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I wanted to know the following and any feed back from our EU
colleagues is highly appreciated.....
1. What is the acceptability status of Biopharmaceutical
Classification System in getting Biowaiver for generic Product
Approval Process by EMEA?
2. Is Former Soviet Block Countries and Eastern European Countries
give mutual recognition and approval for drugs that gained EMEA
approval as a generic in one country let us say UK?
3. How do we find a reference products for conducting BE studies in
EU? is an Orange Book equivalent is available on web?
Siva Rama Prasad Kambhampati, PhD
Section Head, Clinical Evaluation of Specialty Products
MDS Pharma Services
621 Rose Street
Lincoln, NE-68502 USA
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