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RegisterRussia: Toxicity data required [Regulatives / Guidelines]
Dear Karthikeyan,
Absolutely right. Current draft allows to provide literature review only.
We are waiting for approval and first law enforcement practice because there could be some pitfalls.
to ALL:
Are new requirements in this draft (see above) closer to EMEA GL?
Best regards, Mittyri
❝ I understand that earlier we need to go for toxicity studies for generics and now the current draft tell to provide literature review of the product.
❝
❝ is my understanding is correct. Please correct me if i'm wrong. 
Absolutely right. Current draft allows to provide literature review only.
We are waiting for approval and first law enforcement practice because there could be some pitfalls.
to ALL:
Are new requirements in this draft (see above) closer to EMEA GL?
Best regards, Mittyri
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Russia Guidance – BE Karthikeyan 2013-09-02 05:55
![[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 requiredmittyri 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 2010 mittyri 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 requiredmittyri 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