Streamlining and improving therapeutic goods legislation

The amendments made to the Therapeutic Goods Act 1989 - external site (the Act) by the Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014 - external site commenced on 28 February 2014.

The amendments make a number of minor but important changes that streamline and improve the operation of the regulatory scheme for industry, consumers, health professionals and the TGA. These changes ensure greater consistency in the regulation of different types of therapeutic goods.

A summary of the 13 main sets of amendments is set out below.

1. Excluding goods from the Therapeutic Goods Act

The Minister for Health is able, by making a determination under new section 7AA of the Act, to exclude goods from regulation under the Act. Before excluding any goods, the Minister will have to consider:

• whether it is likely that the goods might harm the health of members of the public if they were not regulated under the Act
• whether it is appropriate in all circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by the Act to regulate the goods
• whether any risks to which the public might be exposed from the goods could be more appropriately managed under another regulatory scheme.

Any determination by the Minister excluding goods will be preceded by consultation with affected industry and other stakeholders and will be disallowable by the Parliament.

2. Removing products from the Australia Register of Therapeutic Goods that are not 'therapeutic goods'

The Secretary of the Department of Health^[1] will, under a new section 9F of the Act, be able to remove a product from the Australian Register of Therapeutic Goods (ARTG) if satisfied that the goods are not 'therapeutic goods' as defined in the Act.

The TGA will inform the sponsor of the product and consider any submissions made by the sponsor before the product is removed from the ARTG. Particulars of a decision to remove will be published on this website or in the Commonwealth Government Notices Gazette - external site (the Gazette). It is not an offence under the Act to import, manufacture or export products that are not therapeutic goods.

This power is different from the TGA's power to cancel a product from the ARTG where, for instance, it does not comply with regulatory requirements. Such a product remains therapeutic goods and if it is cancelled on the basis of non-compliance, it is an offence under the Act to import, manufacture or export the product, unless it is otherwise exempt.

¹ Officers of the TGA exercise the powers of the Secretary under the Act as her delegate. The references in this material to 'the TGA' are to the Secretary and her delegates.

3. Giving false or misleading information to the TGA

It is an offence under the Act and civil penalties may apply where a person gives the TGA false or misleading information as part of an application for approval to supply therapeutic goods. The amendments create a new offence and provide for civil penalties where a person gives false or misleading information to the TGA when seeking approval under section 9D of the Act to make changes to goods that have already been approved and are on the ARTG.

It is an offence and civil penalties may apply if the sponsor of a complementary medicine gives false or misleading information in response to a notice from the TGA to provide information. Amendments extend the offence and civil penalties to sponsors of other listed goods and registered therapeutic goods. Similar offence and civil penalty provisions already apply to the sponsors of biologicals and medical devices.

4. New powers of cancellation in relation to the presentation of listed and registered therapeutic goods

The 'presentation' of therapeutic goods means the way in which the goods are presented for supply and includes matters relating to the name, labelling and packaging and any advertising or other informational material associated with the goods.

The presentation of therapeutic goods must be either 'acceptable' (in the case of registered goods) or 'not unacceptable' (in the case of listed goods) to be approved for supply. The Act contains in subsection 3(5) a description of the circumstances in which the presentation of therapeutic goods will be taken to be 'unacceptable'.

To ensure that registered and listed goods continue to satisfy these requirements for so long as they remain entered on the ARTG, the TGA will have power under section 30 of the Act to cancel the registration or listing of therapeutic goods if it appears that:

• the presentation of listed therapeutic goods is unacceptable; or
• the presentation of registered therapeutic goods is not acceptable.

The TGA will also have the power under section 30 of the Act to cancel the registration or listing of therapeutic goods if the sponsor fails to respond to a notice to provide information or documents within 14 days after the period specified in the notice. The TGA already has this power in relation to complementary medicines, biologicals and medical devices.

5. Commencement of conditions

Currently most goods on the ARTG are subject to certain conditions. Changes in relation to these conditions can only come into effect after 20 working days or 28 days after notice has been given by the TGA. This limitation does not apply if the action is necessary to prevent imminent risk of death or serious illness or serious injury.

