slebr
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Belgium,
2020-11-04 10:02
(602 d 06:13 ago)

Posting: # 22055
Views: 831
 

 Reference product in bioequivalence [Regulatives / Guidelines]

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The problem is that the " original" reference was withdrawn from the market ( the reason is not known but the generics are yet on the market so we suppose that was not a safety reason).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

Sonia
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