Your MAH Partner in Europe and UK

Operating as a Marketing Authorisation Holder (MAH) in Europe and the UK is a nuanced and highly regulated role. Far beyond simply holding a marketing authorisation, MAHs must navigate a complex web of compliance, regulatory obligations, pharmacovigilance, and commercial oversight to ensure medicinal products remain on the market while safeguarding patient safety.

Establishing the MAH Infrastructure

Before an MAH can operate, it must build a robust infrastructure. Setting up a legal entity within the European Union, securing liability insurance, and managing financial requirements – including fees for marketing authorisation maintenance and pharmacovigilance – are critical first steps. Additionally, serialisation compliance per the Falsified Medicines Directive (2011/62/EU) mandates registration with European and national verification systems, reinforcing the integrity of the pharmaceutical supply chain.

Regulatory Complexity: Ensuring Compliance

Maintaining medicinal product authorisations requires meticulous regulatory management. From planning lifecycle submissions to navigating fees, publishing eCTDs, and handling artwork reviews, the MAH must remain compliant with national and European legislative changes. A proactive approach is necessary to ensure successful submissions, accurate translations, and alignment with evolving guidance.

Quality & Pharmacovigilance: Safeguarding Patient Safety

A Marketing Authorisation Holder (MAH) plays a crucial role in maintaining product quality, regulatory compliance, and patient safety. A well-structured pharmacovigilance system ensures that adverse events, safety signals, and risk minimisation measures are diligently captured, assessed, and reported, meeting strict regulatory requirements.

Meanwhile, the Quality Management System (QMS) provides oversight across critical functions, including supplier qualification, audits, deviations, recalls, and batch release. Additionally, Annual Product Quality Reviews (PQRs) offer a structured approach to monitoring product consistency, identifying trends, and ensuring ongoing compliance with regulatory standards—all essential for maintaining market integrity, public trust, and product safety.

Commercial Oversight: Ethical Compliance

Marketing compliance is a fundamental obligation of the MAH, ensuring promotional activities, healthcare professional (HCP) interactions, and sample distribution adhere to strict regulatory standards. From advertising approvals to ethical engagements with HCPs, the MAH must navigate industry codes and legal frameworks to uphold transparency and trust in the industry.

The Challenge: Expertise & Strategic Execution

For many pharmaceutical companies, navigating the role of a Marketing Authorisation Holder (MAH) is a formidable challenge. The regulatory requirements demand specialist expertise and robust infrastructure, which many organisations simply do not have in-house.

Building these capabilities independently can drain time, resources, and focus from a company’s core priorities – commercialising assets and driving market growth. Establishing compliance functions, understanding evolving legislation, and managing regulatory processes internally not only introduces complexity and risk but also slows down product expansion and revenue generation.

Rather than investing heavily in infrastructure and technical expertise, companies can seamlessly plug into Integral Pharma Solutions – a one-stop-shop solution designed to remove barriers to growth. We provide end-to-end support, enabling pharmaceutical companies to stay compliant, operate efficiently, and focus on accelerating their market success. By leveraging our specialist knowledge, proven systems, and regulatory insight, companies can reduce costs, mitigate risks, and commercialise their assets with confidence.

At Integral Pharma Solutions, we empower companies to scale efficiently and maximise commercial potential. Let us handle the complexities, so you can focus on growing your business – contact us today!