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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

29 November 2015

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The same change for many products?

A sponsor can submit an application to make an identical change(s) to multiple OTC products. This type of application applies only when the change does not require separate assessment for individual products or when there is no change unique to one particular product within the group that requires separate assessment.

An example of an acceptable application of this type is where a sponsor requests a change to the same principal licensed manufacturer for a range of registered products. However, if the sponsor wants to make an additional change to one out of the group of products (e.g. the addition of an additional Australian manufacturing site), then that product should not be included with the multiple change application. The changes for that product should be submitted as a standalone application.

Each ARTG entry included in the application must contain current and complete details for the entire submission to pass validation in eBS. If the application fails validation, then the ARTG entries require individual updating through eBS to include the new change(s) and correct the records. Individual applications require individual payment of the relevant fees for each submission made to the TGA.

Sponsors of applications involving more than one product should submit separate, individual product-specific copies of the relevant supporting documents for each Australian Registration (AUST R) number that the change applies to, for product-specific record-keeping purposes.

Applications involving 'Groupable' changes cannot be submitted as part of an application involving more than one product; 'Groupable' changes require a separate application (see 'Groups Order - summary') for each product.

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