Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 10AAB

Variation of entries in Register--prescription medicines other than biological medicines

Kinds of variations

             (1)  For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.

Conditions

             (2)  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:

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

                     (b)  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--prescription medicines other than biological medicines

Column 1

Column 2

Column 3

Item

Variation

Code

1

A change to the container or closure system used to store a non-sterile active pharmaceutical ingredient of the medicine

ACCS

2

A change to the synthesis of an active pharmaceutical ingredient of the medicine if:

(a) the ingredient is not a synthetic polypeptide; and

(b) the ingredient is not prepared by fermentation; and

(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and

(d) the Directorate:

(i) has issued a revised certificate of suitability in relation to the ingredient; or

(ii) has declared that the ingredient does not require a revised certificate of suitability

ACEP

3

A change to the size of a manufacturing batch of a non-sterile active pharmaceutical ingredient, or a non-sterile intermediate of such an ingredient, of the medicine

AMBS

4

The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site

AMCS

5

The introduction, revision or discontinuation of:

(a) an in-process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or

(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate

AMIT

7

If an active pharmaceutical ingredient of the medicine is manufactured by multi-step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):

(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or

(b) the manufacture of such an intermediate at an additional site

AMMF

8

The transfer of the manufacture of a non-sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:

(a) the ingredient is not prepared by fermentation; and

(b) the ingredient is a pure chemical entity; and

(c) the ingredient is prepared:

(i) by chemical synthesis; or

(ii) through isolation from a natural source

AMTA

9

A change to a non-biological method used for assaying or residual solvent testing (including testing for water) any of the following:

(a) an active pharmaceutical ingredient of the medicine;

(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;

(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient

ASAM

10

Either of the following:

(a) a shortening of the re-test period for an active pharmaceutical ingredient of the medicine;

(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine

ASDR

11

A change to an identification test used in relation to:

(a) an active pharmaceutical ingredient of the medicine; or

(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or

(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient

ASID

12

A change to the specifications for:

(a) an active pharmaceutical ingredient of the medicine; or

(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or

(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;

if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent

ASNL

13

A change, resulting from the addition of a new test and its associated limits, to the specifications for:

(a) an active pharmaceutical ingredient of the medicine; or

(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or

(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient

ASNT

14

A change to the specifications for an active pharmaceutical ingredient of 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

ASPT

15

A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form

DMBS

16

A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:

(a) semi-solid or liquid; and

(b) not a modified release dosage form

DMEL

17

A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:

(a) nasal or oral inhalation; and

(b) not a modified release dosage form

DMEO

18

A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:

(a) solid; and

(b) not a modified release dosage form

DMES

19

The introduction, revision or discontinuation of:

(a) an in-process control test applied during the manufacture of the medicine; or

(b) a limit associated with an in-process control test applied during the manufacture of the medicine

DMIT

20

A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form

DMRO

21

A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:

(a) sterile; and

(b) not a modified release dosage form

DMSE

22

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

DMDM

23

Any of the following:

(a) if the dosage form of the medicine is sterile:

(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or

(ii) the performance of those things at an additional site;

(b) if the dosage form of the medicine is not sterile:

(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or

(ii) the performance of those things at an additional site

DMPL

24

If the dosage form of the medicine is:

(a) non-sterile semi-solid or non-sterile liquid; and

(b) not a modified release dosage form;

either of the following:

(c) a change to the location of a site where the medicine is manufactured;

(d) the manufacture of the medicine at an additional site

DMSL

25

If the dosage form of the medicine is:

(a) non-sterile oral, or non-sterile nasal, inhalation; and

(b) not a modified release dosage form;

either of the following:

(c) a change to the location of a site where the medicine is manufactured;

(d) the manufacture of the medicine at an additional site

DMSO

26

If the dosage form of the medicine is:

(a) non-sterile solid; and

(b) not a modified release dosage form;

either of the following:

(c) a change to the location of a site where the medicine is manufactured;

(d) the manufacture of the medicine at an additional site

DMSS

27

Either of the following:

(a) a change to the location of a site where either of the following are performed in relation to the medicine:

(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);

(ii) release for supply;

(b) the performance of either of the following in relation to the medicine at an additional site:

(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);

(ii) release for supply

DMTR

28

A change to a non-biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical

DSAM

29

A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine

DSID

30

A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine

DSIP

31

A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent

DSNL

32

The addition of a new test and limits associated with the test to the specifications for the medicine

DSNT

33

A minor change to a method used to test physiochemical parameters of the medicine

DSPL

34

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

DSPT

35

A change to a method used to test the sterility of the medicine

DSST

36

If:

(a) the medicine is not administered by the parenteral, ophthalmic or intra-tracheal route; and

(b) the source of an excipient in the medicine is Category IC ruminant tissue;

any of the following:

(c) a change in the source of the excipient to a non-animal source;

(d) a change in the manufacturing process of the excipient;

(e) a change to the location of a manufacturing site

EMRS

37

A change to a method used to assay an excipient in the medicine

ESAM

38

A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient

ESIP

39

A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent

ESNL

40

A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine

ESNT

41

A change to the specifications for an excipient in 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

ESPT

42

A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine

CCCA

43

A change to the size or shape of a container or closure system for the medicine if the medicine is non-sterile

CCSS

44

Any of the following changes to the specifications for a container or closure system for the medicine:

(a) the inclusion of a new test;

(b) making a limit more stringent;

(c) the deletion of a test procedure;

(d) a minor change to a test method

CCST

45

If the dosage form of the medicine is non-sterile, and solid or semi-solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine

CMDT

46

An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:

(a) non-sterile; and

(b) solid, semi-solid, semi-liquid or liquid

CMIT

47

A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection 10(1) of the Act that applies to the medicine)

LQAE

48

A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation

LQAT

49

A change to a label for the medicine to include the term "hypotonic", "hypertonic" or "isotonic" if the medicine is a large-volume injection

LQHI

50

A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch

LQRT

51

A change to a label for the medicine to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous

LWAH

52

A change to a label for the medicine to include a warning or cautionary statement if:

(a) the Secretary, under subsection 9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and

(b) the Secretary, under subsection 25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection 25AA(1) of the Act to add that warning or cautionary statement

LWSR

53

A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine

ASPC

54

A minor change to:

(a) the manufacture of an active pharmaceutical ingredient of the medicine; or

(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or

(c) an intermediate of an active pharmaceutical ingredient of the medicine;

if the change does not affect any step taken to sterilise the ingredient or intermediate

AMMC

55

A change to a label for the medicine that deletes text from side or rear panels 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

56

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

57

A change to a label for the medicine to include, remove or change the sponsor's or distributor's logo or livery

LPCL

58

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

59

A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form

LPCP

60

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

61

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

62

A change to a label for the medicine as a consequence of:

(a) a variation, under subsection 9D(3) of the Act, of the entry in the Register that relates to the medicine; or

(b) a condition imposed, under subsection 28(3) of the Act, on the listing or registration of the medicine

LOCI

63

A change to a label for the medicine that removes phrases indicating novelty, such as "New formulation" or "New appearance"

LPRP

64

A change to a label for the medicine to include a QR code, if the link is:

(a) to a website owned by the person in relation to whom the medicine is included in the Register; and

(b) to information that is non-promotional

LPQR

65

A change to a label for the medicine to include information about a patient support program

LPPS



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