Variation of entries in Register—biologicals
10AAD Variation of entries in Register—biologicals
Kinds of variations
For the purposes of paragraph 9D(3AC)(b) of the Act, a variation:
of an entry in the Register that relates to a biological; and
that is listed in the table in subregulation (2);
is specified.
Conditions
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:
the variation reflects a change that will be made to, or in relation to, the biological;
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 |
This Act’s bill:Explanatory statement
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