Under the amendments it is now possible for the imposition, variation or revocation, of conditions to come into effect at an earlier time, but only if the sponsor agrees.

The same will apply to conditions on manufacturing licences and conformity assessment certificates.

6. Publication of information about regulatory decisions

Prior to these amendments the TGA was required to publish information about various kinds of regulatory decisions in the Gazette. The amendments extend the requirements to cover decisions to cancel listed and registered therapeutic goods (including prescription, over-the-counter and complementary medicines).

The amendments also give the TGA the option of publishing information about regulatory decisions on this website rather than in the Gazette.

The TGA has started publishing information about decisions to cancel therapeutic goods from the ARTG on the TGA website.

7. Notification of selection for audit of some applications for inclusion on the ARTG

The period within which the TGA has to inform the applicant for the inclusion of a medical device in the ARTG that its application has been selected for audit by the TGA is 20 working days. Under regulations made under the amendments, the TGA will have a longer period to consider any application by a sponsor of a Class IIb hip, knee and shoulder joint implantable medical device (that was on the ARTG on 1 July 2012) to up-classify the device to Class III, provided the application is made by the end of the reclassification transition period (30 June 2014).

8. Making consistent the revocation of sponsor-initiated cancellations

Any sponsor can request the TGA to cancel its products from the ARTG. Holders of manufacturing licences and conformity assessment certificates can also make a request for their licences/certificates to be cancelled by the TGA.

Sponsors of listed and registered therapeutic goods can request that the TGA revoke such a cancellation provided they do so within 90 days and pay any applicable fee. Once revoked, the cancellation is taken never to have occurred. The amendments make the same provision for sponsors of biologicals and medical devices and holders of manufacturing licences and conformity assessment certificates.

9. Definition of 'kit'

The definition of 'kit' in section 7B of the Act is amended to cover kits containing (among other things) only one registered or listed therapeutic good, or a biological, rather than the current requirement for a kit to consist of a minimum of two separate therapeutic goods.

10. Right of review in relation to conditions imposed on section 14 and 14A exemptions

Under sections 14 and 14A of the Act, the TGA can consent to sponsors of therapeutic goods (other than medical devices) not complying with a standard that would otherwise be applicable to the goods. The consent can be made subject to conditions imposed under section 15 of the Act.

The amendments will allow a sponsor to seek internal and Administrative Appeal Tribunal (AAT) review of a decision of the TGA to impose a condition on such a consent. The consent decision itself is already subject to internal and AAT review.

Internal and AAT review is already available in relation to the imposition of conditions on an exemption from compliance with the essential principles for medical devices.

11. Technical amendments to the Act in relation to evaluation and registration of therapeutic goods

Technical amendments have been made to section 25 of the Act (under which decisions to register therapeutic goods are made) and section 25AA of the Act (under which decisions to approve Product Information (PI) for some registered medicines are made).

These changes make no difference in practice to how decisions will be made under the Act in relation to the registration of therapeutic goods or to the approval of PI for registered medicines.

• The decision to register or to refuse registration is now made under subsection 25(3).
• Notification of a decision to register is now made under section 25AB.
• Notification of a decision to refuse registration is now made under section 25AC.
• The decision to approve PI continues to be made under section 25AA.

The changes also clarify the requirements of the decision-maker to approve PI only if satisfied that the PI reflects the basis on which the decision to register the medicine was made.

12. Requesting information about registered goods

The power of the TGA to request information from applicants for registration, or sponsors or former sponsors of registered goods now includes the power to ask for information or documents about the conformity of the goods with any applicable standards. This power already exists in relation to listed goods.

13. Advertising - references to the Therapeutic Goods Advertising Code

Therapeutic goods must comply with advertising requirements in order to be entered and to remain on the ARTG. To avoid any doubt, provisions in the Act referring to advertising requirements now also refer specifically to the Therapeutic Goods Advertising Code made under the Act.