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ARGCM Part D: Registered complementary medicines

4 December 2017

These changes tables are for registered complementary medicines.

More information is available on:

  1. Status codes
  2. Assurance codes
  3. Application level

'The Act' referred to in the tables is the Therapeutic Goods Act 1989.

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Labelling (including package insert) and product detail changess
Change codes Labelling (including package insert) and product detail changes Status codes Assurance codes Application level Applicable section of the Act
GPN

Proprietary name (if grouping applies) where either:

A 1, 2 C2 23
GPU

Proprietary name (if grouping applies) where:

  • the product name includes an umbrella branded name and the umbrella segment is categorised as requiring a higher level of assessment and/or
  • the product name has been amended to include a new 'fast acting' claim e.g. 'Farracet Rapid Tablets' on the basis of Module 5 data
A 1, 2 C3 23
  Proprietary name (if grouping doesn't apply) NEW      
GIN New therapeutic indications (if grouping applies) where there is no requirement for supporting Module 4 and/or Module 5 data A 1, 3 C2 23
GID New therapeutic indications (if grouping applies) where supporting Module 4 and/or Module 5 data or a justification for not providing the supporting data is required A 1, 3 C4 23
  New therapeutic indications (if grouping doesn't apply) NEW      
LIW Therapeutic indications or directions for use - change of wording without altering meaning A 4, 5 C2 9D(3)
LIS Therapeutic indications - removal of sub-set of indications from label SRR 5 C1 9D(2)
LIR Therapeutic indications - addition of registered indications to label A 5 C2 9D(3)
GDS

Directions for use - involves a reduction in the class of person for whom the goods are suitable

e.g. changing a statement from 'not recommended for children under 12 years' to 'not recommended for children or adolescents under 18 years'

SRR 5 C1 9D(2)
GDU Directions for use - changes to the dosage instructions (if grouping applies), other than changes described in GDS or LIW, where there is no requirement for supporting Module 4 and/or Module 5 data A 1, 3 C2 23
GDD Directions for use - changes to the dosage instructions (if grouping applies), where supporting Module 4 and/or Module 5 data or a justification for not providing the supporting data is required A 1, 3 C4 23
  Directions for use (if grouping doesn't apply) NEW      
PSC Recommended storage conditions - more restrictive N 5 CN 9D(2C)
PST Recommended storage conditions - less restrictive A 5 C2 9D(3)
LSR

Addition of more restrictive safety-related statements including:

