Market Authorization Application, Generics, MAA Submissions, EU

Freyr helps generic medicinal product manufacturers in handling Market Authorization Application (MAA) submissions with Article 10(1) requirements to HAs in EU by all procedures such as National Procedure (NP), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) & Centralized Procedure (CP).
A medicinal product, which has the same qualitative and quantitative composition of ingredients, same pharmaceutical form as that of reference medicinal product (RMP) as per the Directive 2001/83/EC Article 10(2)(b) and exhibits bioequivalence with the RMP shall be considered as generic medicinal product. Market authorization holder (MAH) of generic medicinal product should follow the EU guideline Article 10(1) of Directive 2001/83/EC for the registration in European Economic Area (EEA).
The key advantage for the MAH is that they are not required to perform and include non-clinical and clinical studies in market authorization application (MAA) as safety and efficacy of the product has already been proved by innovator in their application. Since the MAH of generic medicinal product is same as RMP, in composition and formulation, only documents / data to prove the quality should be included in MAA. Additionally, the MAH will also need to submit bioequivalence of product with RMP to Health Authority (HA).
MAA for generic medicinal products can be submitted to HAs of EU member states by any of the following procedures:
Know more at Freyr Page - Market Authorization Application (MAA) submissions

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