Therapeutic Goods (Biologicals—Information that Must Accompany Application for Inclusion in Register) Determination July 2018

I, Jane Cook, a delegate of the Secretary of the Department of Health for the purposes of section 32DDA of the Therapeutic Goods Act 1989, make the following Determination under subsections 32DDA(9) and (10) of that Act.

Dated 27 July 2018

(Signed by)

1  Name

  This instrument is the Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018.

2  Commencement

  This instrument commences on the day after it is registered.

3  Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

4  Definitions

  In this instrument:

Act means the Therapeutic Goods Act 1989.

Class 2 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.

Class 3 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.

Class 4 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.

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

5  Applications to which this instrument applies

  This instrument applies to an application under section 32DD of the Act to include a Class 2 biological, Class 3 biological or Class 4 biological in the Australian Register of Therapeutic Goods.

6  Kind of information

  For the purposes of subsection 32DDA(9) of the Act, an application relating to a Class 2,3 or 4 biological must be accompanied by the information required by the Technical Requirements section of the document titled Dossier requirements for Class 2, 3 and 4 biologicals, Australian Regulatory Guidelines for Biologicals (ARGB) version 1.0, published by the TGA in July 2018.

Note: The document mentioned in section 6 is available on the TGA website (www.tga.gov.au).

7  Form of information

  For the purposes of subsection 32DDA (10) of the Act, the information must be:

 (a) contained in an application dossier; and

 (b) in a form consistent with the document titled General dossier requirements, version 1.4, published by the TGA in July 2018.

Note: The document mentioned in paragraph 7(b) is available on the TGA website (www.tga.gov.au).

Schedule 1—Repeals

Therapeutic Goods (Biologicals–Information that Must Accompany Application for Inclusion in Register) Determination 2018

1  The whole of the instrument

Repeal the instrument.