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flipper44

02/22/23 1:26 PM

#569969 RE: FeMike #569963

Sigh. They are independent of each other in terms of internal process, however, if one is seeking an MA for a product, there must be an MIA license before an MA is granted; and, in order to obtain an MIA license, the product must already be “in the process of being approved.” That’s MHRA guidance. On the other hand, an MAA (application) and MIA application can be filed at the same time so long as there is intent to produce the product at the facility in which the MIA is being sought. The latter is MHRA’s position in an email response to Lykiri.