Manufacturer information system

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 supports the TGA Manufacturer Assessment Section (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 TGA Manufacturer Assessment Section.

This new system was introduced on 11 October 2004. While 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>.

The MIS delivers the following business and workflow benefits for both the TGA and the applicant.

• Manufacturing activities will be more clearly defined within the application.
• Applicants will be able to track the progress of all SIME-MIS applications as they progress through the system.
• Supporting documentation can be attached to an application and submitted electronically to the TGA, with a hardcopy submitted to the Manufacturer Assessment Section..
• The process of making variations or notification of changes to licences is simple and the requests are processed quickly.
• Enhanced processing times for applications and queries.
• An up-to-date copy of the "Blue Book", listing licensed Australian manufacturers, will be available online.

A help line (1800 446 443) has been established to provide user support for the MIS. A user manual can also downloaded once the MIS is accessed.

Education sessions are being held in November across Australia to discuss the MIS, along with the new Export Electronic Lodgement System for the listing of export medicines onto the ARTG and for the request of export certificates.

As with all the SIME systems, 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 website.

OTC medicines electronic lodgement system

The new OTC Medicines Electronic Lodgement System has been developed with the aim of improving turnaround times, increasing transparency for sponsors and enhancing the TGA's responsiveness. It is the final component of the online services development which has already delivered on a number of key objectives, including electronic access to the ARTG and client systems as well as electronic application lodgement for listed medicines, export only products, medical devices and manufacturer licences.

The ability for sponsors/agents to make OTC medicine product applications is planned to commence on 6 December 2004. Please note that the TGA will only continue to accept applications relating to OTC medicines generated using the current paper forms up to and including 28 January 2005. From 31 January 2005 all OTC medicines applications must be lodged electronically.

Demonstrations of the new system will be held in Sydney (8 December 2004) and Melbourne (9 December 2004). If you would like to attend one of the seminars, complete and return the registration form by 1 December 2004.

• More information on the OTC Medicines Electronic Lodgement System <http://www.tga.gov.au/online/opal.htm>