  • reduction in the class of person for whom the goods are suitable, e.g. changing a statement from 'not recommended for children under 12 years' to 'not recommended for children or adolescents under 18 years'
  • addition of a warning or precaution including a new RASML statement
SRR 5 C1 9D(2)
LSF Changes on label (signal headings, warning statements) in compliance with new SUSMP (Poisons Standard) requirements, where the change in scheduling is to a lower SUSMP schedule, except where LSC applies A 5, 8 C2 9D(3)
LSC Changes on label (signal headings, warning statements) in compliance with new SUSMP (Poisons Standard) requirements, where the change in scheduling is to a lower SUSMP schedule where no such products have previously been approved as a complementary medicine A 5, 8 C3 9D(3)
LSU Changes on label (signal headings, warning statements) in compliance with new SUSMP (Poisons Standard) requirements, other than LSF or LSC SRR / SAR 5, 8 C1 9D(2) / 9D(3)
LNT Changes to bring a label into full compliance with the Therapeutic Goods Order No. 92 - other than changes to the proprietary name. If changing proprietary name (and where grouping applies), also use code GPN or GPU A 5 C2 9D(3)
LLR Addition of a required representation to a label (Part 2 of Schedule 2 to the Therapeutic Goods Regulations 1990) SRR 5, 7 C1 9D(2)
LCF Colour or type size change only (no change in label copy) other than where LFT applies SAR 5 C1 9D(3)
LFT Font or type size other than change to the type size on the main panel of the label. Does not include change in colour or label copy. N 5 CN 9D(2C)
LGR Introduction of new graphics/icons (other than as specified in change LSP & KSP) A 5 C2 9D(3)
RGR Removal of a graphic (other than as specified in change LAB for removal of sponsor logo or RGN) SAR 5 C1 9D(3)
RGN Removal of a graphic except where this relates to directions on how to use the product or the use of a measuring device or an applicator (see KMD and KMO) N 5 CN 9D(2C)
LFO Reformatting of pre-existing text (i.e.. moving or duplication of blocks of text and not rewording - see LIW, LDT, LDD) and/or movement of graphics (other than specified in LGM) SAR 5 C1 9D(3)
LGM Movement of graphics provided it remains on the same panel of the label and there is no change to the size, shape or colour of the graphic and does not involve the reformatting of pre-existing text. N 5 CN 9D(2C)
LLN Introduction of a 'new' or a 'value pack' flash - see LAB for removal of a 'new' or a 'value pack' flash N 5 CN 9D(2C)
LSS Introduction of text and / or graphics pertaining to sponsorship of a campaign or organisation, e.g. the Cancer Council's Pink Ribbon campaign or Surf Life Saving Australia A 5 C1 9D(3)
LDT Deletion or addition of text to the label (e.g. addition or removal of claims such as clinically proven, fast/rapid action; general claims regarding the product, its nature, mechanism of action, qualifying statements etc.) A 5 C2 9D(3)
LDD Deletion or addition of text to the label where supporting Module 4 and/or Module 5 data or a justification for not providing the supporting data is required. For example, including a 'fast absorption' claim on the label on the basis of new clinical data A 5 C3 9D(3)
KPI Introduction of a package insert where there is no requirement for supporting Module 4 and/or Module 5 data. For example, including a CMI as a pack insert where the CMI is consistent with the product's approved product information A 5, 29 C2 9D(3)
KRI Removal of a package insert (other than CMI) A 5, 30 C2 9D(3)
LSP Changes to sponsor details including name and/or logo (inclusion of a logo or change to an existing logo) except where LAB applies N 5 CN 9D(2C)
LAB

Minor label editorials that have no regulatory compliance impact (under the Therapeutic Goods Act 1989). The changes are limited to the following:

  • correction of misspelt words and/or deletion of a duplicated word - this does not involve rewording or the deletion of sentences or phrases
  • removal of a 'new', 'new formulation' or a 'value pack' flash
  • removal of details of sponsorship (in its entirety) of a campaign or organisation, e.g. the Cancer Council's Pink Ribbon campaign or Surf Life Saving Australia
  • deletion of sponsor logo provided the name and address of the sponsor or supplier of the goods are included on the label
  • inclusion, removal or changes to:
    • country of origin statement (e.g. 'Made in XX') including the statement 'Made in Australia' or 'Australian Made' or the Australian Made logo (gold kangaroo in a green triangle) in accordance with the requirements outlined by the Australian Made Company (refer www.australianmade.com.au)
    • sponsor address and/or contact details provided the information is consistent with the current approved product details and where the name and address of the sponsor or supplier of the goods are included on the label
    • supplier or manufacturer's name, address and/or contact details provided the name and address of the sponsor or supplier of the goods is included on the label
    • date of manufacture of a product
    • website, QR code and/or bar code: applies only where the information included on the website (including any direct links from that website) or incorporated into the QR code or bar code (if either links to a website then any direct links from that website) is consistent with the information approved by TGA for that product
    • ABN / ACN
    • product code number (or equivalent) or an overseas registration number
    • recycle logo and associated text
    • tamper evident seal - wording / graphics. See also KSL and KSX
    • trade mark (™) or registration (®) symbols or similar, or trademark statements e.g. Company XXY is a registered trademark of Company XXZ
  • introduction, deletion or change of a graphic and/or text providing instruction on opening or closing a container
  • anti-theft device (including directly associated wording) that does not impact on or affect the readability of other label wording
O - - -
PSZ Addition of a pack size for dosage forms- other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) or as described in PSN SAR 5, 6, 10 C1 9D(3)
PSN Addition of a pack size for dosage forms other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) where the new pack size falls within the approved pack size range. See also PSZ. N 5, 6, 10 CN 9D(2C)
PLS Addition of pack size - for liquids/semi-solids other than as described in PLN SAR 5, 6, 10, 13 C1 9D(3)
PLN Addition of pack size for liquids/semi solids where the new pack size falls within the approved pack size range. See also PLS. N 5, 6, 10, 13 CN 9D(2C)
PMZ Addition of pack size - for metered dose aerosols A 5,6 C2 9D(3)
PSD Pack size - deletion N 5 CN 9D(2C)
  Dosage form (as defined in TGA approved terminology for medicines) NEW      
PVI Visual identification (note that novelty shapes, e.g. animal-shaped tablets, are not acceptable) SAR 5, 13, 19, 27 C1 9D(3)
PSL Shelf life - increase A 5 C2 9D(3)
PSR Shelf life - decrease N 5 CN 9D(2C)
PMI Sterility status A 5 C2 9D(3)

