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Tech Alert: New TGA resource tool: Checklists for 9D(1)(a) requests to vary ARTG

06 Dec 2023 11:57 AM | Anonymous member (Administrator)

Today's tech alert provides information for sponsors on the TGA’s new published Checklists for 9D(1)(a) requests to change (vary) an ARTG entry.

The new checklists are designed to be used by a sponsor (or agent) who wants to request the following changes to their medicine's ARTG entry under paragraph 9D(1)(a) of the Act: the checklists will assist sponsors who want to make the following changes:

1. Correct an omission or mistake made at the time the medicine was listed; and/or

2. Replace a Proprietary Ingredient (PI) with the individual ingredients included in the PI’s formulation (where there is no change to the formulation, ingredients or quantity).

This tech alert also clarifies the TGA’s interpretation of ‘separate and distinct’ with regard to Section 9D applications, and provides additional information to assist sponsors in determining the circumstances under which their application to change (vary) an ARTG entry may be eligible.

Examples of what are potentially eligible and ineligible for section 9D(1)(a) applications are included at the end of this alert.

Please read the full alert for all information and details.

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