Christopher Pyne (Sturt, Liberal Party, Parliamentary Secretary to the Minister for Health and Ageing) Share this | Link to this | Hansard source

I move:

That this bill be now read a second time.

I am pleased to introduce the Therapeutic Goods Amendment Bill (No. 3) 2006.

It is a very straightforward bill. The amendments provided for in this bill are necessary to allow or require manufacturers of medicines, blood and tissues to apply for a manufacturing licence electronically using the TGA’s e-business system. As a result of the implementation of this amendment, manufacturers will be able to monitor progress with their licence applications and electronically submit requests for changes to their licences.

Paragraph 37(1)(a) of the Therapeutic Goods Act 1989 currently specifies that an application for a manufacturing licence must be made in writing in accordance with a form approved by the secretary. In October 2004, the TGA implemented a new computerised system for managing licence applications, the conduct of good manufacturing practice audits and other licence issues. This new Manufacturer Information System (MIS) was designed to allow for electronic licence application. This amendment is required to enable this function to be utilised. It is expected that the majority of applications for manufacturing licences will be lodged electronically.

The electronic licence application does not require any information beyond that already required by the approved paper application. The electronic application form is also designed to allow documentation requested to accompany the application to be submitted electronically.

Electronic applications for manufacturing licences will facilitate the speedy submission of applications by manufacturers and the efficient handling of applications by the TGA.

Debate (on motion by Mr Griffin) adjourned.