Joint TGA and Medsafe project: Trans-Tasman early warning system of safety concerns with medicines and medical devices

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On 8 March, the Therapeutic Goods Administration (TGA)released a consultation document titled – The Trans-Tasman early warning system: How the process will work in Australia and New Zealand. The TGA are now seeking comments and input from interested parties on the proposed process and example web pages for an early warning system for medicines and medical devices. Medsafe is running a parallel consultation. This scheme will operate in parallel in Australia and New Zealand. Comments will be used to inform the process for both countries. On 8 March, TGA published a consultation document titled – The Trans-Tasman early warning system: How the process will work in Australia and New Zealand. Interested parties should respond by close of business 7 April 2013. This discussion paper outlines a description of the proposed process for a parallel early warning system for safety concerns with medicines and medical devices in Australia and New Zealand. Example web pages including hypothetical safety communications are included in the consultation. Through the consultation process, the TGA and Medsafe are seeking comments from interested parties on the: proposed webpages presentation of the hypothetical examples proposed communication channels. Content of submissions A copy of the discussion paper is available at: http://www.tga.gov.au/pdf/consult/consult-anztpa-early-warning-system-130308.pdf

TGA, 8 March 2013 ;http://www.tga.gov.au/ ;