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EMA Offers Simultaneous Review Of Products For EU And Non-EU Markets

Move Will Reduce Time For Article 58 Opinion On Medicines To Be Also Used In EU

Executive Summary

Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.

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Companies can get the European Medicines Agency’s scientific opinion for their products’ use in EU and non-EU countries at about the same time.

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