Minor Updates that reflect an update to the TMA
We note that Appendix A of the Submission Guidance states that a "Minor Update" submission and fee can apply if "a statement in the APS is revised to reflect an update to the Terms of Market Authorization content on which it is based".
If there is a new dosing/administration option available for a product, can an APS be revised and submitted as a Minor Update so that it reflects the TMA? We presume that revising a statement such as "Once capsule once daily" to "Once capsule/tablet once daily" would qualify, but adding a new statement or outright promoting the TMA update would not qualify for a Minor Update (e.g., a callout stating "Now available in tablets"). Please let us know if the PAAB has a stance on what the nature of these TMA updates can be, and how our APSs can be revised to help minimize fees.
Thank you in advance!
Hi @dmauri ,
You are correct that revising an existing statement to an updated version of the same statement would be acceptable as a minor update, assuming it is only one presentation that is changing within the piece and the rest of the piece is confirmed to be identical.
Regarding the addition of a new statement, such as ‘now available in tablets’, we can consider that for a minor update assuming a dosing presentation is already present in the piece, and again, the remainder of the piece is confirmed to be identical and it’s only this dosing presentation that is being updated.
As a reminder, when submitting a piece as a minor update, no new approval number is issued. The approval window (12 month period) stays the same as the original submission. If a new 12-month window is desired, the piece should be put through a full review (not as a minor update).
@danthony Thank you for the clarification!