Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016 (Cth)

Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016 Therapeutic Goods Act 1989

I, Larry Kelly, a delegate of the Minister for Health, make this Specification under subsection 61(5D) of the Therapeutic Goods Act 1989.

Dated 4 May 2016

(Signed by)

LARRY KELLY Delegate of the Minister for Health

1 Name of Specification This Specification is the Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016. 2 Commencement This Specification commences on 1 July 2016. 3 Definitions In this Specification:

Act means the Therapeutic Goods Act 1989.

Annual Charges Exemption Scheme means the scheme relating to exemptions from liability to pay annual charges set out in Subdivision 2 of Division 1 of Part 7 of the Regulations.

ARTG means the Australian Register of Therapeutic Goods.

Regulations means the Therapeutic Goods Regulations 1990.

Sponsor means the person in relation to whom therapeutic goods are registered, listed or included in the ARTG.

4 Therapeutic goods information The kinds of therapeutic goods information mentioned in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.

Schedule 1 Specified kinds of therapeutic goods information (section 4)

The following kinds of therapeutic goods information:

Note: The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act.

Kinds of therapeutic goods information relating to exemptions under the Annual Charges Exemption Scheme

Item Information Description

(a) Sponsor name The name of the sponsor in relation to whom therapeutic goods were registered, listed or included in the ARTG in a particular financial year and who was exempt from paying an annual charge in relation to those goods in that financial year.