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RegisterType II Variation [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2013-09-17 18:36 (4662 d 14:21 ago) – Posting: # 11508
Views: 6,522
Hi Elena,
Do I get you right – you got the approval with a production batch which is <100,000 units and want to scale up? IMHO, this is a “Major Variation of Type II” as defined in 1234/2008/EC Article 2(3), which
❝ If the biobatch is < 100,000 units, is scale-up allowed according to EU regulations?
Do I get you right – you got the approval with a production batch which is <100,000 units and want to scale up? IMHO, this is a “Major Variation of Type II” as defined in 1234/2008/EC Article 2(3), which
[…] means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned.
If waiving criteria of the GL are not fulfilled, I would say you need another BE study.—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 VariationHelmut 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 Variation Ohlbe 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 VariationHelmut 2013-09-17 16:36
Ing. Helmut Schütz