For the transfer of a good in the ARTG from one sponsor to another, contact TGA Business Services help desk or see Notification of a change of sponsorship.

For changes to sponsor details on the labelling see changes LAB and LSP; for changes to sponsor details in the Product Information (PI) see changes DAB and DAC.

Formulation changes - active ingredientss
Change codes Formulation changes - active ingredients Status codes Assurance codes Application level Applicable section of the Act
  Addition of active ingredient NEW      
  Deletion of active ingredient NEW      
  Amount of an active ingredient - See also Overages and batch to batch variation section of the ARGCM NEW      
  Changes to herbal extracts outside the permitted variations as described within the Guidance on equivalence of herbal extracts in complementary medicines NEW      
AOV Overage - decrease or removal N 5 CN 9D(2C)
AOA Overage - increase A 5 C2 9D(3)
GPA Replacement of a proprietary ingredient which contains an active substance with another proprietary ingredient where the only difference between the two proprietary ingredients (other than name) is to the amount of an excipient(s) ingredient (if grouping applies) A 1, 5 C2 23
  Replacement of a proprietary ingredient which contains an active ingredient with another proprietary ingredient, other than as above in change GPA NEW      
Formulation changes - excipient ingredients
Change codes Formulation changes - excipient ingredients Status codes Assurance codes Application level Applicable section of the Act
ERT

Removal of a fragrance, flavour, printing ink and/or colouring agent(s) if the total agent(s) are present at not more than 2% w/w or w/v (if grouping applies)

Note: this change may result in consequential changes to labelling (including the PI/CMI) and/or specifications (e.g. deletion from the label of declared ingredients or change to visual identification) which should also be addressed in accordance with the changes table.

