How National Marketing Authorisation Procedures Work in the EU

Introduction

The European medicines regulatory system is often described through the centralised procedure because it provides a single Union marketing authorisation. A large and important part of the system, however, remains based on national marketing authorisations granted by the competent authorities of individual Member States.

National authorisation is not a regulatory system outside EU pharmaceutical law. It operates within the common EU legal framework and is one of the foundations on which the mutual recognition and decentralised procedures are built.

This article explains what a national marketing authorisation is, how a purely national procedure works at a high level, and how national authorisations relate to the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). The detailed mechanics of MRP and DCP are addressed separately in Mutual Recognition Procedure (MRP): How It Works and Decentralised Procedure (DCP): How It Works. The division of work between the Reference Member State and Concerned Member States is addressed in Reference Member State (RMS) and Concerned Member States (CMS): Roles and Responsibilities.

The central question throughout is not whether a national procedure is “less European” than a centralised procedure. It is how the legal framework allocates assessment and authorisation responsibilities between the Member States and Union institutions.

1. What Is a National Marketing Authorisation?

A national marketing authorisation is an authorisation granted by the competent authority of a Member State under the applicable EU and national legal framework, permitting the medicinal product to be marketed within that Member State.

The national competent authority conducts the regulatory assessment and takes the authorisation decision within its legal remit.

The result differs from a centralised marketing authorisation in an important way:

• a centralised marketing authorisation is a Union authorisation granted by the European Commission following the centralised scientific procedure; whereas
• a national marketing authorisation is granted by the competent authority of an individual Member State.

The distinction concerns the legal route and authority granting the authorisation. It should not be interpreted as meaning that national authorities operate without common EU scientific and legal standards.

2. The Legal Framework for National Authorisation

The principal EU legal framework for nationally authorised human medicines is found in Directive 2001/83/EC, as amended, together with applicable national legislation and other relevant Union provisions.

The Directive establishes common requirements governing matters such as the application for a marketing authorisation, assessment of quality, safety and efficacy, product information, pharmacovigilance and other aspects of the medicinal-product lifecycle.

Member States transpose directives into national law and apply the resulting framework through their competent authorities.

For a live regulatory question, the current consolidated EU legislation and the applicable national legislation should both be checked. A general description of the EU framework cannot replace the legal requirements of the Member State concerned.

3. Who Grants a National Marketing Authorisation?

The relevant national competent authority (NCA) grants the national marketing authorisation.

The precise name and organisational structure of the authority differs between Member States. The regulatory principle is the same: the authorisation is a national legal act rather than a European Commission centralised authorisation.

The NCA may rely on internal assessors, external experts and national regulatory structures to evaluate the application.

The NCA is also part of the wider European regulatory network. National authorities participate in Union committees, working groups and procedures and contribute scientific and regulatory expertise to the EU system.

Thus, “national” does not mean isolated from Europe.

4. What Does the National Assessment Examine?

A national application is assessed against the applicable requirements for medicinal products.

The assessment can include:

• pharmaceutical quality and manufacturing;
• non-clinical evidence where relevant;
• clinical efficacy;
• clinical safety;
• benefit-risk balance;
• product information;
• pharmacovigilance arrangements; and
• risk-management requirements where applicable.

The precise assessment process depends on the application type and applicable legislation.

The fundamental regulatory question remains whether the evidence supports a marketing authorisation under the proposed conditions of use.

5. National Does Not Mean a Lower Scientific Standard

One of the most persistent misconceptions is that national authorisation represents a lower regulatory standard than centralised authorisation.

That is not an appropriate way to understand the EU system.

The Union pharmaceutical legislation establishes common substantive requirements for medicinal products. The regulatory route determines which authorities perform the assessment and which legal act creates the authorisation.

A national authority can therefore conduct a rigorous multidisciplinary assessment while exercising its national legal authority.

Differences between procedures should be described in terms of legal basis, scope, participating authorities, procedural architecture and territorial effect—not by assuming that one route is inherently more scientifically rigorous than another.

6. Purely National Procedures

A purely national procedure is the most straightforward form of national authorisation.

The applicant seeks authorisation in a single Member State, and the competent authority of that Member State conducts the assessment and grants the marketing authorisation if the applicable requirements are satisfied.

The procedure does not require the coordinated MRP or DCP framework because the applicant is not using the procedure to obtain national authorisations in multiple Member States through that mechanism.

A purely national authorisation can nevertheless become relevant to the wider EU system later. For example, the marketing authorisation may subsequently form the basis for a mutual recognition procedure when the holder seeks authorisation in additional Member States.

7. Why National Authorisations Remain Important

National marketing authorisations are not merely historical remnants from before the creation of EMA.

They remain an important route for medicines that fall outside the mandatory scope of the centralised procedure and for which the national routes are legally appropriate.

