09. Will I receive an approval letter from IMA for national authorisations (pure nationals, MR, DC) included in a worksharing application, with at least one centralised marketing authorisation (EMA is the reference authority) and the changes do not affect the product information?

No, IMA will not issue approval letters for national authorisations in these cases. Changes, not affecting the product information, can be considered approved by IMA, at time of opinion from EMA (CHMP Opinion). When worksharing procedures affect the product information, applicants should submit updated texts to IMA at [email protected] at end of procedure.

The texts/translations should be submitted in Word format (highlighted and clean versions).

Last updated: December 17, 2021
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