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

Therapeutic Goods (Provisional and Priority Determinations and Orphan Drug Designations) 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 22C of the Therapeutic Goods Act 1989 and regulations 16H and 16Q 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 and Priority Determinations and Orphan Drug Designations) Approval of Application Form.

2. Definitions

In this instrument:

Act means the Therapeutic Goods Act 1989.

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.

therapeutic goods (priority applicant) determination has the meaning given by section 25AAA of the Act.

3. Applications to which this instrument applies

This instrument applies to the following applications:

1. an application under subsection 22C f the Act for a provisional determination;
2. an application under regulation 16H of the Regulations for an orphan drug designation;
3. an application under regulation 16Q of the Regulations for a therapeutic goods (priority applicant) determination.

4. Approved form

The approved form for an application to which this instrument applies is the online form titled Prescription Medicines Designation/Determination 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 on the TGA Business Services website.