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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

29 November 2015

Book pagination

Changes Table

Label changes (including package insert)

Change codes Label changes (including package insert) Status A/D* Appln level Applicable section of the Act
GPN

Proprietary name (if grouping applies) where:

  1. the product name does not include an umbrella branded name or
  2. if it does contain an umbrella branded name, then the umbrella segment is not categorised as requiring a higher level of assessment
A 1, 2, L C2 23
GPU Proprietary name (if grouping applies) where the product name includes an umbrella branded name and where the umbrella segment is categorised as requiring a higher level of assessment A 1, 2, L C3 23
Proprietary name (if grouping doesn't apply) NEW
GIN New therapeutic indications (if grouping applies) where there is no requirement for supporting data A 1, 3, L C2 23
GID New therapeutic indications (if grouping applies) where supporting data or a justification for not providing supporting data is required A 1, 3, L 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, L C2 9D(3)
LIS Therapeutic indications - removal of sub-set of indications from label SRR 5, L C1 9D(2)
LIR Therapeutic indications - addition of registered indications to label A 5, L C2 9D(3)
GDU Directions for use - e.g. dosage instructions (if grouping applies) where there is no requirement for supporting data. (See also LIW) A 1, 3, L C2 23
GDD Directions for use - e.g. dosage instructions (if grouping applies) where supporting data or a justification for not providing supporting data is required. (See also LIW) A 1, 3, L C4 23
Directions for use (if grouping doesn’t apply) NEW
PSC Recommended storage conditions - more restrictive SAR 5 C1 9D(3)
PST Recommended storage conditions - less restrictive A - C2 9D(3)
LSR Addition of more restrictive safety-related statements SRR 5, L C1 9D(2)
LSF Changes on label (signal headings, warning statements) in compliance with new SUSMP requirements, where the change in scheduling is from 'Prescription Only Medicine' (Schedule 4) to a lower schedule A - C2 9D(2) / 9D(3)
LSU Changes on label (signal headings, warning statements) in compliance with new SUSMP requirements, other than LSF SRR / SAR 5, 8, L C1 9D(2) / 9D(3)
LLO Changes to bring a label into compliance with the Labelling Order - other than changes to the proprietary name, indications or directions for use SRR / SAR 5, 7, L C1 9D(2) / 9D(3)
LLR Addition of a required representation to a label (Part 2 of Schedule 2 to the Therapeutic Goods Regulations) SRR 5, 7, L C1 9D(2)
LCF Colour, font, type size only (no change in label copy) SAR 5, L C1 9D(3)
LGR Introduction of new graphics/icons (other than as specified in change SSP & KSP) A - C2 9D(3)
RGR Removal of a graphic (other than as specified in change SSP) SAR 5, L C1 9D(3)
LFO Reformatting of pre-existing text (ie. moving of blocks of text and not rewording - see LIW, LRT) SAR 5, L C1 9D(3)
LRT Rewording of pre-existing text without altering meaning (other than indications or directions for use - see LIW) A - C2 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.) where there is no requirement for supporting data A - C2 9D(3)
LDD 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.) where supporting data or a justification for not providing supporting data is required A - C3 9D(3)
COO Addition or deletion of a country of origin statement e.g. 'Made in xx' SAR 5, L C1 9D(3)

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Sponsor changes

Change codes Sponsor changes Status A/D* Appln level Applicable section of the Act
SSP Sponsor name/logo/sponsor address (same sponsor of goods) and/or change to manufacturer/supplier details on label SAR 5, L C1 9D(3)

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Product detail changes

Change codes Product detail changes Status A/D* Appln level Applicable section of the Act
PSZ Pack size - other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) (see also KBT, KGL, KBL and KOT) SAR 5, 6, 10, L, P C1 9D(3)
PLS Pack size - liquids/semi-solids SAR 5, 6, 10, 13, L, P C1 9D(3)
PMZ Pack size - metered dose aerosols A - C2 9D(3)
Dosage form (as defined in TGA Approved Terminology for Medicines) NEW
PVI Visual identification SAR 5, 13, 19 C1 9D(3)
PSL Shelf life - increase (other than in change PSP) A - C2 9D(3)
PSR Shelf life - decrease SAR 5 C1 9D(3)
PSP Shelf life - increase (in accordance with an approved stability testing protocol for that product) SAR 5, 11, 20 C1 9D(3)
PPR Approval of a stability testing protocol for a specific product A - C2 9D(3)
PSC Recommended storage conditions - more restrictive SAR 5 C1 9D(3)
PST Recommended storage conditions - less restrictive A - C2 9D(3)
PMI Sterility status/technique A - C2 9D(3)