SAR 1, 5, 13 C1 23
GPI Removal and/or addition of a fragrance, flavour, printing ink and/or colouring agent(s) (if grouping applies), other than change ERT A 1, 5, 13 C2 23
  Removal or addition of a fragrance, flavour, printing ink or colouring agent (if grouping doesn't apply) NEW      
GPR The replacement of one proprietary excipient ingredient with a different proprietary ingredient where the only difference between the two proprietary ingredients (other than name) is a change to the amount of an inactive component of the proprietary ingredient and/or manufacturing process (if grouping applies) other than ERT or GPI A 1, 5, 13 C2 23
  The replacement of one proprietary ingredient with a different proprietary ingredient other than in changes GPI or GPR NEW      
  Addition or deletion of an excipient other than those above in change GPI NEW      
GEX Amount of excipient (if grouping applies) provided the content of the excipient is not higher than previously approved for the dosage form - See Overages and batch to batch variation in Part D of the ARGC A 1, 5, 13 C2 23
GED Increase in the amount of an excipient (if grouping applies) where the content of the excipient is higher than previously approved for the dosage form - See Overages and batch to batch variation in Part D of the ARGCM A 1, 5, 13 C3 23
  Amount of excipient (if grouping doesn't apply) - See Overages and batch to batch variation in Part D of the ARGCM NEW      
EST Type of starch (no change to quantity) N 5, 12 CN 9D(2C)
Quality control changes - finished medicine specifications
Change codes Quality control changes - finished medicine specifications Status codes Assurance codes Application level Applicable section of the Act
QFX Specification limits or requirements - more restrictive O      
QFE Specification limits or requirements - less restrictive (except where QFA applies); where any supporting data provided consist only of Module 3 (and not Module 4) data A 5, 27 C2 9D(3)
QFF Specification limits or requirements - less restrictive; where supporting Module 4 (nonclinical) data or a justification for not providing the supporting data is required. For example, a sponsor wishes to widen the limits for a related substance from the level normally applied of NMT 1% to NMT 3.5% and justifies the widening of the specification on the basis of a dossier which includes preclinical studies and published toxicology papers A 5, 27 C3 9D(3)
QFT Addition of an extra test O      
QFU Deletion of an existing test where any supporting data provided consists only of Module 3 data A 5, 27 C2 9D(3)
QFD Deletion of an existing test where supporting Module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to delete a particular test for a product that would normally be required but provides supporting data in the form of preclinical studies which support the sponsor's case for removal of the test from the specifications A 5, 27 C3 9D(3)
QFI Frequency of testing - increase O      
QFR Frequency of testing - reduction A 5, 27 C2 9D(3)
QFA Changes to the finished product specifications (test, test methods and limits/requirements) to comply with a standard as defined in the Therapeutic Goods Act 1989 (e.g. the BP or a Therapeutic Goods Order), other than as specified in change MST. No non-pharmacopoeial test or requirements are concurrently deleted from the specification O      
QFB Analytical method (does not include changes to tests and limits and requirements) - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity), other than as specified in change MST O      
QFC Analytical method - other than as specified in change QFA, QFB or MST A 5 C2 9D(3)
QFP

Change from one default standard (as defined in the Therapeutic Goods Act 1989) to another (e.g. BP to USP) or from a 'company' or 'in-house' specification to a pharmacopoeial specification.

This includes deletion of the existing pharmacopoeial tests and limits.

This does not involve deletion of, or a change to, any current additional non-pharmacopoeial specifications, e.g. residual solvents in the finished product or friability

N 5, 27 CN 9D(2C)
Quality control changes - starting material specifications
Change codes Quality control changes - starting material specifications Status codes Assurance codes Application level Applicable section of the Act
QSX Specification limits or requirements - more restrictive O      
QSE Specification limits or requirements - less restrictive (except where QSA applies); where any supporting data provided consist only of Module 3 (and not Module 4) data A 5, 27 C2 9D(3)
QSF Specification limits or requirements - less restrictive; where supporting Module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to widen the limits for a related substance from the level normally applied of NMT 1% to NMT 3.5% and justifies the widening of the specification on the basis of a dossier which includes preclinical studies and published toxicology papers A 5, 27 C3 9D(3)
QST Addition of an extra test O      
QSU Deletion of an existing test where any supporting data provided consist only of Module 3 data A 5, 27 C2 9D(3)
QSD Deletion of an existing test where supporting Module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to delete a particular test for a substance that would normally be required but provides supporting data in the form of preclinical studies which support the sponsor's case for removal of the test from the specifications A 5, 27 C3 9D(3)
QSA Changes to the starting material specifications (test, test methods and limits/requirements) to comply with a standard as defined in the Therapeutic Goods Act 1989 (e.g. the BP or a Therapeutic Goods Order). No non-pharmacopoeial test or requirements are concurrently deleted from the specification, e.g. a specification for particle size distribution O      
QSB Analytical method (does not include changes to test limits and requirements) - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity) O      
QSC Analytical method - other than as specified in change QSA or QSB A 5 C2 9D(3)
QSM Manufacturer of starting material (specifications unchanged) O      
QSS Supplier of starting material O      
QSP

Change from one 'default standard' (as defined in the Therapeutic Goods Act 1989) to another (e.g. BP to USP) or from a 'company' or 'in-house' specification to a pharmacopoeial specification.

