Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsKinds 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.
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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 |