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Formulation changes - active ingredients

Change codes Formulation changes - active ingredients Status A/D* Appln 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 ranges' in ARGOM Appendix 2, section 4.1 NEW
AOV Overage - decrease SAR 5 C1 9D(3)
AOA Overage - increase A - C2 9D(3)
GPA Change to amount of an excipient ingredient within a proprietary ingredient which contains an active substance (e.g. a direct-compression paracetamol mix) (if grouping applies) A 1 C2 23
Change to a proprietary ingredient which contains an active ingredient, other than as above in change GPA NEW

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Formulation changes - excipient ingredients

Change codes Formulation changes - excipient ingredients Status A/D* Appln level Applicable section of the Act
GPI Removal and/or addition of a fragrance, flavour, printing ink or colouring agent (if grouping applies), other than change ERT A 1, 13 C2 23
Removal or addition of a fragrance, flavour, printing ink or colouring agent (if grouping doesn't apply) NEW
ERT

Removal of 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 (eg. deletion from the label of declared ingredients that are no longer relevant; change to visual identification and finished product specifications) which should also be addressed in accordance with the 'Changes Table'.

SAR 5 C1 23
Addition of excipient other than those above in change GPI NEW
Deletion of excipient other than those above in change GPI NEW
GEX Amount of excipient (if grouping applies) A 1 C2 23
Amount of excipient (if grouping doesn't apply) – see also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3 NEW
EST Type of starch SAR 5, 12 C1 9D(3)
EWI Change to ingredients within a proprietary ingredient which is a flavour, fragrance, printing ink or colour (proprietary ingredient has same name) SAR 5, 13 C1 9D(3)
EWA Change to ingredients within a proprietary ingredient which is an excipient (other than above in change EWI) A - C2 9D(3)

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Quality control changes - finished product specifications

Change codes Quality control changes - finished product specification Status A/D* Appln level Applicable section of the Act
QFX Specification ranges - more restrictive O
QFE Specification ranges - less restrictive A - C2 9D(3)
QFT Addition of an extra test O -
QFU Deletion of an existing test A - C2 9D(3)
QFA Analytical method - to comply with amendments to a standard (e.g. the BP or a Therapeutic Goods Order) O
QFB Analytical method - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity) O
QFC Analytical method - other than as specified above in change QFB A - C2 9D(3)
QFS Expiry specification ranges following changes to the BP or the General standard for tablets pills and capsules or changes to the USP where a USP monograph has been approved by the TGA in relation to the product O

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Quality control changes - starting material specifications

Change codes Quality control changes - starting material specifications Status A/D* Appln level Applicable section of the Act
QSX Range - more restrictive O
QSE Range - less restrictive A - C2 9D(3)
QST Addition of an extra test O
QSU Deletion of an existing test A - C2 9D(3)
QSA Analytical method - to comply with amendments to a standard (i.e. the BP, EP, USP or a Therapeutic Goods Order) O
QSB Analytical method - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity) O
QSC Analytical method - other than as specified above in change QSB A - C2 9D(3)
QSM Manufacturer of starting material (specifications unchanged) O
QSS Supplier of starting material O

