Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected

Version 1.0, June 2017

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3 July 2017

Notifications for registered non-prescription medicines

Registered non-prescription medicines: This guidance came into effect on 1 July 2017.

Prescription medicines: This guidance is for information only and will come into effect on 1 January 2018.

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.

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Categories:

Labelling (including package insert) and product detail changes

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

  • 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.

  • 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.

PSC: Recommended storage conditions - more restrictive

Change to the recommended storage conditions for the medicine, to make these more restrictive.

  • 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.

PSR: Shelf life - decrease

Decrease in the approved Shelf life of the medicine.

  • 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 - 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.

  • 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.

  • 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).

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.

  • 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).

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.

  • 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').
  • 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 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.
  • 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 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.

  • 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.

KRR: Removal of refill pack

Removal of a medicine's refill pack.

  • 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.

  • 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 approval to manufacture goods of this type.

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.

  • 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 approval to manufacture goods of this type.

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.

  • 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.

  • 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.

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