Getting permission to sell a medicine in the EU/EEA is just the beginning. The person or company named on that approval is the Marketing Authorisation Holder (MAH), with regulatory duties that continue after approval.
An MAH may manufacture the medicine itself or work with a separate manufacturer. Either way, it remains responsible for the regulatory obligations linked to its marketing authorisation.
Below, we explain these responsibilities, including the MAH’s role in pharmacovigilance, and the requirements for companies operating in the EU/EEA.
What Is a Marketing Authorisation Holder (MAH)?
The name listed on a medicine’s marketing authorisation identifies its Marketing Authorisation Holder (MAH). The MAH may also manufacture the medicine, although these roles can be handled by different companies.
The MAH can use external service providers for certain activities. However, it is still legally responsible for meeting the regulatory requirements linked to its marketing authorisation.
Responsibilities of a Marketing Authorisation Holder
Getting approval for a medicine is only one part of the MAH’s role. Once the medicine is approved, the MAH still has regulatory responsibilities to fulfil in the EU/EEA. The main responsibilities are explained below.
1. Maintaining the Marketing Authorisation
The MAH must keep the regulatory dossier up to date and submit the necessary changes to its marketing authorisation. New findings that could affect the medicine’s benefit-risk balance must also be reported to the relevant competent authority, as required.
2. Pharmacovigilance and Safety Monitoring
The MAH is responsible for monitoring the safety of its medicines after approval. In the EU, it must operate a pharmacovigilance system, have a Qualified Person Responsible for Pharmacovigilance (QPPV) permanently and continuously available, and maintain a Pharmacovigilance System Master File (PSMF). The MAH must also manage the risk-management system required for its products.
3. Keeping Product Information Current
The MAH must make sure that authorised product information remains aligned with current scientific knowledge, including relevant regulatory assessment conclusions and recommendations.
4. Managing Quality and Manufacturing Changes
Where changes are needed to the authorised manufacturing or control methods, the MAH must take scientific and technical progress into account and obtain the required regulatory approval for those changes.
5. Meeting Post-Authorisation Obligations
Some marketing authorisations come with additional requirements. These may include safety or efficacy studies and measures to reduce known risks. The MAH must complete any such activities required by the relevant regulatory authority.
6. Notifying Authorities About Market Status
The MAH must notify the relevant competent authority when an authorised medicine is placed on the market. If marketing is temporarily or permanently discontinued, the authority must also be informed. Except in exceptional circumstances, this notification must be made at least two months before the interruption.
These responsibilities are covered by the EU regulatory framework, including Directive 2001/83/EC.
Why Is a Marketing Authorisation Holder Important?
A Marketing Authorisation Holder is more than a regulatory service provider. It is the person or company legally responsible for the medicine’s marketing authorisation. For medicines approved through the EU’s centralised procedure, the holder must be based in the EEA.
One approval through this procedure covers the EU Member States as well as Iceland, Liechtenstein and Norway. Companies can market the medicine in these countries, provided they also follow the relevant national rules and any conditions attached to the approval.
Having the correct MAH structure is especially important for companies that are not established in the EEA. Such companies may need an EEA-established legal entity to hold the centralised marketing authorisation and fulfil the associated regulatory responsibilities.
The MAH also provides regulatory continuity throughout the product lifecycle. This includes handling changes to the authorisation, updating product information, overseeing pharmacovigilance and completing any post-authorisation requirements.
Marketing Authorisation Holder vs Manufacturer
A company that holds a medicine’s marketing authorisation may also manufacture it. However, these two activities involve different responsibilities.
The MAH looks after the marketing authorisation. Its work includes keeping the approved product information current, handling regulatory changes and meeting pharmacovigilance requirements. It remains legally responsible for the obligations attached to the authorisation.
The manufacturer handles the production activities covered by its manufacturing authorisation. Manufacturers and importers operating in the EEA need the relevant authorisations and must follow EU Good Manufacturing Practice (GMP).
The two companies need to coordinate their work when manufacturing is handled separately from the MAH.
Current EU GMP guidance states that appropriate arrangements should be in place between the MAH and the manufacturer, and a direct written contract should be in place between the MAH and the manufacturing/import authorisation holder responsible for Qualified Person certification.
