Spring Intro 2023

16/02/2023

Considerations & Tips

• Subject to Specific Obligations to provide comprehensive data confirming that the benefit-risk balance is positive • Authorisation valid for one year, renewed annually thereafter • Application for standard MA can be submitted once comprehensive data is available • NOTE : When “full” MAA is granted renewal cycle is reset – a full renewal needs to be submitted 5 years after the grant of the full MAA

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RENEWALS

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