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Packaging changes

Change codes Packaging changes Status A/D* Appln 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 is of a type listed in assurance 15 SAR 5, 10, 13, 15 & 16 C1 9D(3)
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 is of a type listed in assurance 18 SAR 5, 10, 13 & 18 C1 9D(3)
KOT Container material - other than in changes KBT, KGL or KBL A - C2 9D(3)
KCL Closure SAR 5, 13 C1 9D(3)
KSL Tamper evident seal - addition (including label notice to alert consumers to presence of seal) O
KSX Tamper evident seal - removal (including removal of label notice re seal) O
KWA Inert wadding material—addition, substitution or removal where stability is not affected by the action O
KDA Desiccant - inclusion in container A - C2 9D(3)
KDX Desiccant - removal from container A - C2 9D(3)
KPP Specifications of primary pack (other than labelling) O
KSP Introduction of a measuring device (e.g. spoon, cylinder) or applicator (e.g. finger cot); this change can include graphical representation of the device on the label (copy of current & proposed label must be supplied if label is changed) SAR 5 C1 9D(3)
KMD Changes to existing measuring device (e.g. spoon, cylinder) or applicator supplied with the goods or removal of a measuring device or applicator, where other means of accurately measuring or applying the dose are readily available SAR 5 C1 9D(3)
KPA Introduction of a primary pack (no new text or graphics) SAR 5, 14 C1 9D(3)
KPI Introduction of a package insert where there is no requirement for supporting data A - C2 9D(3)
KPD Introduction of a package insert where supporting data or a justification for not providing supporting data is required A C3 9D(3)
KRI Removal of a package insert where there is no requirement for supporting data A - C2 9D(3)
KRD Removal of a package insert where supporting data or a justification for not providing supporting data is required A C3 9D(3)
KPX Removal of a primary pack SAR 5, 17 C1 9D(3)
KRP Introduction of a refill pack A - C2 9D(3)
KRR Removal of refill pack SAR - C1 9D(3)
MDA Changes in pump or pump components of meter-dose aerosol (e.g. valve material) A C2 9D(3)

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Manufacturing changes - finished product

Change codes Manufacturing changes - finished product Status A/D* Appln level Applicable section of the Act
MMA Addition or deletion of TGA licensed Australian manufacturer (includes site of manufacture) SAR 5, 9 C1 9D(3)
AMS Addition or deletion of steps of manufacture of a TGA licensed Australian manufacturer SAR 5, 9 C1 9D(3)
MOS Addition or deletion of an overseas manufacturer (includes site of manufacture) SAR 5, 9 C1 9D(3)
OMS Addition or deletion of steps of manufacture of an overseas manufacturer SAR 5, 9 C1 9D(3)
MPR Manufacturing process (other than MBS) SAR 13 C1 9D(3)
MBS Batch size for pressurised inhalation (nasal and oral respiratory) products A - C2 9D(3)
MUP

GMP clearance NUMBER update.

Note: no other change to record permitted under this code. If amending steps of manufacture use change code OMS

SAR
(fee exempt)
5 C1 9D(3)
MST Change to manufacturing site and/or process of sterile product A C2 9D(3)

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Consumer Medicine Information (CMI)

Change codes Consumer Medicine Information (CMI) Status A/D* Appln 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 and is not to be included as a package insert.

Note: Change KPI or KPD 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 the 'Label changes' section for guidance 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

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Product Information (PI)

Change codes Product Information (PI) Status A/D* Appln level Applicable section of the Act
DPI Introduction of a PI for an existing product where there is no requirement for supporting data A - C2 9D(3)
DPD Introduction of a PI for an existing product where supporting data or a justification for not providing supporting data is required A C3 9D(3)
DRS Addition of more restrictive safety-related statements SRR 5, PI C1 9D(2)
DOT Changes other than the addition of more restrictive safety-related statements where there is no requirement for supporting data A - C2 9D(3)
DOD Changes other than the addition of more restrictive safety-related statements where supporting data or a justification for not providing supporting data is required A - C3 9D(3)

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Other

Change codes Other Status A/D* Appln level Applicable section of the Act
CTA Correction of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989 SAR E, 5, 21 C1 9D(1)
BED Brand equivalence statement intended for PBS listing where supporting data or a justification for not providing supporting data is required A C3
BES Brand equivalence statement intended for PBS listing where there is no requirement for supporting data A C2
OTH Other changes: an application using this code must include written advice from the TGA advising the application level for the change Ask

*A/D = assurances to be given and supporting documentation required for the given status to apply. Refer to Changes Table codes for an explanation of all codes used

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