Navigating Evolving EU Marketing Authorisation: Are You Ready for Tomorrow’s Compliance?

Understanding the Human Factor: QPs, RPs and i-SPOC

Every batch released into the EU supply chain is certified by a Qualified Person (QP) under a manufacturing license, while Responsible Persons (RP) authorised by Wholesale Distribution Authorisation safeguard compliant distribution. These roles ensure that “humans in the loop” remain central to supply integrity, essential in the expanding era of AI and globalization. Did you know there is also a human in the loop for marketing authorization management?

Under Regulation (EU) 2022/123, all MAHs must appoint an Industry Single Point of Contact (i-SPOC) to enable rapid communications with EMA for any centrally or nationally authorized medicine. Registration is conducted through EMA’s IRIS platform and must remain up to date for all relevant products in your portfolio.

What MAHs Must Know – And Do

The MAH is legally responsible for continuous compliance with EU legislation and EMA guidance, including:

• Maintaining product quality, safety, and efficacy.
• Conducting proactive pharmacovigilance and risk management.
• Keeping all medicinal product data current in EMA’s SPOR Product Management Services (PMS).
• Ensuring organizational details and product records are fully registered and updated in SPOR’s OMS module.

Governance, Visibility & Risk Mitigation

Governance failures have repeatedly surfaced during recent regulatory inspections – including insufficient management of variations, inadequate advertising controls, and weak evaluation of product quality reviews. To mitigate these risks, every MAH should ask:

• Are all responsibilities assigned and documented in technical agreements?
• Is your company regularly auditing SPOR data quality and keeping i-SPOC registration effective?
• Does your quality management system cover not only GMP/GDP but also specific MAH responsibilities – including lifecycle and post-marketing obligations?
• Is your knowledge management framework adequate to communicate and maintain a proactive and robust product life cycle management.

Forthcoming EMA regulations (including the new Pharma Package and the Critical Medicines Act) will further intensify scrutiny on product shortage prevention, supply chain transparency, and lifecycle oversight.

Shortage Reporting: New Obligations, Unified Data

In 2025, the launch of the European Shortages Monitoring Platform (ESMP) revolutionized how shortages are reported and managed. This platform integrates data from manufacturers and national authorities, allowing real-time, coordinated EU-level responses – and reducing your reporting workload. Adopting compliant, connected processes for shortage and lifecycle management is now a strategic necessity.

Outsourcing, Quality Oversight, and the MAH Portfolio

Inspections show that some MAH legal entities, especially those set up specifically for EU access, focus heavily on GDP but neglect holistic oversight of the entire marketing authorization lifecycle. Remember: If you outsource MAH responsibilities to a global quality system, every delegated activity must be documented and defensible. It’s vital to maintain a complete inventory of marketing authorizations and to manage each within the umbrella of your quality system.

MIAS Pharma: Your Partner in Compliance

The complexity of today’s regulatory environment makes expert, proactive support a crucial asset. At MIAS Pharma, our specialists are ready to support all aspects of EU marketing authorisation compliance:

• Quality Systems set-up for Falsified Medicine Directive, (FMD) obligations and ongoing management.
• QP/RP advisory services and training
• Supply chain and shortage mitigation strategies
• End-to-end inspection readiness