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iMAH Model
A&O Pharma's Interim Marketing Authorisation Holder model explained concisely.
The Interim Marketing Authorisation Holder model is aimed at manufacturers without their own registration unit in the EU. A&O Pharma applies for the marketing authorisation and acts temporarily as the marketing authorisation holder itself, until the authorisation is transferred to a commercial partner of your choice.
The document explains the two-stage approach: first, 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, Graduated Plan Officer (Stufenplanbeauftragte) or QPPV under § 63a AMG, Qualified Person under § 14 AMG and Information Officer under § 74a AMG.
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