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Dear all,
Well... I've heard of some dossiers where the French Agency made it a clear condition when granting a marketing authorisation.
Regulators are not too happy with applicants who think a little too obviously that they are stupid
. If you run your BE with a batch of 50,000 tablets and claim this will be your full industrial batch size, then come with a variation to increase the size to 500,000 without a new BE, you can expect some difficulties.
❝ A new BE must not be mandatory.
Well... I've heard of some dossiers where the French Agency made it a clear condition when granting a marketing authorisation.
Regulators are not too happy with applicants who think a little too obviously that they are stupid
. If you run your BE with a batch of 50,000 tablets and claim this will be your full industrial batch size, then come with a variation to increase the size to 500,000 without a new BE, you can expect some difficulties.—
Regards
Ohlbe
Regards
Ohlbe
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 Variation Dr_Dan 2013-09-18 10:01
- Type II VariationOhlbe 2013-09-18 12:41
- Type II Variation Elena 2013-09-18 12:55
- Type II Variation Dr_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