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flipper44

02/22/23 12:23 PM

#569942 RE: hoffmann6383 #569749

The PR is trumped by the MHRA statement in their email to Lykiri. The MHRA statement on ability to file both MIA application and MIA application at the same time is clear. You can do it as long as you intend to produce that product in the relevant facility.

On the other hand, when the company is seeking an MA, in order to grant an MIA license, the product must be “in the process of being approved.”