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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

15 April 2013

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What if the proposed change is not in the Changes Table?

If the proposed change is not described in the Changes Table, contact the staff of the OTC Medicines Evaluation Section. The absence of the proposed change from the Changes Table does not imply that the sponsor may proceed without requesting prior approval from the TGA.

If it is determined, following consultation with the OTC Medicines Evaluation Section, that none of the specific change codes are relevant to the proposed change, then the change code 'OTH' (other) will be used. The OTC Medicines Evaluation section will provide written confirmation to the sponsor, typically in the form of an email, endorsing the use of the 'OTH' change code and advising the application level (C1-C4) appropriate for the particular change. The application level will be determined in accordance with the OTC application categorisation framework for changes to approved medicines.

In general, if the proposed change is a quality related change or a change to the labelling that doesn't require the provision of safety or efficacy data, the application level is likely to either be C1 or C2. If the proposed change relates to the labelling or other product documentation (such as the product information) and it requires supporting safety or efficacy data but is not a change involving a new indication or directions for use, then it is likely to be in C3.

Written advice from the TGA confirming use of the OTH change code must be included with the application as an attachment to the cover letter and should be explicitly referred to in the cover letter.

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