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Process to change a registered OTC medicine
V1.2, June 2017
Step 7 - Changing more than one medicine
Skip this step if you only want to change one OTC medicine.
If you want to change more than one medicine you will usually need to submit a separate application for each medicine that you want to change (Step 8).
Making identical changes to more than one medicine
You can submit a single application to make identical changes to more than one OTC medicine only when all of the following apply:
- The change codes correspond only to applications made under section 9D of the Act (determined in step 2).
- The specific details of the change are identical and common to each medicine in the application.
- Take into account both the currently registered details and the proposed details for each medicine when you assess whether the change is identical.
- If one or more of the medicines include a unique change you will need to submit separate applications.
- The changes do not require separate evaluation in the context of each medicine.
- Most C2 to C4 level changes require separate evaluation for each medicine.
Information for identical changes to more than one medicine
To submit a single application to make identical changes to more than one medicine
- Provide separate copies of the relevant supporting documents for each medicine that the changes apply to.
- Select the application form in Business Services (Step 8) titled Change Multiple ARTG Entries.
Adding the same manufacturer to four medicines and changing font size on the label for only one medicine
You would need to submit two applications:
- one application to add the manufacturer to three of the medicines, as this is an identical change to all three medicines
- a second separate application to add the manufacture and make the changes to the label of the fourth medicine.
Adding an overseas manufacturer to several medicines.
Although the relevant change code (MOS) is common to all of the medicines, the specific additional overseas manufacturing site differs for each medicine. As the additional manufacturing sites are not identical for each medicine the sponsor cannot submit these changes on a single application form.
Adding a new 'fast' claim to the labels of several medicines with different formulations
The appropriateness of this claim needs to be evaluated separately for each medicine and you would need a separate application for each medicine.