EMA product information as a primary source posts 61–75
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Coming back to post #60, because the follow-up matters more than the original answer.
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.
Happy to expand any of that if it is the useful part.
This is the sort of exchange that makes the archive worth searching.
Reporting rather than recommending, on EMA product information. What happened is above. Whether it should have is a different question and not one I am qualified to answer.
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.
It reads as pedantry until the day it does not.
Counterpoint on EMA product information, offered without confidence: the same observation is consistent with a much duller explanation, and nobody has ruled the dull one out.
Adding a reference point for EMA product information. Mine is a single case, collected without controls, and I am posting the method alongside it so it can be discounted appropriately.
Everything in post #68 holds. The case it does not cover is the one I have.
Prescription status is harmonised at the level of the authorisation and the practical route to a prescription is not.
Written quickly, so the reasoning may be tighter than the wording.
For anyone finding this later: the short answer on EMA product information is that it depends on one thing, and the rest of the thread is people identifying which thing.
EMA product information is one of those subjects where the general answer and the answer for a specific case diverge, and the thread will go in circles until someone says which one is being asked for.
Reimbursement is decided nationally and varies substantially between member states for the same authorised product.
Following, with nothing to contribute beyond having asked the same thing elsewhere.
This topic was referenced in
- Coming back to: Cross-border purchase rules within the EURegional › European Union · 16 replies
- EU-wide position versus national implementation — what changed sinceRegional › European Union · 26 replies
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