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Prescription medicines business process reform project
This will be achieved by facilitating access to a comprehensive source of up to date Consumer Medicine Information (CMI) and Product Information (PI). This is designed to:
- provide a single trusted source of all PI and CMI documents
- support greater transparency of the regulatory process
- be consistent with best international regulatory practice.
The functionality is now available in the TGA eBusiness Services IT system (eBS) for sponsors to lodge the CMI and PI for their products to the TGA.
Sponsors are advised that:
- PI and CMI documents must be in text PDF format - please be aware that scanned PDF documents will not be accepted by the system.
- CMIs are not required where the product is not supplied in the Australian market.
- as sponsors will be lodging the documents with the TGA directly, it is no longer necessary to also email the documents to email@example.com.
Existing prescription medicines
From November 2009 a back capture of existing PI and CMI documents has been progressing. It is estimated that between 9,000 - 11,000 PI/CMI documents need to be initially back captured via this process. Sponsors have been advised to contact the TGA if they believe that they would not be able to meet the required timeframe of 28 February 2010 to lodge:
- PI documents for all the prescription medicine products that they sponsor
- CMI documents for the products that are supplied in the Australian market.
The TGA is working to develop an electronic interface for the loading of PI and CMI documents by third parties. This work is being done on behalf of those sponsors who have opted to use third parties to load their PI and CMI documents onto the TGA website. As this electronic interface is not yet finalised, it is recognised these sponsors can not meet the 28 February 2010 deadline. For this reason, compliance checking of the availability of PI and CMI documents will not commence until the service has been successfully implemented and the relevant PI and CMI documents have been loaded via this facility.
Newly approved prescription medicines
For submissions approved from 1 March 2010 the:
- Product Information (PI) document(s) approved by the TGA must be lodged with the TGA within 2 weeks of the date of registration of the product/s, and
- related Consumer Medicine Information (CMI) document(s) must be lodged with the TGA:
- for new product/s - prior to supply of the product/s
- for variations to existing products - within 2 weeks of the date of approval of the variation.
The documents may be lodged by either:
- lodging the documents in the TGA eBusiness Services system (eBS) - information on how to lodge these documents is available on eBS
- using the healthlinks.net electronic facility (relevant only for those sponsors who have chosen this path for lodging their PI and CMI documents onto the TGA website).
Note that documents lodged must be in text PDF format - please be aware that scanned PDF documents will not be accepted by the system.
- Proposed changes to Product Information (PI)
Consultation on proposal for only one product information document to be approved and published for each prescription medicine product. Closing date: 26 July 2010