EMA Explains Procedure For Parallel Review Of Drugs For EU And Non-EU Markets
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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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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