Therapeutic Goods (Biologicals-Application Form for Priority Applicant Determinations) Approval 2022

I, Andrew Wagner, as delegate of the Secretary of the Department of Health and Aged Care, make the following approval.

Date 7 December 2022

Andrew Wagner
Acting Director, Biological Science Section
Scientific Evaluation Branch
Medicines Regulation Division
Health Products Regulation Group
Department of Health and Aged Care

1  Name

 This instrument is the Therapeutic Goods (Biologicals—Application Form for Priority Applicant Determinations) Approval 2022.

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note:   This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

This instrument is made under regulation 16V of the Therapeutic Goods Regulations 1990.

4  Definitions

Note 1:  A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a)   biological;

(b)   Secretary.

Note 2:   A number of expressions used in this instrument are defined in regulation 2 of the Regulations, including the following:

(a)   biologicals (priority applicant) determination;

(b)   Therapeutic Goods Administration.

In this instrument:

Act means the Therapeutic Goods Act 1989.

Regulations means the Therapeutic Goods Regulations 1990.

5  Approved form

The approved form for an application to the Secretary under subregulation 16V(1) of the Regulations for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological, is the application form titled Application for a biologicals (priority applicant) determination published on the Therapeutic Goods Administration website.