Manufacturer's Information System for GMP audits and manufacturer's clearances
November 2004
Over the last two years the TGA has been progressively converting its various systems to an e-business format. The aim has been to present a more efficient process for both clients and the TGA in processing the differing types of applications made to the various areas of the TGA.
The next of these systems to come online will support the Manufacturer Assessment Section of the TGA (previously known as GMPALS - GMP Audit and Licencing Section). The new system will do away with paper forms and allow for electronic application for -
- Manufacturing licences for medicinal products
- Certification by audit of overseas medicines manufacturers
- Variations to each of the above
- Clearance Certification of overseas medicines manufacturers by assessment of GMP evidence provided by an overseas regulatory body
The system, called Manufacturer Information System (MIS), is a component of the larger TGA online services system, and is designed to provide a web-based interface between the TGA's clients and the Manufacturer Assessment Section of the TGA.
In addition, the published list of Australian Manufacturers Licenced to Manufacture Therapeutic Goods - commonly referred to as the 'Blue Book' will be available online in the same way the system makes available a public version of the Australian Register of Therapeutic Goods.
This new system was introduced on 11 October 2004. Whilst sponsors and manufacturers are strongly encouraged to use the electronic system, paper applications will continue to be accepted under exceptional circumstances. However, these may take longer to process. Electronic applications will need to be made through TGA online services at: www.tgasime.health.gov.au.
Most clients will already be familiar with the e-business systems of the TGA, having used some of the current systems. For those clients there are no changes to your current practice - existing accounts will work with the new MIS system.
For those clients not familiar with TGA online services, a couple of steps are required in preparation for using these facilities.
To establish an e-business account with the TGA you need to:
- Visit the website www.tgasime.health.gov.au and enter the New Users area.
- Download the User Forms.zip file and extract the e-business and client details forms from the file.
- Complete and fax them both to the TGA on 02 6232 8581. Please note there is no requirement to send in the original forms, a fax copy is sufficient.
Within a couple of days of faxing these documents, you will receive 2 emails. One with your master e-business account the other being instructions to set it up. Using the master account you can log onto the user management area in SIME and establish the appropriate number of user accounts for your organisation.
If you have any trouble setting up your accounts please call the TGA SIME help desk on 1800 010 624.
1800 446 443 is the help line that has been established to provide user support when MIS is available. A User Manual can also down loaded once MIS is accessed using your password.
Education Sessions are being set up in November across Australia to discuss the new MIS system along with the new Export Electronic Lodgement System for the listing of export medicines onto the ARTG and for the request of export certificates. A Registration form, venues and further details will be posted on www.tgasime.health.gov.au and www.tga.gov.au.
The TGA will keep clients informed and up to date with news bulletins published in the What's New area of the TGA online services home page.