What a regulator's shortage notice actually authorises — what changed since

The question in the title: What a regulator's shortage notice actually authorises — what changed since I will give what I have already checked below so nobody repeats it.

Asking what a regulator's document actually says, since the summaries of it disagree.

I have the primary document open and two secondhand accounts of it that cannot both be right. The primary document is narrower than either.

My question is whether I am reading the scope of it correctly, and what the correct reading rules out as well as what it permits.

Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.

Everything in the opening post holds. The case it does not cover is the one I have.

Post-authorisation safety commitments are public and are one of the more useful sources for what a regulator considered uncertain at approval.

A regulator's public assessment report is usually the single best free source on a compound's evidence base, and it is almost never cited here.

This is the version I would want a new member to read first.

Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.

I am aware this is the third time this month I have made this point.

Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.

The arithmetic in post #7 is right; the assumption feeding it is the part to check.

An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.

On post #7 — agreed on the reasoning, with one qualification.

Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.

Noting that I have skin in this question and have tried to discount for it.

Adding thanks rather than a view. I do not have a view worth the space.

Fine by me. I had wanted a stronger conclusion and there is not one available.

Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.

This follows post #12 rather than contradicting it.

Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.

Worth separating two things that post #12 runs together.

If you can confirm or contradict a position for your own region, please date the answer. An undated regional claim is the least useful thing in this category.

The right answer here may simply be that it has not been measured.