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Will any regulatory agency accept the BA/BE study report, which was done two years before?
How long the BE study report is valid?
Is there any guidelines says about validity of the BE study report?
Thanks in advance.
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That's tricky question without "passe-partout" answer. The valid answer depends on local drug legislation and whether the particular state is accepting in its drug legislation the concept of data exclusivity.
As to EU MS:
"Under Directive 2001/83/EC, EU data exclusivity laws guaranteed market protection for originator medicines for either 6 or 10 years.The effective period of market exclusivity gained by the originator company is the period of data exclusivity (currently 6 or 10 years) plus the time it takes to register and market the generic medicine -- a further 1 to 3 years.
The New EU Pharmaceutical Legislation adopted in 2004 has created a harmonised EU eight-year data exclusivity provision with an additional two-year market exclusivity provision. This effective 10-year market exclusivity can be extended by an additional one year maximum if,..." .
For more detailed explanations you can visit EGA Home page at www.egagenerics.com.
Dimiter Terziivanov, MD,PhD,DSc, Professor
Pharmacology and Clinical Pharmacology
SOFIA UNIVERSITY "ST. KLIMENT OHRIDSKI"
FACULTY OF MEDICINE
1 Koziak str.
1407 Sofia, BULGARIA
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