OTC and registered complementary medicines
This guidance outlines the kinds of variations to registered non-prescription medicines that are considered as requests made under the provisions of section 9D(2C) of the Therapeutic Goods Act 1989 (known as ‘notifications’). The conditions outlined below the description of each variation type must be met for the request to be processed as a notification.
Categories:
- Labelling (including package insert) and product detail changes
- Formulation changes - active ingredients
- Formulation changes - excipient ingredients
- Quality control changes - finished product specifications
- Quality control changes - starting material specifications
- Packaging changes
- Manufacturing changes - finished product
Labelling (including package insert) and product detail changes
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.
A change to the font, letter height or text size on a label for the medicine, except where the change is to the letter height or text size on the main panel of the label.
Conditions
- No aspects of the labelling, Product Information (PI), Consumer Medicines Information (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.
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.
Conditions
- 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.
LLN: Introduction of a 'new' or a 'value pack' flash - see LAB for removal of a 'new' or a 'value pack' flash
Introduction of a 'new' or a 'value pack' flash to an approved medicine label, see LAB for removal of a 'new' or a 'value pack' flash.
Conditions
- 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.
LSP: Changes to sponsor details including name and/or logo (inclusion of a logo or change to an existing logo) except where LAB applies
Changes to sponsor details, including logos, stated on the approved medicine label, other than where the sponsor name is part of the approved name of the medicine (except where LAB applies).
Conditions
- 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.
PLN: Addition of a pack size for liquids/semi solids where the new pack size falls within the pack size range specified in the ARTG entry of the medicine subject to the change. See also PLS.
Conditions
- 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 (see also PLS)
- The labelling for the new pack size is unchanged, other than to indicate the new pack size number/volume.
- The container type (as defined in TGA Approved Terminology for Medicines) is unchanged and container material is unchanged.
- The following are applicable:
- The changeover has been validated* and the Sponsor is satisfied that the change will not adversely affect the stability of the product; and
- 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 (also see Guidelines on quality aspects of OTC applications).
PSC: Recommended storage conditions - more restrictive
Change to the recommended storage conditions for the medicine, to make these more restrictive.
Conditions
- 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.
PSD: Pack size - deletion
Conditions
- 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.
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 pack size range specified in the ARTG entry of the medicine subject to the change. See also PSZ.
Conditions
- 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. The labelling for the new pack size is unchanged, other than to indicate the new pack size number/volume (see PLS. PMZ and PSZ).
- The container type (as defined in TGA Approved Terminology for Medicines) is unchanged and container material is unchanged.
PSR: Shelf life - decrease
Decrease in the approved Shelf life of the medicine.
Conditions
- 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.
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)
Conditions
- 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. (see KMD)
Formulation changes - active ingredients
AOV: Overage - decrease or removal
Reduction or removal of previously approved overages allowed for the amount of the active ingredient(s) in the medicine.
Conditions
- 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.
Formulation changes - excipient ingredients
EST: Type of starch (no change to quantity)
Change to the type of starch used as an excipient ingredient in the medicine, where there is no change to the quantity.
Conditions
- 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.
- Neither the existing nor the new material is a modified starch.
- The changeover has been validated.
- Stability data for at least 6 months have been generated at the maximum recommended storage temperature on product manufactured using the new type of starch, or for at least 3 months 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.
Quality control changes - finished product specifications
QFP: Change from one default standard (as defined in the Therapeutic Goods Act 1989) to another or from a 'company' or 'in-house' specification to a pharmacopoeial specification.
Changes to the approved finished product specifications to ensure that the medicine complies with the requirements of a default standard (i.e. a monograph in the BP, USP-NF or EP) (see the Therapeutic Goods Act 1989).
This may involve a change from a default standard currently identified in the specifications to another; or the adoption a default standard in place of an ‘in house’ specification.
Conditions
- This includes deletion of the existing pharmacopoeial tests and limits.
- If adding a default standard and consequently removing any tests that are duplicated by this addition, any other tests included in the specifications (e.g. residual solvents in the finished product or friability) must not be deleted or changed.
- 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.
- A copy of the current specification plus a copy of the new specification, with the changes highlighted, have been supplied.
Quality control changes - starting material specifications
QSP: Change from one 'default standard' (as defined in the Therapeutic Goods Act 1989) to another or from a 'company' or 'in-house' specification to a pharmacopoeial specification
Changes to the approved starting material specifications such that the material must comply with the requirements of a default standard (i.e. a monograph in the BP, USP-NF or EP) (see the Therapeutic Goods Act 1989).
