Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 10AAD

Variation of entries in Register--biologicals

Kinds of variations

  (1)   For the purposes of paragraph   9D(3AC)(b) of the Act, a variation:

  (a)   of an entry in the Register that relates to a biological; and

  (b)   that is listed in the table in subregulation   (2);

is specified.

Conditions

  (2)   For the purposes of paragraph   9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:

  (a)   the variation reflects a change that will be made to, or in relation to, the biological;

  (b)   the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.

 

Kinds of variations--biologicals

Item

Column 1

Variation

Column 2

Code

1

A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:

(a) a default standard that applies to the biological; or

(b) an order in force under subsection   10(1) of the Act that applies to the biological

PT

2

A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent

DS

3

A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit's ability to detect an infectious disease

TK

4

A change to a critical material used in the manufacture of the biological if:

(a) the critical parameters for the changed material are equivalent or of greater quality; and

(b) the material is not of human or animal origin; and

(c) the material is not an excipient; and

(d) in the case of critical material that is a container for the biological--the change is not a change to the composition of the material

SM

5

The introduction of more stringent limits to an in - process control test applied during the manufacture of the biological

MI

6

The removal of a product if the biological is a Class 2 biological

BR

7

The addition of a site at which secondary packaging or storage of the biological is performed

MA

8

A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:

(a) quality control testing;

(b) infectious disease testing

MT

9

The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site

MR

10

The introduction of more stringent limits to a release test applied during the manufacture of the biological

BS

11

A reduction in the shelf life or shipping timeframe of the biological

BT

12

A change to the label or supporting documentation for the biological to:

(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or

(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient

LC

13

For an export only biological, a change to information included in the entry in the Register for the export only biological

EX



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