EMA itself describes national authorisation procedures as covering national procedures as well as MRP and DCP. Many generic medicines and medicines available without prescription are authorised through national-level routes, while many older medicines were authorised nationally before the current Union regulatory architecture developed.

The result is a large population of nationally authorised medicines operating within a common European pharmacovigilance and regulatory environment.

8. The Relationship Between National Authorisation and MRP

MRP begins with an existing national marketing authorisation.

Suppose a medicine has already been authorised in Member State A. The marketing authorisation holder later seeks authorisation for the same product in Member States B and C using the mutual recognition framework.

Member State A can act as the Reference Member State (RMS). The other participating Member States are Concerned Member States (CMSs).

The RMS assessment is then used as the basis for recognition in the participating Member States under the applicable legal procedure.

The resulting authorisations remain national authorisations. MRP does not convert the existing national marketing authorisation into a single Union marketing authorisation.

The detailed MRP sequence is covered in Article 23 of this series.

9. The Relationship Between National Authorisation and DCP

DCP is different because the participating Member States do not already have the relevant national marketing authorisation at the start of the procedure.

The applicant seeks authorisation in several Member States simultaneously through a coordinated procedure. One Member State acts as RMS and the others as CMSs.

The RMS coordinates the assessment and the participating authorities work within the common procedure.

When the procedure concludes successfully, national marketing authorisations are granted in the participating Member States.

Therefore:

MRP starts from an existing national authorisation; DCP starts from no relevant national authorisation in the participating Member States.

This distinction is foundational and should be established before trying to understand the detailed procedural timelines.

10. The Four Principal Authorisation Routes

The relationship can be represented simply:

This table is a conceptual map rather than a substitute for the legislation.

The product's legal eligibility and authorisation history must be established before selecting or interpreting a procedure.

11. National Authorisation and the European Regulatory Network

National competent authorities are connected through the European regulatory network.

They contribute to scientific committees, coordination groups, working parties and regulatory procedures. They also perform national responsibilities such as inspections and supervision of medicines on their territory.

This networked structure explains how national authorisations can coexist with Union-level procedures without requiring every medicine to be centrally authorised.

It also explains why a safety issue affecting a nationally authorised medicine can acquire Union-level significance and potentially enter an EU referral or coordination procedure.

The legal status of the marketing authorisation therefore does not prevent the product from becoming subject to Union regulatory action when the relevant legal conditions are met.

12. Product Information for Nationally Authorised Medicines

A national marketing authorisation includes authorised product information for the medicine.

For products authorised nationally, the applicable product information is maintained within the relevant national regulatory framework, subject to the harmonisation mechanisms established by EU law and the procedure used to authorise the medicine.

This becomes particularly important for medicines authorised through MRP or DCP, where common product-information texts and coordinated procedures support national authorisations.

The exact implementation of product-information changes depends on the procedure and applicable legal requirements.

The important distinction is that a national marketing authorisation does not automatically have the same legal documentation architecture as a centralised marketing authorisation.

13. National Authorisation and Pharmacovigilance

A nationally authorised medicine remains subject to the EU pharmacovigilance framework.

The marketing authorisation holder's pharmacovigilance responsibilities therefore do not depend on the product being centrally authorised.

National competent authorities participate in the EU pharmacovigilance network, and safety information concerning nationally authorised medicines can contribute to Union-level signal assessment and regulatory procedures.

This is particularly important for QPPVs. A portfolio containing nationally authorised medicines can involve interactions with several national authorities while also being subject to Union-level pharmacovigilance mechanisms.

The regulatory route and the pharmacovigilance system are therefore related but should not be treated as the same concept.

14. When a National Authorisation Becomes Part of a Union Procedure

A national marketing authorisation can become part of a broader Union procedure later in its lifecycle.

Examples include:

• entering an MRP to obtain authorisations in additional Member States;
• participation in a DCP-related regulatory history where applicable to subsequent procedures;
• a pharmacovigilance referral;
• an Article 30 or Article 31 procedure;
• an Article 29(4) disagreement procedure;
• Union coordination of safety or other regulatory issues.

The precise mechanism depends on the legal circumstances.

This is why a product's regulatory history should be read as a lifecycle rather than as a single authorisation event.

15. A Practical Regulatory Question

When reviewing a product's regulatory history, begin with four questions:

1. What type of marketing authorisation does the product have?
2. Which Member State or Union institution granted it?
3. In which territories does that authorisation have legal effect?
4. Which procedure created the authorisation?

Only after those questions are answered should the regulatory professional interpret later variations, referrals, safety procedures or national implementation.

A product may have a complicated regulatory history involving several procedures over time. The current authorisation status and the historical route by which it was established can both be relevant.