This includes deletion of the existing pharmacopoeial tests and limits.

This does not include deletion of, or a change to, any current additional non-pharmacopoeial specifications, e.g. particle size distribution.

N 5 CN 9D(2C)
Packaging changes
Change codes Packaging changes Status codes Assurance codes Application level Applicable section of the Act
  Container type (as defined in TGA approved terminology for medicines) NEW      
KBT

Container material - if the container is a bottle, the goods are a solid dosage form (e.g. tablet) and the change in material is of a type described below:

  • Polystyrene to PVC, polyethylene, polypropylene or glass
  • PVC to polyethylene, polypropylene or glass
  • Polyethylene to glass or polypropylene of density ≥ 0.89
  • From one density of polyethylene to a higher density
  • Any change between glass, polyethylene of density ≥ 0.95, and polypropylene of density ≥ 0.89
N 5, 13, 16 & 25 CN 9D(2C)
KGL Container material - clear to coloured glass O      
KBL

Container material - if the container is a blister pack, the goods are a solid dosage form (e.g. tablet) and the change in material is of a type described below:

  • PVC to PVC/PVDC or to PVC/PCTFE
  • PVC/PVDC to PVC/PCTFE

or the change to the plastic component is to a material with demonstrated lower or equivalent water permeability than the existing material (see for example USP monograph '<671> Containers Permeation')

N 5, 13 & 25 CN 9D(2C)
KCI Container - increase in container wall thickness O      
KCD Container - decrease in container wall thickness, except where KBT, KBL A 5 C2 9D(3)
KOT Container material - other than in changes KBT, KGL, KBL, KCI, KCD A 5 C2 9D(3)
KCL Closure - other than changes in KCM or MDA N 5, 13 CN 9D(2C)
KCM Closure, where the closure also serves as a metering component (other than MDA) A 5 C2 9D(3)
MDA Changes in pump or pump components of meter-dose aerosol (e.g. valve material) A 5 C2 9D(3)
KSL Tamper evident seal - addition (including label notice to alert consumers to presence of seal). See also LAB O      
KSX Tamper evident seal - removal (including removal of label notice re seal). See also LAB O      
KWA Inert wadding material - addition, substitution or removal where stability is not affected by the action O      
KDA Desiccant - inclusion in container A 5 C2 9D(3)
KDX Desiccant - removal from container A 5 C2 9D(3)
KPP

Specifications of primary pack except where the primary pack is also the container

Does not include any other changes to the labelling such as text, graphics, colour, font, etc.

Note: primary pack is defined in subsection 3(1) of the Act as 'primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers'

O      
KSP Introduction of a measuring device (e.g. spoon, cylinder) or applicator (e.g. finger cot). This change can include graphical representation (and associated wording where required) of the device on the label. A copy of current & proposed label must be supplied if the label is changed SAR 5, 24 C1 9D(3)
KMO Removal of a measuring device where other means of accurately measuring the dose are readily available. This change can include the deletion of graphical representation of the device (including associated wording) on the label. Does not include changes to the directions for use or any other changes to labelling such as reformatting. A copy of current & proposed label must be supplied if the label is changed. N 5 CN 9D(2C)
KMD Changes to existing measuring device (e.g. spoon, cylinder) or applicator supplied with the goods or removal of an applicator, where other means of accurately administering the dose are readily available. This change can include changes to the graphical representation (and associated wording where required) of the device on the label. It can also include the addition or deletion of graphical representation (including associated wording) of the device on the label. A copy of current & proposed label must be supplied if the label is changed. SAR 5, 24 C1 9D(3)
KPA

