European Marketing Authorization Success: The Critical Role of Quality and Compliance

Entering the European market isn't just about gaining marketing authorization — it's about sustaining it. For life sciences companies, success hinges on a robust approach to quality and compliance, two pillars that ensure patient safety and regulatory confidence. To achieve seamless market entry and long-term growth, a thorough understanding of these elements is critical.

The Qualified Person: Gatekeeper to the EEA Market

A key figure in this process is the Qualified Person (QP). Under European law, a QP is mandatory for any company seeking to release medicinal products in the EEA and UK. The QP serves as the assurer of GMP compliance across your supply chain and holds legal responsibility for batch certification.

ProPharma's experienced QPs help sponsors navigate this landscape by:

• Providing QP Declarations to confirm GMP compliance at the point of regulatory submission.
• Certifying batches for commercial launch or clinical trial initiation, ensuring no delays to your timelines.
• Acting within our Manufacturer/Importer Authorisation (MIA) framework to release products across all EEA countries and the UK.

QP Declaration: Building Regulatory Confidence

A QP Declaration is more than a formality. It provides assurance to regulators that your supply chain meets EU/UK GMP standards. For commercial products, this covers active substance manufacturers. For investigational medicinal products (IMPs), it extends to ex-EU/UK manufacturing and testing sites, including starting materials like cell banks.

ProPharma conducts thorough on-site audits and leverages GMP certificates from recognized authorities to issue declarations that withstand regulatory scrutiny.

Batch Certification: The Final Critical Step

No batch can reach European patients without certification by a QP named on a MIA license. This certification step involves:

• Verifying GMP compliance.
• Confirming product quality and safety.
• Ensuring all regulatory requirements are fulfilled.

Certification for the EEA must occur after importation, within EEA territory by an EEA QP. A Responsible Person for Import (RPi) is required in the UK to release EEA QP-certified batches. A Qualified Person (QP) is required in the UK to certify batches imported from outside the EEA.

ProPharma's Quality & Compliance Solutions

With over two decades of experience, ProPharma delivers a complete quality and compliance solution that includes:

• Acting as your MAH and MIA Holder in the EU/UK.
• Providing named QPs for batch release.
• Implementing efficient and compliant Quality and Pharmacovigilance systems.
• Supporting GMP/GDP audits and regulatory inspections.

We combine global reach with local expertise to help you meet regulatory expectations across Europe.

The ProPharma Advantage

When quality and compliance are non-negotiable, ProPharma provides:

• A trusted partner for MAH responsibilities.
• Tailored guidance from regulatory submissions to post-market surveillance.
• Proven success in navigating complex country-specific requirements.

Ready for European Market Success?

Quality and compliance aren't just regulatory hurdles — they're the foundation of your reputation in Europe. With ProPharma as your partner, you gain the confidence of a seamless market entry and enduring compliance.