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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

15 April 2013

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Change to an entry in the ARTG

Section 9D of the Act refers to how the Secretary (or Secretary's Delegate, the 'Delegate') may vary entries in the ARTG.

Applications for changes to medicines that require minimal assessment by the Delegate are denoted by the 'Status Codes' "SRR" (safety related request) or "SAR" (self assessable request) in the Changes Table. The Safety Related Requests (SRR) are approved by the Delegate under section 9D(2) of the Act; the Self Assessable Requests (SAR) are approved by the Delegate under section 9D(1) or section 9D(3) of the Act. These types of changes are included in application level C1 and only require the payment of an application fee and do not require payment of evaluation fees.

All other changes denoted by 'A' as the status code in the Changes Table made under Section 9D of the Act require significant assessment by the Delegate and therefore require payment of evaluation fees as well as application fees. The applications for some change types denoted by 'A' as the status code are made under section 23 of the Act.

All applications under section 9D or section 23 of the Act require approval before the sponsor can proceed with the change. Should the application be unsuccessful, the TGA will provide a rejection letter which contains details of procedures for review of the decision. 

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