Reclaiming the European Market: How to Secure EU/UK MAH Status Without the Local Infrastructure

For many US and APAC pharmaceutical companies, reacquiring the European rights to a successful, out-licensed product is a smart strategic move — an opportunity to capture greater margins, regain control over brand strategy, and re-establish direct oversight of market performance.

However, this ambition often meets an immediate and complex regulatory challenge: to place the product back on the European market, a legal entity serving as the Marketing Authorisation Holder (MAH) must be in place for both the EU and the UK. Without an existing European entity or established compliance infrastructure, this requirement can delay or even derail the license reacquisition process.

This blog explores why the MAH function is essential — and how partnering with a specialized provider offers a compliant, rapid, and low-risk pathway to full operational control in Europe.

The Motivation and the Gap: The Business Context

Why Companies Reacquire Licenses

In recent years, many biopharma innovators have chosen to reacquire rights to their own out-licensed products across Europe. The motivations are clear:

• Revenue and margin optimization – capturing the full commercial value of proven products.
• Strategic control – aligning pricing, commercialization, and lifecycle management with global brand objectives.
• Evolving partnerships – responding to underperforming licensees or shifting corporate strategies.

Yet, once reacquisition begins, a crucial realization surfaces: the product cannot be placed on the market until an entity serving as the authorized MAH is established locally or at a European level.

The Regulatory “MAH Gap”

The Marketing Authorisation Holder is not a formality — it’s the legally responsible entity for ensuring product safety, efficacy, and quality across its lifecycle.

Many US and APAC companies reacquiring rights lack:

• A European legal entity recognized by EMA or MHRA.
• A quality management system (QMS) compliant with EU and UK standards.
• In-house pharmacovigilance (PV) and regulatory affairs teams in-region.

And crucially, the MAH cannot be a “post-box” or nominal address — it carries active, ongoing responsibilities, including maintaining PV systems, managing regulatory filings, and ensuring quality compliance.

Core MAH Responsibilities: The Non-Negotiables

Securing MAH status isn’t just about holding a license; it’s about meeting continuous, audited obligations. These include:

Pharmacovigilance (PV) and Safety

• Maintaining the EU/UK PV System Master File (PSMF).
• Appointing a qualified Qualified Person for Pharmacovigilance (QPPV) and local PV representatives (LPPVs), as applicable.
• Conducting ongoing signal detection, safety reporting, and risk management activities.

Regulatory Compliance & Lifecycle Management

• Managing the SmPC, labeling, and Patient Information Leaflet (PIL).
• Executing variations, renewals, and submissions with EMA and national authorities.
• Acting as the primary contact for the EMA, MHRA and EU NCAs.

Quality Assurance (QA) and QP Services

• Ensuring compliant batch release via an EU/UK Qualified Person (QP).
• Maintaining the integrity of the product's quality system linked to the license.

These functions form the foundation of post-authorization compliance — and failure to meet them can result in regulatory findings, fines, or suspension of market access.

Operationalizing the Partnership: Execution & Benefits

Seamless Transfer Process

Our MAH transition process is structured for efficiency and regulatory confidence:

1. Coordination of license transfer documentation with the competent authorities.
2. Immediate onboarding of the product into ProPharma's PV and RA systems.
3. Full handover of safety, quality, and regulatory responsibilities — ensuring zero compliance downtime.

Financial and Strategic Benefits

• Cost-Effective Structure – Avoids the multi-million-dollar investment and multi-year timeline of building a European regulatory entity.
• Operational Focus – Allows the parent company to concentrate resources on commercialization, market access, and brand strategy while our experts manage ongoing regulatory maintenance.

The Strategic Pathway to Reclaiming Your License

Reacquiring a European license is a bold and lucrative strategic move — but without a compliant MAH infrastructure, it can quickly become a regulatory roadblock.

By leveraging a third-party MAH partner like ProPharma, US, APAC, CAN, and LATAM companies can reclaim control of their product, maintain full compliance, and accelerate time to market without the burden of building a new European operation from scratch.

If your organization is planning a license buyback or facing an urgent MAH transition in the EU or UK, connect with a ProPharma specialist today to learn how we can become your compliant, legal MAH partner and help you reclaim your license with confidence.