the considerations that led the TGA to approve or reject an application. An AUSPAR will be prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extension of indications. When this project is completed, the TGA website will provide a single point at which healthcare professionals, consumers and other interested parties can locate current, authoritative and reliable information about a medicine that is registered on the Australian Register of Therapeutic Goods (ARTG). Hot news – experience with swine flu vaccine www.tga.gov.au/alerts/medicines/h1n1vaccine1.htm The Blue Card system is not changing The cornerstone of medicines safety monitoring is spontaneous adverse event and incident reporting, so it's important that you continue to report adverse reactions to the TGA's Office of Medicines Safety Monitoring (OMSM). The Blue Card system has been in operation for more than three decades and has result...

Medicines Safety Update