This involves a change from a default standard currently identified in the specifications to another; or adopting a default standard in place of an ‘in house’ specification. If the latter, any additional non-pharmacopoeial specifications must not be deleted or changed.
Conditions
- This includes deletion of the existing pharmacopoeial tests and limits.
- If adding a default standard and consequently removing any tests that are duplicated by this addition, any other tests included in the specifications (e.g. residual solvents in the finished product or friability) must not be deleted or changed.
- 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.
Packaging changes
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 specific type
Changes to the container material where the container is a blister pack, the medicine is 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 or
- 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’).
Conditions
- 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.
- The changeover has been validated and the Sponsor is satisfied that the change will not adversely affect the stability of the product.
It is expected that appropriate validation studies will be performed and that the results will be available on request or during the course of GMP inspections.
Where a manufacturing process has not been fully validated on production scale batches at the time of approval of a new medicine, the sponsor should provide a written assurance that the manufacturing process will be validated, consistent with the requirements of the Code of GMP, for the first two or three production scale batches. The sponsor should also provide an assurance that the manufacturer’s validation reports on these batches will be made available, if requested for review by the TGA, within three months of release of the batches. The performance of this validation will be made a condition of registration of the medicine (also see Guidelines on quality aspects of OTC applications).
-
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.
- The container type (as defined in TGA Approved Terminology for Medicines) is unchanged.
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 specific type
Changes to the container material where the container is a bottle, the medicine is 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 or
- PVC to polyethylene, polypropylene or glass or
- Polyethylene to glass or polypropylene of density ≥ 0.89 or
- From one density of polyethylene to a higher density or
- Any change between glass, polyethylene of density ≥ 0.95, and polypropylene of density ≥ 0.89.
Conditions
- 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.
Validation data may be reviewed during a GMP inspection or upon request by the TGA within 3 months following the request (also see Guidelines on quality aspects of OTC applications).
- 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.
- 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.
- The container type (as defined in TGA Approved Terminology for Medicines) is unchanged.
KCL: Closure - other than changes in KCM or MDA
Changes to the container closure other than where the closure also serves as a metering component or the changes refer to the pump or pump components of a metered-dose aerosol.
Conditions
- 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.
- The changeover has been validated and the Sponsor is satisfied that the change will not adversely affect the stability of the product.
Validation data may be reviewed during a GMP inspection or upon request by the TGA within 3 months following the request (also see Guidelines on quality aspects of OTC applications).
- Stability testing will continue for the duration of the product's shelf life and the TGA advised immediately of any batches not meeting specifications.
KMO: Removal of a measuring device where other means of accurately measuring the dose are readily available.
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. The change must not include changes to the directions for use or any other changes to labelling such as reformatting. A copy of current and proposed label must be supplied if the label is changed.
Conditions
- 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.
KRR: Removal of refill pack
Removal of a medicine's refill pack.
Conditions
- 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.
Manufacturing changes - finished product
AMS: Addition of steps of manufacture, other than for sterile products where MSS or MST applies
Identification of additional steps in the manufacture of the finished product that can be performed by an approved manufacturer, where the product is non-sterile.
Conditions
- 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.
- The nominated manufacturer has acceptable GMP evidence to perform the relevant steps of manufacture of the finished product.
MMA: Addition of a manufacturer (includes site of manufacture), other than for sterile products where MSS or MST applies
Addition of a new manufacturer approved to perform any or all steps in the manufacture of the finished product, where the product is non-sterile.
Conditions
- 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.
- The nominated manufacturer has acceptable GMP evidence to perform the relevant steps of manufacture of the finished product.
MMD: Deletion of a manufacturer (includes site of manufacture)
Cessation of the use of a manufacturer approved to perform any or all steps in the manufacture of the finished goods at an approved site.
Conditions
- 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.
MSD: Deletion of steps of manufacture
Reduction of the number of steps that can be performed by an approved manufacturer in the manufacture of the finished product.
Conditions
- 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.
MSS: For sterile products, the addition of a manufacturer or 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]
For a sterile product:
- 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].
Conditions
- The finished product is sterile.
- 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.
- The nominated manufacturer has acceptable GMP evidence to perform the relevant steps of manufacture of the finished product.