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Dear all,
or, if we talk EU, perhaps article 10.3 of EC directive 2001/83 cold be considered:
In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.
or, if we talk EU, perhaps article 10.3 of EC directive 2001/83 cold be considered:
In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- BE Information Request A-M-R 2011-01-23 08:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Potency correction Jaime_R 2011-01-23 14:44
- The unknown EMA d_labes 2011-01-24 08:19
- The unknown EMA Jaime_R 2011-01-24 10:52
- The unknown EMAElMaestro 2011-01-24 13:22
- The unknown EMA d_labes 2011-01-24 08:19
- Potency correction Jaime_R 2011-01-23 14:44
Ing. Helmut Schütz