Regulatory compliance demystified: In-depth examination of MAH regulations in Central & Eastern Europe.

The project empowered the client with a clear roadmap for MAH operations, enabling efficient market entry, regulatory compliance, and strategic positioning in the pharmaceutical market.

Outcome

  • Analysis of the MAH process flow, including registration, licensing, and compliance requirements, enabling streamlined operations and regulatory adherence.
  • Actionable insights on local presence needs, partnerships, and transfer pricing strategies to enhance market entry and positioning.
  • Roadmap for managing MAH responsibilities, from registration to post-market activities, ensuring efficiency and regulatory compliance.

KEY INTELLIGENCE OBJECTIVES

  • Define the role of the Marketing Authorization Holder (MAH), including its responsibilities and significance in pharmaceutical product registration and lifecycle management.
  • Analyze the sales and registration process, detailing involved authorities, required documentation, timelines, costs, and stakeholder roles.
  • Map the steps for obtaining a pharmaceutical product registration certificate, including initial and post-registration expertise, duration, costs, and compliance requirements.
  • Examine licensing requirements and import regulations, focusing on pharmaceutical activity permits, quality standards, exceptions, and associated costs.
  • Explore local presence requirements and partnerships, highlighting infrastructure needs, local recognition, and collaboration opportunities for regulatory compliance.
  • Assess the role of the Qualified Person (QP) in maintaining quality standards and ensuring compliance with pharmaceutical regulations.
  • Investigate transfer pricing strategies and their implications, considering local taxation, market conditions, and pricing compliance.
  • Detail the current MAH process flow, from registration to market entry and post-market activities, emphasizing license renewal, brand recognition, and operational efficiency.

Geography

  • Western Europe
  • Central & Eastern Europe
  • Middle East
  • Africa
  • North America
  • South America
  • Other

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