References

1. European Parliament and Council. Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended. Primary EU legal framework for national marketing authorisation, mutual recognition and decentralised procedures.
2. European Parliament and Council. Regulation (EC) No 726/2004, as amended. Primary legal framework for the centralised Union procedure and its relationship with the national system.
3. European Medicines Agency. Authorisation of medicines. Current overview distinguishing centralised and national authorisation procedures.
4. European Medicines Agency. Obtaining an EU marketing authorisation, step-by-step. Current procedural information concerning the centralised route and the European regulatory network.
5. Heads of Medicines Agencies / CMDh. Mutual recognition and decentralised procedures — human medicines. Current procedural information concerning national, MRP and DCP frameworks.

Regulatory Note

This article provides a high-level explanation of national marketing authorisation procedures within the EU medicines regulatory system. It is not legal advice and does not replace the current consolidated EU legislation, applicable national legislation, CMDh guidance, national competent-authority requirements or procedure-specific regulatory documents.

The term “national marketing authorisation” covers several regulatory situations. A purely national procedure, an MRP authorisation and a DCP authorisation are all national authorisations, but they are created through different procedural architectures. The detailed requirements should therefore be determined from the procedure that applies to the individual product.

The article deliberately does not reproduce the detailed MRP, DCP, RMS/CMS or disagreement procedures. Those topics are covered in the dedicated articles in this series. Cross-references should be understood as deliberate scope boundaries rather than omissions.

EU medicines legislation and national requirements change over time. For a live regulatory assessment, the current applicable legislation and procedure-specific regulatory documents take precedence over this educational explanation.

16. National Authorisation Is a Lifecycle State

A national marketing authorisation should not be treated as a static regulatory label. Its significance depends on the product's current authorisation history, the Member States in which it is authorised and the procedures through which those authorisations were established or subsequently modified.

For example, a product may begin with a purely national authorisation in one Member State and later obtain authorisations in several other Member States through mutual recognition. Later still, a safety issue may be considered through a Union referral procedure. The product remains a nationally authorised medicine, but its regulatory history has become increasingly European in scope.

This distinction is useful when reviewing regulatory databases. The fact that a product appears in an EU-level procedure does not necessarily mean that its marketing authorisation is a centralised authorisation.

The regulatory professional should distinguish between authorisation status and regulatory procedure.

17. The Role of the Marketing Authorisation Holder

The marketing authorisation holder is responsible for maintaining the national marketing authorisation in accordance with the applicable legal and regulatory requirements.

Depending on the product and procedure, this can include maintaining:

• the authorised product information;
• manufacturing and quality arrangements;
• pharmacovigilance arrangements;
• risk-management obligations where applicable;
• regulatory submissions and variations; and
• communication with the competent authorities.

For a portfolio spanning multiple Member States, the regulatory burden can be greater because national implementation and administrative requirements may coexist with common EU procedures.

This is one reason why understanding the underlying authorisation architecture matters operationally. The same scientific change can have different procedural consequences depending on whether the product is centrally authorised, nationally authorised, or authorised through MRP or DCP.

18. National Authorities and Union Coordination

A national competent authority can act independently within its national legal mandate while also participating in Union coordination mechanisms.

This dual role is a defining characteristic of the European regulatory network.

National authorities may therefore:

• grant or maintain national marketing authorisations;
• assess national regulatory submissions;
• participate in MRP and DCP;
• contribute experts to EMA committees and working groups;
• conduct inspections and supervision;
• contribute pharmacovigilance data and assessments; and
• participate in Union-level regulatory procedures.

The European system is consequently neither wholly centralised nor wholly national. It is a network in which different legal procedures allocate responsibilities at different levels.

19. What Happens When Member States Disagree?

The national, MRP and DCP frameworks contain mechanisms for managing disagreements between Member States.

In an MRP or DCP, a CMS may identify concerns that prevent agreement on the assessment or on the benefit-risk balance. Such disagreements are not resolved simply by treating the RMS assessment as automatically binding in every circumstance.

Where the applicable legal conditions are met, the matter can proceed to a Union-level procedure under the relevant provisions of EU pharmaceutical legislation.

This is an important transition point in the regulatory architecture:

National / coordinated assessment
              ↓
       Member State concern
              ↓
     Formal disagreement
              ↓
    Applicable EU procedure
              ↓
      Union-level outcome

The exact route depends on the legal basis and nature of the disagreement. The dedicated article on Article 29(4) Referral Procedures in EU Medicines Regulation examines one important mechanism in detail.

20. National Authorisation and Pharmacovigilance Oversight

The national status of an authorisation does not remove the product from the EU pharmacovigilance system.

Marketing authorisation holders must maintain pharmacovigilance systems capable of identifying, evaluating and communicating safety information in accordance with the applicable legislation. National competent authorities remain important recipients and evaluators of safety information, while the EU network provides mechanisms for coordination and Union-level assessment.

