Elite Pharmaceuticals Inc (ELTP): Elite would have to get an euro approval...

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Elite Pharmaceuticals Inc (ELTP)

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Re: HGilS post# 363268

Sunday, 12/12/2021 11:49:44 AM

Sunday, December 12, 2021 11:49:44 AM

Elite would have to get an euro approval to sell in Europe

Timeline: EMA opinion on generics issued within 210 days, and submitted to European Commission for final approval.

Approval by EMA takes place by using a centralized procedure that leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway.

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