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iMAH Model: Interim MAH for the EU
How A&O Pharma acts as interim marketing authorisation holder (iMAH) in the EU until the authorisation is transferred to your partner.
The interim marketing authorisation holder (iMAH) model is aimed at manufacturers without their own regulatory presence in the EU. A&O Pharma applies for the marketing authorisation and acts as the marketing authorisation holder itself for a transitional period, until the authorisation is transferred to a commercial partner of your choice.
The document explains the two-stage approach: first, the joint development of the regulatory strategy, then registration and marketing authorisation applications (MAA), in which A&O Pharma acts as applicant and subsequently as interim marketing authorisation holder. During the procedure, we can also provide the legally required functions: Stufenplanbeauftragter (German QPPV) under § 63a AMG, Qualified Person under § 14 AMG and Information Officer under § 74a AMG.
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