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RegisterType II Variation [Regulatives / Guidelines]
Dear Elena
AFAIK if you conduct the BE study with a production scale batch of less than 100.000 then you will get a marketing authorisation for your product with a production scale of less than 100.000. Afterwards you can scale up up to 10 fold with a variation. The kind of variation (type Ia/b, II) depends on the complexity of the production and scale up process. A new BE must not be mandatory.
Kind regards
Dan
AFAIK if you conduct the BE study with a production scale batch of less than 100.000 then you will get a marketing authorisation for your product with a production scale of less than 100.000. Afterwards you can scale up up to 10 fold with a variation. The kind of variation (type Ia/b, II) depends on the complexity of the production and scale up process. A new BE must not be mandatory.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- biobatch size and scale up Elena 2013-09-17 10:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Type II Variation Helmut 2013-09-17 16:36
- Type II Variation Elena 2013-09-18 08:42
- Type II VariationDr_Dan 2013-09-18 10:01
- Type II Variation Ohlbe 2013-09-18 12:41
- Type II Variation Elena 2013-09-18 12:55
- Type II VariationDr_Dan 2013-09-18 10:01
- Type II Variation Elena 2013-09-18 08:42
- Type II Variation Helmut 2013-09-17 16:36
Ing. Helmut Schütz