Marketing Authorisation Holder Responsibilities: A Practical Guide for New Entrants

Obtaining a marketing authorisation is an important milestone, but it is only the beginning of the MAH’s role. Once granted, the MAH is legally accountable for ensuring that the authorised product is manufactured, distributed, and monitored in accordance with EU legislation and national requirements. For new MAHs, the scope of obligations can be challenging to navigate. This guide outlines the core responsibilities across key domains and provides commentary on regulatory expectations, inspection trends, and best practices.

Regulatory Affairs

Core responsibilities:

• Comply with the content and conditions of the marketing authorisation; file and obtain approval for variations before implementation.
• Notify competent authorities of launch, as well as any suspension or withdrawal of the product.
• Submit renewal applications at least nine months before expiry, with a consolidated dossier covering all changes since approval.
• Pay applicable fees, including renewals, variations, and annual fees.
• Maintain local Agencies’ portals as well as National Compendia’s (where applicable).
• Essure Artwork compliance.
• Regulatory intelligence monitoring.

Regulatory affairs obligations form the backbone of MAH responsibilities. Authorities expect MAHs to maintain the integrity of the marketing authorisation dossier across the entire lifecycle of the product. Every change – whether related to quality, manufacturing, or product information – must be filed as a variation and approved before implementation. Renewal submissions must present a consolidated, consistent account of all variations and relevant data since approval. Inspectors frequently identify late or incomplete variation filings, gaps in renewal documentation, or failures to notify authorities about market launches and cessations. To meet expectations, MAHs should maintain a regulatory calendar covering deadlines for renewals, fees, periodic reports, and notifications, commitments supported by an electronic document management system with version control. Careful planning and strict documentation ensure that the MA remains valid, traceable, and inspection ready. Finally, companies must implement robust processes to continuously monitor changes in the legislative environment. Staying informed of evolving regulatory requirements is essential to ensure that all activities remain compliant with current laws and guidance. Proactive surveillance and timely adaptation are key to maintaining operational integrity and avoiding compliance risks.

Manufacturing & Quality (including shortages)

Core responsibilities:

• Maintain written agreements with manufacturers and batch release sites, ensuring compliance with GMP and the marketing authorisation dossier.
• Ensure that finished product controls are carried out as authorised.
• Notify authorities of scientific or technical progress requiring changes to the authorisation.
• Undergo inspections of manufacturing sites upon request.
• Ensure batch release is certified by a Qualified Person (QP) established in the EU/EEA.
• Provide scientific service for product information when required.
• Notify authorities of supply interruptions or shortages in accordance with national or EU requirements.
• Ensure annual PQR (Product Quality Report) review

Although manufacturing is often outsourced, the MAH remains responsible for ensuring that all operations are GMP compliant and consistent with the marketing authorisation. EMA guidance makes clear that responsibility cannot be transferred to the manufacturer. Written technical agreements must define roles, responsibilities, and reporting timelines, particularly for changes and deviations. Inspectors frequently note unapproved changes introduced because the MAH was not notified early enough, or insufficient review of Product Quality Reviews and deviation reports. The role of the QP is central: each batch must be certified against both GMP and the authorised dossier, with full documentation of decisions. In addition, MAHs must monitor supply continuity and report shortages promptly to competent authorities. Failure to notify or to provide accurate information on supply issues has become a common inspection finding. To avoid deficiencies, MAHs should implement robust agreements, conduct regular audits of manufacturing sites, ensure QP decisions are documented and defensible, and establish internal monitoring processes for shortages.

Distribution

Core responsibilities:

• Ensure wholesale distribution is carried out only by authorised WDA(H) holders or by manufacturers/importers with valid MIA.
• Maintain agreements with distributors covering recalls, complaints, product placement, and pharmacovigilance reporting.
• Notify authorities when importing products from another Member State.

Distribution activities must comply with Good Distribution Practice (GDP), and the MAH is responsible for ensuring that the supply chain operates accordingly. Authorities expect written distribution agreements that cover not only commercial aspects but also regulatory duties such as recall coordination, complaint handling, and pharmacovigilance reporting. Inspection findings often highlight missing or incomplete agreements, unclear responsibilities in recall procedures, or insufficient oversight of GDP compliance. In some cases, distributors fail to forward safety information promptly to the pharmacovigilance system, resulting in late case reporting. MAHs should therefore verify distributors’ authorisations, audit GDP compliance before engagement, and periodically test recall systems through drills. Regular communication with distributors helps ensure that responsibilities are understood and that obligations under GDP and pharmacovigilance are consistently met.