Introduction of a primary pack (no new text or graphics)

Note: primary pack is defined in subsection 3(1) of the Act as 'primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers'

SAR 5, 14 C1 9D(3)
KPX Removal of a primary pack SAR 5, 17 C1 9D(3)
KRP Introduction of a refill pack A 5 C2 9D(3)
KRR Removal of refill pack N 5 CN 9D(2C)
Manufacturing changes - finished products
Change codes Manufacturing changes - finished product Status codes Assurance codes Application level Applicable section of the Act
MMA Addition of a manufacturer (includes site of manufacture), other than for sterile products where MSS or MST applies N 5, 9 CN 9D(2C)
MMD Deletion of a manufacturer (includes site of manufacture) N 5 CN 9D(2C)
AMS Addition of steps of manufacture, other than for sterile products where MSS or MST applies N 5, 9 CN 9D(2C)
MSD Deletion of steps of manufacture N 5 CN 9D(2C)
MPT Manufacturing process: tightening of in-process limits and/or introduction of an additional in-process control O      
MPR Manufacturing process other than for 'higher risk' complementary medicines (see MPH or MPD) or for sterile products (see MSS or MST). See also MPT SAR 5, 13 C1 9D(3)
MPH

Manufacturing process for the following 'higher risk' complementary medicines:

  • microdose products (solid oral dosage forms where the active ingredient is present in an amount of less than 2mg or 2% w/w of the dosage form)
  • products with a sustained release characteristic (not including enteric coated products)
  • metered dose inhalers
  • where the changes to the product have been demonstrated to be equivalent to or superior to the approved manufacturing process
SAR 5, 13 C1 9D(3)
MPD

Manufacturing process for the following 'higher risk' complementary medicines:

  • microdose products (solid oral dosage forms where the active ingredient is present in an amount of less than 2mg or 2% w/w of the dosage form)
  • products with a sustained release characteristic (not including enteric coated products)
  • metered dose inhalers
  • except where MPH applies
A 5, 13 C2 9D(3)
MUP GMP clearance number update only; no other change to the product SAR (fee exempt) 5 C1 9D(3)
MSS

For a sterile product (other than where MST applies):

  • Addition of a manufacturer (includes site of manufacture) involving only one or more of the following steps: release for supply, secondary packaging or testing [chemical and physical or microbial]
  • Addition of steps of manufacture involving only one or more of the following steps: release for supply, secondary packaging or testing [chemical and physical or microbial]
N 5, 9 CN 9D(2C)
MST

For a sterile product:

  • Addition of a manufacturer (includes site of manufacture) other than where MSS applies
  • Addition of steps of manufacture other than where MSS applies
  • Change in the manufacturing process
A 5 C2 9D(3)
Consumer Medicine Information (CMI)s
Change codes Consumer Medicine Information (CMI) Status codes Assurance codes Application level Applicable section of the Act
CPI

Introduction of a CMI for a 'Pharmacist Only Medicine' (Schedule 3) product registered after 4 July 1995 where the CMI complies with Schedule 13 to the Therapeutic Goods Regulations 1990 and is not to be included as a package insert.

Note: Change KPI applies where the CMI is to be included as a package insert.

O      
CPO

Changes to an existing CMI, where the changes are consistent with all previously approved product details and the CMI is not to be included as a package insert.

Note: Refer to Labelling (including package insert) and medicine detail changes on changes to a CMI where the CMI is to be included as a package insert (package inserts are treated as part of the label).

