Bioequivalence and Bioavailability Forum • Federal Law # 61

Federal Law # 61–FZ “On circulation of drugs” [Regulatives / Guidelines]

posted by Karthikeyan – India, 2013-09-05 15:52 (4681 d 23:58 ago) – Posting: # 11442
Views: 11,875

Dear Miityri & Helmut,

Thank for the link and got the english version.

http://acto-russia.org/en/index.php?option=com_content&task=view&id=7

As per page no. 20/67 & 37/67, the law tells,

"Generic medicinal products intended for medical use are subject to trials for bioequivalence and/or therapeutic equivalence in the procedure established by the authorized federal executive body"

Please confirm it is in draft stage or it is published.

Sorry for troubling more and thanks for the help.

Regards,

Karthikeyan

Complete thread:

Russia Guidance – BE Karthikeyan 2013-09-02 05:55
- 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 2010 mittyri 2013-09-06 07:22
- 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
      - Russia Guidance – BE mittyri 2013-09-04 09:15