rererence product marketed only in some members states [Design Issues]

posted by ElMaestro  – Denmark, 2016-03-09 14:48 (3266 d 04:44 ago) – Posting: # 16079
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Hi Sanjeith K,

in your case I would lean on directive 2001/83 §10.2b if we are talking IR:
" ‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product (...) The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form."

- which means: try and find a immediate release tablet if you can.
If your formulation is the MR version then of course this is meaningless.

Forget about using a Canadian ref. in EU.

Pass or fail!
ElMaestro

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