O      
Product Information (PI)s
Change codes Product Information (PI) Status codes Assurance codes Application level Applicable section of the Act
DPI Introduction of Product Information (PI) for an existing product where there is no requirement for supporting Module 4 and/or Module 5 data. For example, where the PI is essentially the same as the PI of the originator medicine A 5 C2 9D(3)
DPD Introduction of Product Information (PI) for an existing product where supporting Module 4 and/or Module 5 data or a justification for not providing the supporting data is required. For example, where the PI includes information on clinical trials and Module 5 data are provided to substantiate the information included in the PI A 5 C3 9D(3)
DAB

Minor editorial changes that have no regulatory compliance impact (under the Therapeutic Goods Act 1989). The changes are limited to the following:

  • correction of misspelt words and/or deletion of a duplicated word - this does not involve rewording or the deletion of sentences or phrases
  • deletion of sponsor logo provided the name and address of the sponsor is included in the PI
  • inclusion, removal or changes to:
    • country of origin statement (e.g. 'Made in XX')
    • sponsor address and/or contact details provided the information is consistent with the current approved product details and where the name and address of the sponsor of the goods is included in the PI
    • supplier/manufacturer name, address and/or contact details
    • ABN / ACN
    • product code number (or equivalent) or an overseas registration number
    • trade mark (™) or registration (®)symbols or similar or trademark statements e.g. Company XXY is a registered trademark of Company XXZ
O      
DAC

Updating the PI to reflect the currently approved product details or changes consequential to other changes made in the same application. Changes are limited to the following:

  • storage conditions
  • sponsor details including sponsor name and/or logo (inclusion of a logo or change of an existing logo) except where DAB applies
  • container or pack size details
  • visual identification
  • dosage form
  • route of administration
  • formulation details
  • poisons schedule
  • proprietary name
  • indications (where the wording is identical to that included on the ARTG or that proposed for the ARTG as part of the same application)

Does not include changes to the directions for use

SAR 5 C1 9D(3)
DRS

Addition of more restrictive safety-related statements including:

  • reduction in the class of person for whom the goods are suitable, e.g. changing a statement from 'not recommended for children under 12 years' to 'not recommended for children or adolescents under 18 years'
  • addition of a warning or precaution including a new RASML statement or new statement required in permitted ingredient determination.

(See also LSR for consequential changes to labelling)

SRR 5 C1 9D(2)
DOT Changes (including addition or deletion of text or the rewording or reformatting of existing text) where there is no requirement for supporting Module 4 and/or Module 5 data, other than as specified in change DAB, DAC or DRS A 5 C2 9D(3)
DOD Changes other than the addition of more restrictive safety-related statements where supporting Module 4 and/or Module 5 data or a justification for not providing the supporting data is required. For example, updating the section on Clinical Trials where the changes made are supported by Module 5 data A 5 C3 9D(3)
DRP Removal of a PI where the PI is not required under section 25AA of the Act A 5 C2 9D(3)
Others
Change codes Other Status codes Assurance codes Application level Applicable section of the Act
CTA Correction of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989. Evidence to support the change is included with the application SAR 5, 21 C1 9D(1)
CAO Correction of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989. An application using this change code must include written advice from the TGA advising the use of this change code for the requested change to the product SAR (fee exempt) 5, 21, 31 C1 9D(1)
OT1 'Other' changes - application level C1. An 'other' code is used only when no other code applies. An application using OT1 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C1 Specified in advice from TGA
OT2 'Other' changes - application level C2. An 'other' code is used only when no other code applies. An application using OT2 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C2 Specified in advice from TGA
OT3 'Other' changes - application level C3. An 'other' code is used only when no other code applies. An application using OT3 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C3 Specified in advice from TGA
OT4 'Other' changes - application level C4. An 'other' code is used only when no other code applies. An application using OT4 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C4 Specified in advice from TGA
OTX 'Other changes - application level CN. This code is to be used to request CN level changes to multiple ARTG entries. This code must be used in addition to other change types that result in a CN level application. The details of the additional products, including relevant ARTG IDs must be provided. Additional processing time will be required. N As required CN 9D(2C)

The type of application you need to make.

