Reference product in bioequivalence [Regulatives / Guidelines]

posted by slebr – Belgium, 2020-11-04 10:02 (220 d 01:45 ago) – Posting: # 22055
Views: 613

Dear Helmut,

first of all, i hope that you are doing well in these trouble period!

we would like to perform a bioequivalence (in Europe) study with our test versus a European marketed reference.

As stated in the 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 on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, as amended."

The problem is that the " original" reference was withdrawn from the market ( the reason is not known but the generics are yet on the market so we suppose that was not a safety reason).

What is the solution?

a generics? But which one ( there are a plenty of them)?
a out of European marketed reference? but it's not authorised..

If you have a idea... we will take it!

Many thanks for your time!

Have a nice day


Complete thread:

 Admin contact
21,518 posts in 4,498 threads, 1,523 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Saturday 12:48 CEST (Europe/Vienna)

If I find 10,000 ways something won’t work, I haven’t failed.
I am not discouraged, because every wrong attempt discarded
is another step forward.    Thomas Alva Edison

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz