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