Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form

Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form

I, Adrian Bootes, Assistant Secretary, Prescription Medicines Authorisation Branch, a delegate of the Secretary of the Department of Health for the purposes of section 22E of the Therapeutic Goods Act 1989 and regulation 16L of the Therapeutic Goods Regulations 1990, make the following instrument.

Adrian Bootes
Delegate of the Secretary

4 April 2018

1. Name

This instrument is the Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form.

2. Definitions

In this instrument:

Act means the Therapeutic Goods Act 1989.

initial period has the meaning given by subsection 22E(2) of the Act.

orphan drug designation means a designation under regulation 16J of the Regulations.

provisional determination means a determination under section 22D of the Act.

Regulations means the Therapeutic Goods Regulations 1990.

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

3. Applications to which this instrument applies

This instrument applies to the following applications:

1. an application under subsection 22E(3) of the Act for an extension of the initial period of a provisional determination;
2. an application under regulation I 6L of the Regulations for an extension of an orphan drug designation.

4. Approved form

The approved form for an application to which this instrument applies is the online form titled Prescription Medicines - Designation/Determination Extension Application in the TGA's electronic lodgement facility, completed in accordance with the relevant instructions in that form.

Note: The TGA's electronic lodgement facility is o