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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

29 November 2015

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Changes Table - codes

Sponsors must select a change code(s) from the Changes Table which describes the proposed change(s) to the medicine. More than one change code can be selected in an application. Selecting these codes will determine the assurances required and the application level (C1-C4) applicable for the selected change.

It is the responsibility of the sponsor to ensure the accurate selection of the change codes so that the assurances and application level categories pertaining to each change code are correct.

Where a description of the proposed change cannot be found in the Changes Table, contact the staff of the OTC Medicines Evaluation section (refer What if the proposed change is not in the Changes Table?).

Status codes

The status codes appear in the Changes Table to provide sponsors with simple guidance on the type of application required when changing their existing good.

Code Description
A An approvable change made under section 9D or section 23 of the Act.
SRR Safety Related Request: an approvable change made under section 9D(2) of the Act.
SAR Self Assessable Request: an approvable change made under section 9D(1) or section 9D(3) of the Act.
NEW New application for registration required.
O No prior approval required. Changes with status 'O' have been included for completeness and do not imply that this information is required for evaluation of an equivalent new product
ASK This applies only where the 'OTH' (other) change code is used. The sponsor must contact the OTC Medicines Evaluation section before submitting an application with this change code (refer What if the proposed change is not in the Changes Table?).

Documentation and assurance codes

Code Description
E Evidence to support the change where an ARTG entry is to be corrected.
L A copy of the current label of the goods plus a draft copy of the new label, with the relevant changes highlighted have been supplied.
PI A copy of the current Product Information (PI) of the goods plus a draft copy of the new PI, with the relevant changes highlighted, have been supplied.
P The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) schedule level for the new pack size(s) has been selected on the application form.
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.
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.
  1. Neither the existing nor the new material is a modified starch; and
  2. The changeover has been validated; and
  3. 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; and
  4. 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 Office of Medicines Authorisation.
  1. The changeover has been validated* and the Sponsor is satisfied that the change will not adversely affect the stability of the product; and
  2. 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 ARGOM Appendix 2 Guidelines on quality aspects of OTC medicines).

14. No new text or graphics have been introduced.

The change of material is one of the following:

  1. Polystyrene to PVC, polyethylene, polypropylene or glass;
  2. PVC to polyethylene, polypropylene or glass;
  3. Polyethylene to glass or polypropylene of density ≥ 0.89;
  4. From one density of polyethylene to a higher density; or
  5. Any change between glass, polyethylene of density ≥ 0.95, and polypropylene of density ≥ 0.89.
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.

The change to the plastic component is one of the following:

  1. PVC to PVC/PVDC or 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').

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.

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