The main differences are outlined below.
| Marketing Authorisation Holder | Manufacturer |
| Holds the marketing authorisation. |
Holds the relevant manufacturing/import authorisation for the authorised activities.
|
| Responsible for the regulatory obligations linked to the authorised medicinal product. |
Responsible for manufacturing in accordance with the applicable authorisation and GMP.
|
| Maintains the marketing authorisation and approved product information. |
Manufactures, tests or imports the product according to the authorised arrangements.
|
| Oversees pharmacovigilance and other post-authorisation obligations. |
Operates under GMP and the applicable manufacturing quality system.
|
| May outsource manufacturing activities, but remains responsible for MAH obligations. |
May manufacture products for one or more MAHs.
|
Role of the Marketing Authorisation Holder in Pharmacovigilance
Once a medicine is approved, the MAH must continue checking its safety. Reports of suspected adverse reactions form part of this work. The MAH reviews these reports and other safety information through its pharmacovigilance system.
The MAH needs to have a Qualified Person Responsible for Pharmacovigilance (QPPV) at its disposal at all times. The QPPV oversees the system and needs sufficient authority and access to the information required for the role.
The Pharmacovigilance System Master File (PSMF) describes how the MAH’s pharmacovigilance system operates. The MAH needs to keep this file current. Regulatory authorities may request the file or inspect it.
Some pharmacovigilance activities can be handled by external service providers. Even then, the MAH remains responsible for compliance. Written agreements must clearly identify the activities assigned to each party.
Risk management is another part of the MAH’s work. The MAH must maintain the applicable risk-management system and carry out any additional safety activities required under its marketing authorisation.
For the official requirements, refer to European Medicines Agency’s Good Pharmacovigilance Practices (GVP).
Marketing Authorisation Holder and IDMP
For medicines approved in the EU/EEA, the MAH must send the required product details to EMA and keep them updated. EMA stores these details in its Article 57 database, known as the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
EMA is implementing the Identification of Medicinal Products (IDMP) standards in phases through its SPOR data-management framework, which covers Substance, Product, Organisation and Referential data. Within SPOR, the Organisations Management Service (OMS) includes organisation data for entities such as Marketing Authorisation Holders, sponsors, regulatory authorities and manufacturers.
For MAHs, accurate organisation and product data are therefore important for regulatory data management. Once a new marketing authorisation is granted, the MAH has 15 calendar days from notification to submit the required information to EMA. Changes to existing authorisations must also be reported within the applicable deadlines, generally within 30 calendar days.
MAHs can refer to EMA’s Article 57 data-submission guidance for the applicable reporting requirements. EMA introduced XEVMPDweb on 10 February 2026. Following a three-month transition, it became the required interface for external Article 57 users on 11 May 2026.
IDMP implementation should not be confused with a separate marketing-authorisation procedure. It is part of the EU’s move toward structured and standardised medicinal-product data across regulatory processes.
Who Can Act as a Marketing Authorisation Holder in the EU/EEA?
Both individuals and legally registered organisations can hold marketing authorisations. For medicines approved through the EU’s centralised procedure, they need to have an established presence in the EEA.
Companies applying through this procedure must provide EMA with proof of their legal establishment. This is part of the application requirements.
For a company based outside the EEA, the authorisation can be held by its EEA-established subsidiary or another eligible legal entity.
The MAH may rely on other companies for regulatory support. This does not change who is legally responsible for complying with the terms of the marketing authorisation.
More information is available in EMA’s pre-authorisation guidance.
Conclusion
The MAH’s work continues long after a medicine receives approval. It must keep the marketing authorisation up to date, monitor the medicine’s safety and meet the regulatory requirements that apply throughout its lifecycle.
Companies outside the EEA need an appropriately established EEA entity to hold a centralised marketing authorisation. Although an MAH can work with manufacturers and external service providers, it remains legally responsible for its authorisation.
Artixio offers support with MAH services, product registration, post-approval changes and regulatory compliance. Learn more about our Health Authority Liaison & Legal Representation Services.
