MAA Life cycle management

Marketing Authorization Application (MAA)

A Marketing Authorization Application (MAA) is a comprehensive document submitted by pharmaceutical companies to regulatory authorities to obtain approval for marketing and distributing a medicinal product. In the European Union the MAA is assessed by the European Medicines Agency, if applicable, or by the national Authority of a member state.

The MAA process is complex and requires careful preparation and attention to detail ensuring accuracy and quality in work.

The MAA consists of several modules, including:

1. 1. 1. Module 1: EU Administrative and Prescribing Information
      2. Module 2: High-Level Summaries
      3. Module 3: Quality Documentation
      4. Module 4: Non-Clinical Documentation
      5. Module5: Clinical Documentation

Depending on the nature of the medicinal product and the strategy of the applicant there are four procedures for filing an application:

• • • Centralized Procedure
    • National Procedure
    • Mutual Recognition Procedure
    • Decentralized Procedure

Post MAA Life Cycle Management/ Variations and Renewals

Maintaining a state-of-the art marketing authorization (MA) for medicinal products in Europe requires ongoing regulatory activities to ensure compliance with current requirements and to incorporate new information about the product.

Variations:

Variations are any changes made to an existing MA after its initial approval. These can include:

• • • Administrative changes
    • Quality changes
    • Safety and efficacy updates
    • Pharmacovigilance modifications

The European Commission Regulation (EC) No 1234/2008 classifies variations into different types:

• • • Type IAIN, Type IA, Type IB, Type II, Extensions of MA and Article 61(3) notifications

The classification determines the timeline and level of assessment required.

Renewals

Initial MAs in Europe are typically valid for five years. Key aspects of the renewal process include:

• • • Applications must be submitted at least nine months before expiry
    • Renewal applications undergo formal assessment
    • Once renewed, MAs are usually valid indefinitely
    • Authorities may require one additional five-year renewal in some cases

For centralized procedures, renewals are based on Article 14 of EC Regulation No. 726/2004