For QPPV oversight, the practical question is therefore not simply “Is this product nationally authorised?” It is:

Which authorities and Union procedures can become relevant to this product's pharmacovigilance lifecycle?

A portfolio may contain centrally authorised and nationally authorised products simultaneously. The QPPV system must support both without confusing their different regulatory pathways.

21. Variations and Other Post-Authorisation Changes

A national marketing authorisation can require regulatory maintenance throughout the product lifecycle.

Changes to manufacturing, quality, clinical information, safety information, product information or other authorised conditions may require an appropriate post-authorisation regulatory procedure.

The applicable procedure depends on the nature of the change and the legal framework governing the authorisation.

For products authorised through MRP or DCP, coordination between Member States can be required. For purely national products, the relevant national competent authority remains the principal regulatory authority for the national authorisation.

This illustrates why the authorisation route established at the beginning of the lifecycle remains relevant long after the original marketing-authorisation application has been completed.

22. A QPPV's Practical View of National Authorisations

From a QPPV perspective, a national authorisation should be understood as part of a broader regulatory map.

A useful portfolio-level record should allow the organisation to determine, for each product:

This information should be maintained as controlled regulatory data rather than reconstructed manually whenever a safety issue arises.

23. Common Misunderstandings

“Nationally authorised means outside the EU system.”

Incorrect. National marketing authorisations operate within the EU pharmaceutical framework and are connected to the European regulatory network.

“MRP creates a European marketing authorisation.”

Incorrect. MRP leads to national marketing authorisations in the participating Member States.

“DCP creates one authorisation for all participating countries.”

Incorrect. DCP coordinates the assessment but results in national authorisations.

“RMS is the European licensing authority.”

Incorrect. The RMS is a Member State authority performing the coordinating role defined by the MRP/DCP framework.

“National products are outside Union pharmacovigilance.”

Incorrect. Nationally authorised medicines are part of the EU pharmacovigilance system.

“A safety referral means the product became centrally authorised.”

Incorrect. A Union regulatory procedure can affect a nationally authorised product without changing the underlying type of marketing authorisation.

24. How to Read a Regulatory History Correctly

When reconstructing the history of a nationally authorised medicine, use a chronological approach.

Start with the original authorisation:

Initial national authorisation
          ↓
Possible MRP / DCP expansion
          ↓
Post-authorisation maintenance
          ↓
Safety / pharmacovigilance developments
          ↓
Possible Union procedure
          ↓
Current regulatory status

Then identify the legal basis for each major event.

This prevents a common analytical error: treating every later EU-level event as if it changed the fundamental authorisation route.

A referral, for example, may change the authorised conditions or impose regulatory measures without converting a national marketing authorisation into a centralised marketing authorisation.

25. Relationship to the Next Articles

This article establishes the national-authorisation foundation for the next parts of the series.

Mutual Recognition Procedure (MRP): How It Works will examine how an existing national assessment is recognised in additional Member States.

Decentralised Procedure (DCP): How It Works will examine the coordinated procedure used when the product is not yet authorised in the participating Member States.

Reference Member State (RMS) and Concerned Member States (CMS): Roles and Responsibilities will focus on the authorities that operate within those procedures.

The distinction between these concepts should be preserved. National authorisation describes the legal nature of the resulting authorisation; MRP and DCP describe particular procedural routes through which national authorisations can be established or expanded.

Key Takeaways

• A national marketing authorisation is a Member State authorisation operating within the common EU pharmaceutical framework.
• National authorisation is not synonymous with a purely national procedure; MRP and DCP also result in national marketing authorisations.
• MRP begins with an existing national authorisation, whereas DCP is used for coordinated authorisation where the relevant participating Member States do not yet have the authorisation.
• RMS and CMS are procedural roles within MRP and DCP, not Union licensing authorities.
• Nationally authorised medicines remain within the EU pharmacovigilance system and can become subject to Union-level procedures.
• A Union referral does not automatically convert a national marketing authorisation into a centralised authorisation.
• Regulatory history should distinguish the authorisation type from subsequent regulatory procedures.
• For QPPV oversight, authorisation status, participating Member States, authorities and Union procedures should be maintained as controlled regulatory information.

References

1. Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended.
2. Regulation (EC) No 726/2004, as amended.
3. European Medicines Agency. Authorisation of medicines.
4. Heads of Medicines Agencies / CMDh. Mutual recognition and decentralised procedures — human medicines.
5. European Commission. EudraLex, Volume 2 — Pharmaceutical legislation on medicinal products for human use.

Regulatory Note

This article is an educational explanation of the EU medicines regulatory framework. It does not replace the current consolidated legislation, national legislation, CMDh guidance, national competent-authority guidance or procedure-specific regulatory documents. Requirements can change, and the applicable current legal framework should be checked for live regulatory decisions.