Bioequivalence and Bioavailability Forum • Swiss reference?

Swiss reference? [Design Issues]

posted by Ohlbe – France, 2012-01-28 23:31 (5248 d 10:50 ago) – Posting: # 8014
Views: 4,330

Dear Helmut,

❝ One of our studies was accepted with a Swiss reference.

❝ ... had to be provided to the BfArM where the protocol was approved in 2005.

Maybe you were lucky in 2005... But look at section 4.1.2. of the current EU guideline:

For Article 10(1) and 10(3) marketing authorisation applications reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted in the Union...

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

Strength selection Paresh 2012-01-27 06:47 [Design Issues]
- Strength selection Helmut 2012-01-27 16:07
  - Strength selection Paresh 2012-01-28 11:29
    - Strength selection Helmut 2012-01-28 14:27
      - Strength selection Ohlbe 2012-01-28 18:20
        
        Swiss reference? Helmut 2012-01-28 18:30
        
        Swiss reference?Ohlbe 2012-01-28 22:31
        
        EU reference! Helmut 2012-01-29 03:51