No chance against RMS? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2010-08-10 16:26 (4178 d 11:18 ago) – Posting: # 5765
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Dear Dan,

Under the first point I think I would add that you have not (have you?) received questions for module 3 and specifications; thus, the potential variability from the studies reflects -at least in part- the natural variation within the specifications that the M3 assessor has accepted.

You are right, a referral will not be triggered if the RMS disagrees. This is a new thing and there is very little you can do. If the RMS enforces a principle that has never been defined in a guideline document and which is not in line with contemporary equivalence thinking then honestly I think this would be a case for the European Generics Association. This is a slow process and not one that can be expected to work here and now.
Having said that, I am pretty sure regulators from BfArM are seeing this thread and giving it some consideration. That would potentially be in your favour.

I actually still believe your product is alive.

Pass or fail!

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