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Register# 61–FZ adopted 24 March 2010 [Regulatives / Guidelines]
Dear Karthikeyan,
Helmut replies to you absolutely correct:
At this moment
❝ i just want make sure the toxicity data is not required for generics from this law.
Helmut replies to you absolutely correct:
At this moment
❝ You need toxicity data of the formulations (test + reference!) – not only of the API – before you start a BE study. The idea behind is a complete mystery to me. Anyhow, according to federal law #61 (aka “Lex Putin”) BE studies have to be performed by Russians CROs only. AFAIK, no way to do it in India.
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Russia Guidance – BE Karthikeyan 2013-09-02 05:55 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Russia Guidance – BE drgunasakaran1 2013-09-02 06:14
- Russia Guidance – BE Karthikeyan 2013-09-02 06:21
- Russia: Toxicity data required Helmut 2013-09-02 10:31
- Russia: Toxicity data required mittyri 2013-09-02 14:18
- Russia: Toxicity data required Karthikeyan 2013-09-03 08:48
- Russia: Toxicity data required mittyri 2013-09-03 09:26
- Toxicity data: why? Helmut 2013-09-03 13:02
- Russia: Toxicity data required Karthikeyan 2013-09-04 06:46
- Russia: Toxicity data required mittyri 2013-09-04 08:58
- Federal Law # 61–FZ “On circulation of drugs” Helmut 2013-09-05 00:09
- Federal Law # 61–FZ “On circulation of drugs” Karthikeyan 2013-09-05 13:52
- # 61–FZ adopted 24 March 2010 Helmut 2013-09-05 15:21
- # 61–FZ adopted 24 March 2010 Karthikeyan 2013-09-06 06:32
- # 61–FZ adopted 24 March 2010mittyri 2013-09-06 07:22
- # 61–FZ adopted 24 March 2010 Karthikeyan 2013-09-06 06:32
- # 61–FZ adopted 24 March 2010 Helmut 2013-09-05 15:21
- Federal Law # 61–FZ “On circulation of drugs” Karthikeyan 2013-09-05 13:52
- Federal Law # 61–FZ “On circulation of drugs” Helmut 2013-09-05 00:09
- Russia: Toxicity data required mittyri 2013-09-04 08:58
- Russia: Toxicity data required mittyri 2013-09-03 09:26
- Russia: Toxicity data required Karthikeyan 2013-09-03 08:48
- Russia: Toxicity data required mittyri 2013-09-02 14:18
- Russia: Toxicity data required Helmut 2013-09-02 10:31
- Russia Guidance – BE Karthikeyan 2013-09-02 06:21
- Russia Guidance – BE Dr_Dan 2013-09-03 14:40
- Russia Guidance – BE Helmut 2013-09-03 14:45
- Russia Guidance – BE Dr_Dan 2013-09-03 19:27
- ги́бкость Helmut 2013-09-03 21:16
- Flexibility Dr_Dan 2013-09-04 10:20
- Cultural ∆ Helmut 2013-09-04 14:30
- Flexibility Dr_Dan 2013-09-04 10:20
- Russia Guidance – BE mittyri 2013-09-04 09:15
- ги́бкость Helmut 2013-09-03 21:16
- Russia Guidance – BE Dr_Dan 2013-09-03 19:27
- Russia Guidance – BE Helmut 2013-09-03 14:45
- Russia Guidance – BE drgunasakaran1 2013-09-02 06:14
Ing. Helmut Schütz