Enforcement priorities versus written rules — does this still hold?

Enforcement priorities versus written rules — does this still hold? — that is the question, and I have not found it answered plainly anywhere I have looked.

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.

I disagree with the framing of Enforcement priorities above, and I think it is a substantive disagreement rather than a terminological one. Setting out why, so it can be checked.

The reasoning depends on an assumption that is doing a lot of work and is never stated. If the assumption holds, the conclusion follows. I do not think it holds generally.

The opening post is right about the mechanism and I think understates the practical bit.

Anything written here about regulatory status should be assumed stale after twelve months, which is why the documentation pages carry review dates.

That is all I can say without guessing.

Coming back to post #2, because the follow-up matters more than the original answer.

Import rules for personal quantities differ from commercial import rules and both differ by country. Establishing your own position is not something a forum can do for you.

Nothing above should be read as advice about what anyone else should do.

On post #2 — agreed on the reasoning, with one qualification.

Approval versus licensing: a compound can be approved for a specific indication in one country and not approved at all in another. Tracking jurisdictional approval is tedious but necessary.

The strength of my opinion here exceeds the strength of my evidence.

Confirming post #4 from a second method, which matters more than confirming it from a second person.

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

Caveat: everything above assumes the paperwork is what it says it is.

If you are new and reading this thread for the answer to Enforcement priorities: the answer is conditional, the conditions are in the third reply, and the rest of the thread is worth skipping.

Building on post #8 rather than restating it.

Adding the boring version of Enforcement priorities, because the interesting version keeps getting posted and the boring one is usually right.

Check the ordinary explanations, in order, and stop when one of them accounts for what you are seeing. Most of the time the second one does.

Compounding and pharmacy rules: some jurisdictions allow a pharmacy to compound a drug that is not on the market under specific conditions. The conditions are strict and vary by jurisdiction. Generalising from one country's rules to another's is unreliable.

Where I would look next, rather than where I would stop.

My understanding of Enforcement priorities is a few years old and may have been superseded. If it has been, I would genuinely like to know rather than keep repeating it.

The claim about Enforcement priorities upthread is stronger than its source supports. I have read the source. The source says "associated with" and the post says "causes".

Answering the question post #9 raises rather than the one it answers.

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

Somebody will have a better source than mine, and I hope they post it.