Status codes
Code Prior TGA approval required? Description
A Yes A change made under section 9D or section 23 of the Act
SRR Yes Safety Related Request: a change made under section 9D(2) of the Act
SAR Yes Self-Assessable Request: a change made under section 9D(1) or section 9D(3) of the Act
N Yes Notifications: a change made under section 9D(2C) of the Act. TGA approval is made automatically upon lodgement and payment of the application.
NEW Yes New application for registration required
O No

The TGA does not need to be informed of changes subject to status code 'O' - no application is submitted.

Note 1:Change codes for 'O' status changes are not included in the application portal.

Note 2: Changes with status 'O' have been included in the changes table for clarity and completeness and do not imply that this information is required for evaluation of an equivalent new product.

ASK Yes This applies only where one of the 'other' change codes (OT1, OT2, OT3 or OT4) is used. Refer to the Changes not in the changes table
Assurance codes
Code Description
1 The 'new' goods are intended to replace the existing goods in use
2 The only difference between the 'new' goods and the existing goods is the name
3 The only differences between the 'new' goods and the existing goods are related to the indications for use and/or the directions for use
4 No additional indications have been introduced or directions for use altered (other than change to wording)
5 No aspects of the labelling, PI, CMI, pharmaceutical data or other product details (including manufacturing process), have been changed or are to be changed, other than changes nominated in this application and those made in conformity with the changes table
6 The labelling for the new pack size is unchanged, other than to indicate the new pack size number/volume
7 The only changes made are those which bring the label into compliance with requirements of the Labelling Order, or Schedule 2 to the Therapeutic Goods Regulations 1990
8 The change is in compliance with a requirement introduced in the most recent version or amendment of the SUSMP (Poisons Standard).
9 The nominated manufacturer is licensed to manufacture goods of this type
10 The container type (as defined in TGA approved terminology for medicines) is unchanged and container material is unchanged
11 A stability testing protocol has been approved for this product and a copy of the approval letter is attached
12

All of the following apply:

  • Neither the existing nor the new material is a modified starch.
  • The changeover has been validated.
  • At least 6 month's stability data have been generated at the maximum recommended storage temperature on product manufactured using the new type of starch, or 3 month's data at a temperature at least 10°C higher than the maximum recommended storage temperature.
  • Stability testing will continue for the full term of the product's shelf life and any batches not meeting specifications will be withdrawn from the market immediately and the TGA notified immediately.
13

All of the following apply:

  • The changeover has been validated* and the Sponsor is satisfied that the change will not adversely affect the stability of the product
  • Stability testing will continue for the full term of the product's shelf life and the TGA advised immediately of any batches not meeting specifications.

*Note: Validation data will be provided during a GMP inspection or upon request by the TGA within 3 months following the request

14 No new text or graphics have been introduced
15 Intentionally blank
16 The new container/closure system has demonstrated equal or better moisture protection in the USP test for Containers - Permeation (water vapour transmission) to that of the existing container/closure system
17 The information on the container label is not less than the information on the primary pack
18 Intentionally blank
19 Manufacturing method and specifications, other than visual identification, have not been changed
20 Two production batches have been tested according to the approved stability protocol and all results fall within the acceptance criteria, as specified in the approved stability protocol
21 The changes are in accordance with s.9D(1) of the Act
22 Intentionally blank
23 Intentionally blank
24 Where a measuring device is being introduced or changed, it includes calibrations exclusively in metric units and will allow all the doses shown on the label to be measured accurately
25 The container type (as defined in TGA approved terminology for medicines) is unchanged
26 Intentionally blank
27 A copy of the current specification plus a copy of the new specification, with the changes highlighted, have been supplied
28 Intentionally blank
29 A copy of the current label of the goods together with a draft copy of the new package insert have been supplied
30 A copy of the current label and package insert of the goods have been supplied
31 A copy of the written advice from TGA advising the use of this change code for the requested change to the product has been supplied