Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012
Therapeutic Goods Act 1989
I, JOHN SKERRITT a delegate of the Minister for Health, make this Specification under subsection 61(5D) of the Therapeutic Goods Act 1989.
Dated 12 October 2012
(signed by)
JOHN SKERRITT
Delegate of the Minister for Health
1 Name of Specification
This Specification is the Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012.
2 Commencement
This Specification commences on the day after it is registered.
3 Definitions
In this Specification:
Act means the Therapeutic Goods Act 1989.
Compliance review in relation to a listed complementary medicine means a review undertaken by the TGA to assess the compliance of a listed complementary medicine against the legislative requirements in the Act that apply to such a medicine, and which involves:
· assessing information about the medicine against those legislative requirements, including, for example, verifying the correctness of the certifications made by the sponsor at the time the medicine was listed on the Register.
Listed complementary medicine for the purpose of this Specification, means a medicine (other than a sunscreen) that is, or that was at the time of a compliance review, listed on the Register under section 26A of the Act.
Register means the Australian Register of Therapeutic Goods.
TGA means the Therapeutic Goods Administration.
4 Therapeutic goods information, persons and purposes
The kinds of therapeutic goods information mentioned in Schedule 1 are specified for the purposes of subsection 61(5D) 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.
1 Details of listed complementary medicines that have undergone a compliance review, and the outcomes of those reviews
(a) The information listed below that relates to a listed complementary medicine that has been reviewed as part of a completed compliance review, and the outcome of that review:
(i) the listing number of the medicine;
(ii) the name of the medicine;
(iii) the sponsor of the medicine;
(iv) the date that the compliance review was completed by the TGA in relation to the medicine; and
(v) whether or not, following the completion of the compliance review, the medicine remained listed on the Register or was cancelled from the Register by the Secretary.
2 Details relating to the cancellation of listed complementary medicines from the Register following the completion of a compliance review
(a) The information listed below that relates to a listed complementary medicine cancelled from the Register by the Secretary following the completion of a compliance review of that medicine:
(i) the listing number of the medicine;
(ii) the name of the medicine;
(iii) the sponsor of the medicine;
(iv) the date that the compliance review was completed by the TGA in relation to the medicine;
(v) the date that the medicine ceased to be listed on the Register under subsection 30(5) of the Act following the cancellation of the medicine by the Secretary; and
(vi) the provision or provisions in section 30 of the Act under which the medicine was cancelled by the Secretary, and (except where the medicine was cancelled as a result of a request by the medicine’s sponsor) a summary of the reasons for which the medicine was cancelled under that provision or those provisions.
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au
