Variation of entries in Register—biological medicines
10AAC Variation of entries in Register—biological medicines
Kinds of variations
For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.
Conditions
For the purposes of paragraph 9D(2C)(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 2 of an item in the following table:
the variation reflects a change that will be made to, or in relation to, the medicine;
the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.
Kinds of variations—biological medicines | ||
|---|---|---|
Column 1 | Column 2 | Column 3 |
Item | Variation | Code |
1 | A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent | PSNL |
2 | A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine | PSQC |
3 | The release for supply of the medicine at an additional site | PMRS |
4 | A reduction in the column life of columns used in the purification process for the medicine | PPCR |
5 | A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma‑derived | PPHR |
6 | A change to the manufacturer of a filter used in a fermentation process for the medicine | FPFM |
7 | The introduction of more stringent internal controls on a fermentation process for the medicine | FPNC |
8 | A reduction in the time required to culture and harvest the cell line for the medicine | FPRP |
9 | A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine | PFCR |
10 | The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine | PFSC |
11 | A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent | ISNL |
12 | A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the drug substance or excipient; or (b) an order in force under subsection 10(1) of the Act that applies to the drug substance or excipient | ISPT |
13 | A change to a method used for testing a drug substance or excipient of the medicine if: (a) the change is to adopt a method in a default standard; and (b) the test is not for viral safety | ISAM |
14 | A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard | PSNT |
15 | A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | PSPT |
16 | A minor change to a physicochemical test method used for testing the medicine | PMPL |
17 | The replacement of an in‑house reference standard with another if the protocol and acceptance criteria for establishing a replacement in‑house reference standard have been approved by the Therapeutic Goods Administration | IRSR |
18 | A change to a label for the medicine that deletes text from a side or rear panel if: (a) the text is present elsewhere on the label for the medicine; and (b) repetition of the information on the panel is not required by an order in force under subsection 10(1) of the Act, or a condition imposed by or under section 28 of the Act, that applies to the medicine | LPDR |
19 | A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine | LPCS |
20 | A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery | LPCL |
21 | A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form | LPDG |
22 | A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form | LPCP |
23 | A change to a label for the medicine to include: (a) simple instructions or information relating to the packaging of the medicine; or (b) information describing a change in appearance of the dosage form | LPIA |
24 | A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine | LPOP |
25 | A reduction in the shelf life of the drug substance of the medicine | ASRS |
26 | A reduction in the shelf life of the medicine | PSLD |
27 | The introduction of anti‑tamper packaging if the packaging material is not in contact with the medicine | PPAT |
28 | Either or both of the following changes to the manufacture of the medicine: (a) removal of a temperature excursion; (b) reduction in the time spent out of refrigeration or freezer storage | PSET |
29 | The addition of a storage condition for the medicine | PSAR |
30 | A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed | OAMS |
This Act’s bill:Explanatory statement
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