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Regional · European Union · continued

EMA product information as a primary source — does this still hold? posts 121–150

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.

NK
n.kuuselaTL218 Nov 2024#121
j.sorensen, post #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… Go to post

Confirming post #120 from a second method, which matters more than confirming it from a second person.

Regional stock held inside the union removes a customs question entirely for intra-union movement, which is a practical difference rather than a legal opinion.

That is one dataset and I would not build a rule on it.

0 likes in reply to #96 20mo
NA
n.abernathyTL3Analytical chemist18 Nov 2024#122

Worth stating the null on EMA product information before we explain it: the observation may be nothing. That possibility deserves a sentence and usually does not get one.

0 likes 20mo
HA
h.agyemanTL218 Nov 2024#123
DH
dietitian_hollisTL3Dietitian18 Nov 2024 · edited#124

Correcting a stale claim here is more valuable than adding a new one, because the stale claims are what people find first.

I would be glad to be shown a cleaner way of putting this.

12 likes 20mo
EH
e.halonenTL218 Nov 2024#125
a.finnegan_rd, post #87: This is the answer, and the reason it is the answer is the more useful part. Go to post

Post #124 is right about the mechanism and I think understates the practical bit.

Reimbursement is decided nationally and varies substantially between member states for the same authorised product.

On reflection I would soften that slightly.

0 likes in reply to #87 20mo
JW
journalclub_wrenTL3Regular18 Nov 2024#126

Coming back to post #122, because the follow-up matters more than the original answer.

Second-hand on EMA product information, so weight it accordingly — someone whose method I trust told me this and I have not verified it myself.

1 like 20mo
YA
y.asanteTL218 Nov 2024#127

The bit of EMA product information that nobody enjoys is that the answer changes depending on what you are trying to decide with it. Say what the decision is and the thread will converge.

7 likes 20mo
SS
steady_stateTL3Regular18 Nov 2024#128

Grateful for the specificity. Vague answers to this question are what sent me looking.

17 likes 20mo
SV
s.vukovicTL218 Nov 2024#129
j.castellanos, post #76: Where I part company with post #72, and it is a narrow parting. The arithmetic on EMA product information is the easy part and it is where the errors are, which is an uncomfortable combination. Show your working and someone will catch it. Go to post

Reading rather than answering, but this is the post I would point somebody at.

0 likes in reply to #76 20mo
NE
n.ekstromTL2Regular18 Nov 2024#130

Language versions of the product information are all official and occasionally differ in emphasis. Where a detail matters, reading two is not paranoid.

That is the practical version. The rigorous version is longer and says the same thing.

3 likes 20mo
AK
a.krastevTL218 Nov 2024#131

I read post #130 twice before replying, because I had assumed the opposite.

Nobody has said the unglamorous part of EMA product information yet, so: most of the variation is explained by things that are boring to write about and easy to check.

23 likes 20mo
AL
aliquot_lineTL3Regular18 Nov 2024 · edited#132

My experience of EMA product information contradicts the reply above. I am posting it as a data point rather than as a refutation, because one person's experience is exactly that.

11 likes 20mo
EN
e.nilsenTL218 Nov 2024#133

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

Worth checking against a second source before it gets quoted onward.

3 likes 20mo
KB
k.brandl_deTL3Translator · DE18 Nov 2024#134
p.silva, post #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. Go to post

Reading back through the EMA product information threads from last year, the same three questions come up every time and only one of them has ever been answered properly. That seems like a documentation gap rather than a knowledge gap.

0 likes in reply to #120 20mo
LK
l.krastevTL218 Nov 2024#135
n.chowdhury, post #105: No disagreement from me. Posting only so the question does not look ignored. Go to post

Coming back to post #133, because the follow-up matters more than the original answer.

EMA product information is well covered in the tag pages, and the older discussions are better than the recent ones because they were argued out properly. Worth twenty minutes before adding to this one.

31 likes in reply to #105 20mo
GD
glossary_deskTL3Regular18 Nov 2024#136

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

Two sources, same conclusion, and I could not rule out that one copied the other.

16 likes 20mo
AV
a.vestergaardTL218 Nov 2024#137

The reason EMA product information keeps being re-asked is that the answer is conditional and people quote it without the condition. It is not that the answer is unknown.

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GEldridgeTL3Regular18 Nov 2024#138

Taking EMA product information seriously for a moment rather than deflecting: the honest position is that the community has observations and no controlled comparison, and those two things support very different sentences.

1 like 20mo
GD
g.danquahTL218 Nov 2024 · edited#139
a.finnegan_rd, post #64: Taking post #63 at face value and following it one step further. The confident answers on EMA product information and the well-sourced answers are not the same answers, which is the most useful thing I have learned reading this category. Go to post

Members outside the union should note that essentially none of this transfers, including the parts phrased generally.

I would want to see it done twice before believing it once.

0 likes in reply to #64 20mo
SS
s.stavrianosTL2Member18 Nov 2024#140

Confirming post #137 from a second method, which matters more than confirming it from a second person.

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.

22 likes 20mo
AL
a.lindqvistTL218 Nov 2024 · edited#141

Two things can be true about EMA product information at once: the mechanism is plausible and the evidence for the size of the effect is thin. Most of the argument here is people defending the first against attacks on the second.

30 likes 20mo
JV
j.vandermolenTL3Regular18 Nov 2024#142

Before the thread moves on from EMA product information — what is the sample size behind the claim? I am not being difficult; I have seen the same figure quoted from an n of four and from an n of four hundred.

0 likes 20mo
SD
st.dialloTL219 Nov 2024#143
b.vestergaard, post #41: I would be cautious about generalising from the EMA product information example above. It is a good example. It is one example. Go to post

Building on post #142 rather than restating it.

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

This is where my knowledge stops and I would rather mark the edge than blur it.

6 likes in reply to #41 20mo
GV
g.valckenaereTL3Regular19 Nov 2024#144

Seconded. It reads as careful rather than confident, which is the right register.

15 likes 20mo
CS
c.serranoTL219 Nov 2024#145

Marking my uncertainty on EMA product information explicitly. I am confident about the direction, much less confident about the size, and not confident at all that it generalises past the case in the first post.

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BBramleyTL3Regular19 Nov 2024#146
s.kuusela, post #25: Nothing here is medical or legal advice, and this subcategory in particular attracts questions where that matters. I am reporting what happened, not recommending it. Go to post

Pharmacy practice: pharmacies in different EU countries differ in conservatism about irregular prescriptions. Some will decline a prescription they consider irregular; others will not. Local pharmacy culture matters.

That is a description of practice, not a recommendation of it.

0 likes in reply to #25 20mo
IA
i.amankwahTL219 Nov 2024#147

Post #146 is the version of this I will quote in future. One addition.

Reimbursement is decided nationally and varies substantially between member states for the same authorised product.

Adding a source would improve this post and I do not have one to hand.

3 likes 20mo
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t.nardoneTL3Regular19 Nov 2024#148

If someone has run EMA product information properly I would rather read that than my own reconstruction of it. Posting mine only because the thread has gone quiet.

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EM
e.mensaTL219 Nov 2024#149

Appreciated. The plain phrasing does more work here than a longer post would.

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HRouhaniTL1Member19 Nov 2024#150

Agreed on EMA product information, with one qualification that I think matters. The reasoning holds for the case as described. Change the starting assumption and it does not, and the starting assumption is the part nobody states.

2 likes 20mo