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Registerrererence product marketed only in some members states [Design Issues]
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.
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
Pass or fail!
ElMaestro
Complete thread:
- Non-availability of reference product EU Sanjeith K 2016-02-26 09:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- rererence product marketed only in some members states Helmut 2016-02-26 12:24
- rererence product marketed only in some members states Sanjeith K 2016-02-27 06:56
- rererence product marketed only in some members states Sanjeith K 2016-03-09 12:07
- rererence product marketed only in some members statesElMaestro 2016-03-09 13:48
- rererence product marketed only in some members states shakeel.salam 2016-03-11 10:36
- rererence product marketed only in some members states Helmut 2016-02-26 12:24
Ing. Helmut Schütz