Jill Hall (Shortland, Australian Labor Party) Share this | Hansard source

Any time! Mr Deputy Speaker, this legislation provides a statutory basis for the current practice of the secretary approving product information for prescription medicines as part of the registration process and, for the latter, variation of approved product information. It provides a clear statutory basis for the secretary to vary entries in the register for registered and listed goods, medical devices and biologicals, and to charge fees in relation to requests for such variations. Being a member of the Standing Committee on Health and Ageing for a number of years, I know how important that flexibility is.

This legislation supports the implementation of the business review process for prescription medicines by ensuring that the secretary can prescribe relevant documents and information that must be provided in applications for registration of prescription medicines and requests for variation of those entries. The time frames within which such documents and information is required reflects what has been agreed with the sponsor. The evaluation by the TGA of applications for registration of prescription medicines can continue even if an applicant has not provided all the documents and information requested during the evaluation by the secretary within the agreed time frames. It also ensures that the offence of failing to comply with a request from the secretary to provide information on documents does not apply to requests for application for registration or listings but only when a request is made to those who currently have goods on the register or who have had goods on the register in the previous five years. This corrects a drafting error.

The legislation also clarifies the power of the minister to determine what ingredients can be included in lists of medicines and the criteria that must be taken into account if a person requests a variation to the list of such ingredients. It also ensures that the secretary can determine that particular goods continue to be treated as therapeutic goods in appropriate cases even if a food standard is made when such goods or their status as a food or therapeutic good is otherwise not clear. There has been community consultation on this legislation. Similar legislation was introduced in the previous parliament. It is non-controversial legislation. It is legislation that will benefit the community as a whole and I commend the legislation to the House.

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