Bioequivalence and Bioavailability Forum • Reference Product decision

Reference Product decision [Regulatives / Guidelines]

posted by Tina – India, 2013-04-22 13:40 (4425 d 07:46 ago) – Posting: # 10452
Views: 7,274

Should a European Reference Product be always used for MRP/DCP? If the innovator is the European Reference Product and is not available in a member state, can the generic (which had compared itself with the ERP) available in the member state be used for MRP/DCP application with the member state as the RMS? If the generic is marketed only in one member state, it would have been the company's decision to market in that MS. However, they have still compared with the innovator?

Does EMA require only a innovator to be compared as the reference?

Thanks in advance for the guidance.

Complete thread:

Reference Product decisionTina 2013-04-22 11:40 [Regulatives / Guidelines]
- EEA: Reference Product Helmut 2013-04-22 13:09
  - Reference Product Tina 2013-09-24 14:08
    - Reference Product Helmut 2013-09-24 22:53
      - Reference Product Tina 2013-09-27 18:02
        
        Last time: R = innovator Helmut 2013-09-28 09:40
        Reference Product The Outlaw Torn 2013-09-30 08:18
        
        Reference Product Tina 2013-10-01 14:27
        
        Reference Product The Outlaw Torn 2013-10-02 08:03
        
        Reference Product Tina 2013-10-03 11:37