| 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:
| A | 1, 2 | C2 | 23 |
| GPU | Proprietary name (if grouping applies) where:
| 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. For example, adding an indication for a 500mg paracetamol tablet from the list of representative indications in ARGOM's paracetamol guideline | 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. For example, including an indication for a 500mg paracetamol tablet which is not included in the list of representative indications in ARGOM's paracetamol guideline. | 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 | 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. For example, changes to the paediatric dosage recommendations for an ibuprofen oral suspension for infants and children 3 months to 12 years to be consistent with the directions in ARGOM's ibuprofen guideline. | 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. For example, extending the patient population for an ibuprofen oral suspension to include use in neonates. | 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:
| SRR | 5 | C1 | 9D(2) |
| LRA | Changes to the label to ensure compliance with RASML other than changes described in LSR | SAR | 5 | C1 | 9D(3) |
| LNT | Changes to bring a label into full compliance with TGO 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) |
| 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 OTC schedule, except where LSC applies | A | 5, 8 | C2 | 9D(3) |
| LSC | 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 OTC schedule where no such products have previously been approved as an OTC medicine | A | 5, 8 | C3 | 9D(3) |
| LSU | Changes on label (signal headings, warning statements) in compliance with new SUSMP requirements, other than LSF or LSC | SRR/SAR | 5, 8 | 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 | C1 | 9D(2) |
| LCF | Colour, or type size change (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 (including rewording of pre-existing text) where there is no requirement for supporting module 4 and/or module 5 data (may entail the provision of quality data such as dissolution data to support a 'fast' claim), other than as specified in change LAB | 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) |
| KPD | Introduction of a package insert where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, inclusion of a package insert with a section on absorption based on module 5 data which includes claims pertaining to 'fast' absorption. | A | 5, 29 | C3 | 9D(3) |
| KRI | Removal of a package insert | 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) |
| Changes to package insert: since the package insert is treated as part of the label, select the appropriate change code(s) from the 'Labelling (including package insert) and product detail changes' section of the Changes Table | |||||
| LAB | Minor label editorials that have no regulatory compliance impact (under the Therapeutic Goods Act 1989). The changes are limited to the following:
| 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 | C2 | 9D(3) |
| PSD | Pack size – deletion | N | 5 | CN | 9D(2C) |
| Dosage form (as defined in Other terminology) | NEW | ||||
| PVI | Visual identification | SAR | 5, 13, 19, 27 | C1 | 9D(3) |
| PSL | Shelf life - increase (other than in change PSP) | A | 5 | C2 | 9D(3) |
| PSR | Shelf life - decrease | N | 5 | CN | 9D(2C) |
| PSP | Shelf life - increase, where this is in accordance with a TGA approved protocol for self assessable shelf life extensions for that particular product (refer ARGOM Appendix 2, section 9.10 & 9.10.1) | SAR | 5, 11, 20 | C1 | 9D(3) |
| PPR | Request for a stability testing protocol for self assessable shelf life extensions for a specific product (refer ARGOM Appendix 2, section 9.10) | A | 5 | C2 | 9D(3) |
| PMI | Sterility status | A | 5 | C2 | 9D(3) |