MAA Registration

Overview

Registration of a Marketing Authorization Application (MAA) for a medicinal product will provide access to all the EU member states for Marketing Authorization Holders (MAHs) or pharmaceutical manufacturers to manufacture and distribute.

Though the harmonized Regulatory requirements by all the EU member states eases the development and documents generation activity for pharmaceutical manufacturers, the complexity of the procedural requirements will need a Regulatory expert with complete understanding on the EU country-specific requirements, expertise in Health Authority interactions, and MAA registration activities (MAA submissions) to avoid validation rejections and major clock-stops that will delay the marketing authorization approval process.

In the generic drug approval process, the manufacturer or the sponsor of a generic medicinal product should select a specific MAA procedure such as the Centralized Procedure (CP), National Procedure (NP), Mutual Recognition Procedure (MRP), and Decentralized Procedure (DCP) for registration and placing the medicinal product in the EU.

Freyr, having established offices in multiple EU countries, can be a cost-effective and trust-worthy Regulatory partner for pharmaceutical manufacturers to handle the generic drug approval process including legal and administrative requirements, along with MAA registration support for the medicinal products through Article 8(3) (for innovator products) and Article 10(1) routes (for generic medicinal products). Freyr assures the pharmaceutical manufacturers and/or MAHs on legal and procedural compliance for registration and distribution of their products in the EU countries.