EMA Urges Variation Submissions By 30 November Before Holiday Closure

The European Medicines Agency is encouraging companies to submit the type I variations they want to make to their marketing authorizations by the end of this month.

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The EMA has set a deadline for submitting applications for variations (Shutterstock)

The European Medicines Agency has set a 30 November deadline for marketing authorization holders (MAHs) who wish to submit minor variations to their marketing authorizations (MAs) and want the EMA to get the ball rolling on these before it closes for the Christmas and new year holiday period.

Key Takeaways
  • Submitting type IA and type IA-IN variations for 2024 no later than 30 November will enable the European Medicines Agency to acknowledge the validity of...

It said that MAHs should submit type IA and type IA-IN variations for 2024 no later than the November deadline, as this would enable it to acknowledge the validity of...

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