[RegAffairs]RE: Certificate of Pharmaceutical Product

["Michael Anisfeld" <manisfeld@globepharm.org>]

The CoPP is issued by the European Pharmacopoeia, and to get the
certificate, you need to submit samples to them, and they will need to
inspect you for GMP compliance. The CoPP has nothing to do with FDA.

With Best Regards,
Michael H. Anisfeld
 
Globepharm Consulting
E-mail: manisfeld@globepharm.org