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Regional · European Union · continued

EMA product information as a primary source — does this still hold? posts 91–120

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1 · go to the accepted answer.

LF
l.ferreiraTL217 Nov 2024#91
ES
e.silvaTL217 Nov 2024#92

Useful. I have added it to my own notes with the date on it.

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s.solbergTL217 Nov 2024#93

Parallel distribution is a real mechanism and produces packaging that looks unfamiliar for legitimate reasons.

Anyone with a larger sample, please post it.

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HK
h.koodziejTL2Member17 Nov 2024#94
j.erdogan, post #19: Picking up post #16: that is the part I would want checked first. EMA is the regulator with national implementation. Licensed incretin analogues are prescription-only across the EU, with some variation in specific approvals by member state. That is what the documentation says. What happens in practice is usually close. Go to post

Shortage notifications are published both centrally and nationally and the two do not always agree, usually because they are describing different things.

The reasoning is more useful than the number, which is why I have shown it.

0 likes in reply to #19 20mo
LC
lu.cabreraTL217 Nov 2024#95

Picking up post #93: that is the part I would want checked first.

Small correction to my own earlier position on EMA product information. I had the units the wrong way round, which changes the conclusion by an order of magnitude and therefore changes it entirely.

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JS
j.sorensenTL217 Nov 2024#96

On post #94 — agreed on the reasoning, with one qualification.

The question underneath EMA product information is usually "how would I tell?" rather than "what is true?", and that one has a method attached to it.

Write down what you would expect to see under each hypothesis before you collect anything. If they predict the same observation, collecting it will not help.

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an.adeyemiTL217 Nov 2024#97

The public assessment report published at authorisation is one of the best free technical documents available on any of these compounds and it is rarely cited here.

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v.salgadoTL217 Nov 2024#98
c.kuusela, post #9: On EMA product information, I would rather understate and be corrected upward than overstate and be quoted. That is a house style here and it is a good one. Go to post

Answering the EMA product information question as asked, then the question I think is meant. As asked: yes, with the qualification below. As meant: it depends on how the first measurement was taken.

0 likes in reply to #9 20mo
FP
f.petrovTL217 Nov 2024#99

I will take the caveat as seriously as the claim, which is the point of putting it there.

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v.milanoviTL3Regular17 Nov 2024 · edited#100

I disagree with the framing of EMA product information 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.

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PF
p.friskTL217 Nov 2024#101

A device-and-compound combination has one authorisation and two supply chains, and the device is more often the limiting one.

That matches what I was told, which is not the same as knowing it.

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ID
integrator_draftTL3Regular17 Nov 2024#102

Everything in post #100 holds. The case it does not cover is the one I have.

Nothing here is medical or legal advice, and this subcategory in particular attracts questions where that matters.

Not the whole picture, but the part of it I can speak to.

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f.petrovTL217 Nov 2024#103
c.okafor, post #66: On EMA product information: the maintained page in the documentation commons covers the general case with citations and a review date, which is more reliable than any reply here including this one. Go to post

Having read the whole EMA product information thread before replying: the question in the first post has not actually been answered yet, and three of us have answered a nearby one instead.

0 likes in reply to #66 20mo
VM
v.milanoviTL3Regular17 Nov 2024#104

EMA product information is worth one more sentence than it usually gets, and the sentence is the one about how the number was arrived at.

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n.chowdhuryTL217 Nov 2024 · edited#105

No disagreement from me. Posting only so the question does not look ignored.

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a.stephanopoulosTL3Regular18 Nov 2024#106

Prescription status is harmonised at the level of the authorisation and the practical route to a prescription is not.

Adding the caveat now so it does not have to be extracted later.

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KB
ka.batistaTL218 Nov 2024#107
s.lindqvist, post #57: Reimbursement is decided nationally and varies substantially between member states for the same authorised product. Go to post

Taking post #106 at face value and following it one step further.

Trying to state the EMA product information position in a way that someone who disagrees would recognise as fair, because I do not think the version in this thread passes that test.

0 likes in reply to #57 20mo
SF
sterile_fileTL3Regular18 Nov 2024#108

France: ANSM implements EU framework. Reimbursement has been narrower for weight management. Prescribing restrictions were applied during shortages, directing available product toward diabetes indications.

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an.adeyemiTL218 Nov 2024#109

I think the EMA product information question is answerable and has not been answered, which is a more optimistic position than most of this thread.

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v.salgadoTL218 Nov 2024#110

Where the EMA product information reasoning breaks down for me is the step from the group result to the individual case. That step is almost never argued for.

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s.karlsen_rphTL3Pharmacist18 Nov 2024#111

Everything in post #107 holds. The case it does not cover is the one I have.

The public assessment report published at authorisation is one of the best free technical documents available on any of these compounds and it is rarely cited here.

Speaking for myself and not for anyone else who has posted here.

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KL
k.laurentTL218 Nov 2024#112

Filing a mild objection to the consensus on EMA product information. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit.

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v.szaboTL3Analytical chemist18 Nov 2024#113

Whatever the answer on EMA product information turns out to be, the method for getting there is the same: state the assumption, do the arithmetic in public, invite the correction.

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o.vukovicTL218 Nov 2024#114
k.radich, post #45: Answering the question post #41 raises rather than the one it answers. France: ANSM implements EU framework. Reimbursement has been narrower for weight management. Prescribing restrictions were applied during shortages, directing available product toward diabetes indications. Written from notes rather than memory, which is why the… Go to post

Taking post #111 at face value and following it one step further.

Date every claim. Positions in this subcategory have moved repeatedly and the archive keeps posts permanently.

I would treat that as a working assumption and revisit it.

13 likes in reply to #45 20mo
AF
a.finnegan_rdTL2Dietitian18 Nov 2024 · edited#115
v.salgado, post #110: Where the EMA product information reasoning breaks down for me is the step from the group result to the individual case. That step is almost never argued for. Go to post

I read post #111 twice before replying, because I had assumed the opposite.

The version of EMA product information that I was taught turned out to be a teaching simplification. Useful, and not true in the way I had assumed it was.

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v.kirchnerTL218 Nov 2024#116

Marking my place. If it changes for me I will come back and say so.

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coldchain_liuTL3Regular18 Nov 2024#117

One caution on EMA product information: everything above assumes the underlying documentation is what it claims to be. That assumption is doing real work and is rarely stated.

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m.nascimentoTL218 Nov 2024#118
s.leclerc, post #34: Answering the question post #32 raises rather than the one it answers. Summarising the EMA product information thread so far, since it is long and the answer is buried: the first reply has the method, the fourth has the correction to it, and the rest is people agreeing at length. Go to post

EMA is the regulator with national implementation. Licensed incretin analogues are prescription-only across the EU, with some variation in specific approvals by member state.

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AA
a.almeidaTL218 Nov 2024#119

Adding what did not work for me on EMA product information, since the failures never get written up and they are half the useful information.

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p.silvaTL218 Nov 2024#120

EMA product information has a well-known answer and a correct answer, and the interesting work is establishing that they are the same. Nobody has done that here yet.

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