Pharmacovigilance

Core responsibilities:

• Maintain a pharmacovigilance system, including a Pharmacovigilance System Master File (PSMF).
• Appoint a Qualified Person for Pharmacovigilance (QPPV), permanently available and based in the EU/EEA.
• Collect, record, and report adverse reactions within regulatory timelines.
• Operate a risk management system for each product.
• Communicate safety information to the public when required.
• Conduct regular audits of the pharmacovigilance system and implement corrective actions.

Pharmacovigilance responsibilities are central to patient safety and among the most scrutinised areas during inspections. Authorities expect the MAH to have a fully documented and functional PV system, with the PSMF kept accurate and up to date. The QPPV must be integrated into the organisation, empowered to oversee PV activities, and available at all times. Inspections frequently reveal outdated PSMFs, delays in adverse event reporting, and insufficient training of staff or partners who may encounter safety information. Another common issue is a lack of evidence that the QPPV has the authority to act. To maintain compliance, MAHs should ensure all relevant staff – including sales, medical information, and distributors – are trained in safety reporting obligations. Contracts with partners must clearly define PV responsibilities, and audits should be conducted regularly with corrective actions documented. Authorities expect real-time safety monitoring, timely reporting, and demonstrable system oversight.

Scientific Service & Advertising Compliance

Core responsibilities:

• Maintain a scientific service responsible for providing scientific information on the product.
• Ensure all promotional and advertising materials comply with Directive 2001/83/EC (Articles 86–100) and national laws.
• Submit promotional materials to authorities for review where required by Member States.

• Training & Tracking Overview for Personnel Communicating with Healthcare Professionals

The requirement for a scientific service ensures that accurate and consistent information on the product is available. Authorities expect this service to review and approve all promotional and advertising materials before release. Promotional activity is closely regulated and must be consistent with the authorised SmPC and national advertising rules. Inspections often highlight cases where promotional claims go beyond the approved label, or where materials were not reviewed by the scientific service. Some authorities also report insufficient training of marketing staff. MAHs should therefore establish a documented process for promotional review, require scientific service sign-off, and monitor national requirements for pre-approval. Training for marketing and sales teams is essential to ensure compliance.

Documentation & Archiving

Core responsibilities:

• Retain and archive all documentation related to the product, including regulatory, clinical, quality, safety, and promotional data.
• Ensure that records are complete, accurate, and readily available for inspection.

Documentation underpins every MAH responsibility. Authorities require that records be accurate, complete, and retrievable at all times. Poor documentation practices are among the most common inspection findings, with issues such as missing records, poor version control, and difficulty retrieving documents on request. MAHs should use electronic document management systems with strict version control and access management. Retention policies must cover the full product lifecycle, and records should be reviewed periodically to ensure accuracy. Internal audits of documentation systems can help identify weaknesses before inspections. Authorities expect MAHs to demonstrate control of all product documentation, supporting transparency and traceability across the lifecycle.

Cross-Cutting Responsibilities & Sunset Clause

Core responsibilities:

• Notify authorities of prohibitions or restrictions imposed by other Member States.
• Comply with the “sunset clause,” under which an MA lapses if the product is not marketed for three consecutive years (unless an exemption is granted).
• Remain inspection-ready across all areas of responsibility.

Certain responsibilities cut across all functions. Authorities expect the MAH to notify them of any prohibitions or restrictions applied in other Member States. The sunset clause is a critical consideration: if a product is not placed on the market within three years of authorisation, or is absent for three consecutive years, the authorisation ceases to be valid unless an exemption is granted. Monitoring product market status and planning for exemptions where necessary is essential. Another recurring inspection finding is inadequate inspection readiness – regulators expect companies to maintain documentation and oversight continuously, not just in preparation for planned inspections. The guiding principle is accountability: even when tasks are delegated, the MAH remains responsible and must be able to demonstrate oversight.

Checklist

To simplify regulatory compliance, Insuvia experts have developed a dedicated checklist. This resource provides a clear and comprehensive overview of the responsibilities of Marketing Authorisation Holders (MAHs) under EU legislation. Designed as a practical compliance tool, it helps MAHs ensure that all key obligations are met efficiently and with confidence.

Fill the form below to receive your copy.

Conclusion

The MAH’s role extends far beyond obtaining an authorisation. It encompasses regulatory submissions, manufacturing oversight, distribution, pharmacovigilance, scientific service, advertising compliance, documentation, and broader lifecycle responsibilities. Authorities consistently emphasise that while tasks may be delegated, responsibility cannot.

Inspection findings often stem from weak oversight of third parties, incomplete documentation, and delays in communication with authorities. New MAHs can reduce these risks by establishing robust agreements, maintaining strong documentation systems, and embedding compliance across all functions. Meeting these responsibilities is not only a legal requirement but also central to safeguarding patients and maintaining regulatory trust.