Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

I, Larry Kelly, Acting Deputy Secretary, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23C of the Therapeutic Goods Act 1989, make the following instrument under paragraphs 23C(2)(a) and (b) of that Act.

Dated: 29 March 2018

Larry Kelly
Delegate of the Secretary of the Department of Health

1. Name

This instrument is the Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered.

2. Definitions

In this instrument:

Act means the Therapeutic Goods Act 1989.

code stock means an existing medicine that is made available for use as by one or more sponsors under their own brand name.

medicine kit means a kit within the meaning of subsection 7B(l) of the Act.

TGA means the part of the Department of Health known as the Therapeutic Goods Administration.

Note: Composite pack is defined in subsection 3(1) of the Act as having the meaning given by subsection 7B(2) of the Act.

3. Applications to which this instrument applies

This instrument applies to an application to list a medicine under section 26 or 26A of the Act.

4. Form of application

1. The approved form for an application to which this instrument applies, other than an application mentioned in subsection (2), (3), (4) or (5), is as follows:
   1. if the listing is for export only-the online form titled Export Only General Application in the TGA's electronic lodgement facility;
   2. in any other case-the online form titled General Listing Application in the TGA's electronic lodgement facility.
2. The approved form for an application relating to a composite pack is as follows:
   1. if the listing is for export only- the online form titled Export Only Composite Pack Application in the TGA's electronic lodgement facility;
   2. in any other case-the on line form titled Composite Pack Listing Application in the TGA's electronic lodgement facility.
3. The approved form for an application relating to a medicine kit is the online form titled Medicine Kit Listing Application in the TGA's electronic lodgement facility.
4. The approved form for an application relating to a medicine prepared from code stock is the online form titled Medicine preparedfiwn a code stock in the TGA's electronic lodgement facility
5. The approved form for an application relating to changes to multiple current listings is as follows:
   1. if the current listings are for export only-the online form titled Variation Change Multiple Listings Application in the TGA's electronic lodgement facility;
   2. in any other case-the online form titled Change Multiple Listings Application in the TGA's electronic lodgement facility.

Note: The TGA's electronic lodgement facility is on the TGA Business Services website (https://adfs.tga.gov.au/).

5. Office to which application must be delivered

An application must be delivered to the office of the TGA, using the TGA's electronic lodgement facility.