MAHs: Are Your GMP–GVP Interfaces Aligned?

And here’s a bigger question: Does your GMP Quality System’s self‑inspection programme genuinely extend to pharmacovigilance, artwork, and labelling communication pathways?

In an era where compliance gaps can appear in the “in‑between” spaces of responsibility, ensuring full alignment across MAH obligations is vital.

Firstly a reminder of the core Obligations of Marketing Authorisation Holders (MAHs)

1. Regulatory Compliance and Documentation

MAHs must comply with the content and conditions of their marketing authorisation throughout the product lifecycle. This includes filing variation applications and obtaining approval before implementing any changes to the product, manufacturing process, or product information. They must notify competent authorities when launching a product, as well as any suspension or withdrawal from the market. Renewal applications must be submitted at least nine months before the authorisation expires.

1. Pharmacovigilance Responsibilities

Marketing authorisation holders are legally required to submit Periodic Safety Update Reports (PSURs) according to data lock points published in the EU Reference Dates (EURD) list, which is legally binding.

MAHs must maintain a pharmacovigilance system that includes monitoring products post-market to detect adverse events, reporting serious adverse events to health authorities, implementing risk management plans when required, and conducting post-authorisation safety studies as needed. The presentation of PSURs does not exempt MAHs from reporting important new safety and efficacy information as it emerges.

1. Manufacturing and Quality Standards

Although manufacturing is often outsourced, the MAH retains ultimate responsibility for ensuring all operations comply with Good Manufacturing Practice (GMP) and are consistent with the marketing authorisation. Written technical agreements must define roles, responsibilities, and reporting timelines with contract manufacturers, particularly for changes and deviations.

MAHs must conduct or oversee audits and qualification activities of manufacturing sites, conduct periodic Product Quality Reviews to assess product quality, and ensure each batch is certified by a Qualified Person (QP) against both GMP standards and the authorised dossier before release.

1. Supply Chain and Distribution

MAHs are responsible for ensuring continuous supply of their products to meet patient needs. They must monitor supply continuity and promptly report any shortages or supply disruptions to competent authorities. This includes handling quality defects, complaints, and product recalls when necessary.

1. Communication and Information Management

MAHs must maintain effective communication with manufacturing sites regarding marketing authorisation dossier information, variations, regulatory commitments, and changes. They should establish shared repositories for critical information including registration details, current labelling and artwork, approved variations, deviation records, and audit reports.

1. Compliance with Good Practice Standards

Compliance with these standards ensures the reliability and integrity of the data that support the authorisation of medicines and their quality, safety and effectiveness once on the market :

• Good Manufacturing Practice (GMP) for production
• Good Distribution Practice (GDP) for supply chain
• Good Pharmacovigilance Practices (GVP) for safety monitoring

1. Documentation and Record Keeping

MAHs must maintain comprehensive documentation systems with version control, keep regulatory calendars covering deadlines for renewals, fees, periodic reports, and notifications, and retain reference and retention samples as specified in GMP guidelines.

1. Advertising and Promotion Compliance

MAHs are responsible for ensuring all promotional materials and advertising comply with regulatory requirements and accurately reflect the approved product information.

Nota bene:  Non-Delegable Responsibility

While MAHs can outsource or delegate the above tasks to third parties (such as contract manufacturers, distributors, or service providers), the ultimate responsibility cannot be transferred. Regulatory authorities consistently emphasise that the MAH remains legally accountable for all aspects of the product’s lifecycle, regardless of which organization performs the actual activities. Therefore,  the MAH is responsible for ensuring that they and any parties working for them comply with all relevant standards set out in European Union (EU) legislation and guidelines

A sample of considerations:

Does your quality system sufficiently cover the MAH responsibilities?

Health authorities have noted that in several companies the MAH quality system was either under‑resourced or almost entirely aligned to GDP wholesaling, leaving regulatory affairs and marketing governance out in the cold

Do you have adequate oversight and communication with third parties?

Common inspection findings relate to weak oversight of third parties, incomplete documentation, delays in communication with authorities, and unapproved changes introduced without proper notification.

Is your training system fit for purpose?

Regulators have criticised marketing training that is generic, undocumented or skewed towards product features rather than risk and regulatory obligations. One HPRA report notes that a one‑day product refresher for sales and marketing teams covering seven medicines assessed effectiveness via an “open‑to‑floor quiz,” with little focus on adverse events and warnings, and that one representative did not feel “qualified to discuss the gastro‑intestinal risk issues” of the product they promoted.

Consequences of Non-Compliance

Failure to meet these obligations can result in regulatory actions including variations, suspensions, or revocations of marketing authorisations by the European Commission, based on recommendations from EMA.

The MAH’s role is comprehensive and ongoing, extending far beyond the initial approval of a marketing authorisation. Success requires robust systems, clear procedures, effective oversight of all parties involved in the product lifecycle, and proactive communication with regulatory authorities.

Now is the time for MAHs to proactively assess their internal structures and oversight mechanisms, ensuring that no part of the product lifecycle sits unmanaged in the “in‑between” spaces where compliance gaps typically emerge.

How MIAS Pharma Can Support MAHs

Based on common industry challenges and the needs reflected in the article, MIAS Pharma offers a suite of tailored services to help MAHs strengthen compliance, governance, and operational excellence:

1. MAH Gap Assessment

Using deep QP, GMP, GDP, and regulatory expertise, MIAS can perform a structured gap assessment across:

• MAH Quality Systems
• GMP/GDP oversight
• Labelling, artwork & communication pathways
• Third‑party oversight and technical agreements

1.  Fractional Expertise & Oversight (QP / Technical / MAH Support)

Whether you need short‑term, fractional, or project‑specific resources, MIAS can provide:

• Fractional QP support
• Fractional Quality Expert or Technical SME
• Support for batch certification alignment with MA dossier
• PV/QPPV interface oversight (in collaboration with your PV provider)
• Support with Product Quality Reviews, audit readiness & third‑party qualification

This is ideal for MAHs needing flexible capacity without long‑term headcount expansion.

1. Tailored MAH Services & End‑to‑End Support

MIAS Pharma can partner with MAHs to deliver customised support across:

• Building or enhancing MAH Quality Systems
• Documentation and regulatory calendar management
• Governance of variations, renewals & lifecycle activities
• Labelling/artwork change management processes
• Development of training programmes tailored to regulatory responsibilities
• Supplier and CMO oversight programmes
• Preparation for inspections and authority interactions

MIAS already supports clients with MA readiness, QP declarations, and regulatory alignment throughout the MA lifecycle.