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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.

(b)    ARTG number                                                    The ARTG number of the therapeutic goods in relation to which the exemption applied.

(c)    Name of the therapeutic goods                                  The name of the therapeutic goods as it appeared in the relevant ARTG entry in relation to which the sponsor was exempt from paying an annual charge in the relevant financial year.

(d)    Exemption from annual charges for a particular financial year  That the sponsor was, for a particular financial year, exempt under the Annual Charges Exemption Scheme from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the ARTG, in respect of therapeutic goods as identified by name and ARTG number.

Kinds of therapeutic goods information relating to exemptions found not to apply 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 relation to a particular financial year, and who:
                                                                             * declared,