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Centralised, National, Mutual Recognition and Decentralised Procedures Explained

A practical and regulatory comparison of centralised, national, mutual-recognition and decentralised marketing-authorisation procedures in the European Union.

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Centralised, National, Mutual Recognition and Decentralised Procedures Explained

Introduction

A medicinal product can obtain a marketing authorisation in the European Union through different regulatory routes.

The principal routes for human medicines are:

These routes should not be understood as different levels of regulatory quality.

They are different procedural mechanisms for obtaining and maintaining a marketing authorisation within the EU regulatory framework.

The scientific standards are common.

The regulatory architecture is not.

The route determines, among other things:

EMA explicitly states that the data requirements and standards governing the authorisation of medicines are the same in the EU irrespective of the authorisation route. 1

The central question is therefore not:

"Which route has the highest scientific standard?"

It is:

"Which legal and procedural route applies to this medicinal product and regulatory objective?"

1. The Four Routes at a Glance

A useful first comparison is:

Route Basic situation Main regulatory mechanism
Centralised EU-wide authorisation through the Union procedure Single EU marketing authorisation
National Authorisation sought in one Member State National competent authority
Mutual recognition Product already authorised in one Member State Other Member States recognise the existing authorisation
Decentralised Product not yet authorised in the EU and authorisation sought in several Member States Coordinated simultaneous national authorisation

This table is deliberately simplified.

The detailed legal requirements depend on:

2. The First Question: Is the Centralised Procedure Required?

Before considering MRP or DCP, the applicant must establish whether the medicinal product falls within the scope of the centralised procedure.

For certain categories of medicines, the centralised procedure is compulsory.

EMA identifies mandatory categories including certain medicines containing new active substances for specified serious diseases, biotechnology-derived medicines, advanced therapy medicinal products and orphan medicines. 2

The legislation should be consulted to determine the precise scope.

The practical sequence is therefore:

Medicinal product
      |
      v
Is centralised procedure
   compulsory?
      |
  +---+---+
  |       |
 Yes      No
  |       |
  v       v

Centralised Consider procedure other routes

If the centralised procedure is compulsory, the applicant cannot simply choose a national route instead.

3. When the Centralised Procedure Is Optional

For certain medicines outside the compulsory scope, the centralised procedure may be available as an option.

EMA describes optional access for certain medicines where, for example, the product contains a new active substance for an indication outside the mandatory categories, represents significant therapeutic, scientific or technical innovation, or where EU-level authorisation is considered to be in the interest of public health. 3

The exact eligibility criteria are defined by EU legislation.

The important principle is:

Centralised versus non-centralised is not simply a commercial choice.

The applicant must first establish the legal eligibility of the product.

4. The Centralised Procedure

The centralised procedure is an EU-level authorisation route.

The applicant submits a single application to EMA.

For human medicines, the Committee for Medicinal Products for Human Use (CHMP) performs the scientific assessment within its remit.

The CHMP adopts a scientific opinion.

The European Commission then takes the legally binding decision.

Once granted, the centralised marketing authorisation is valid throughout the EU and, under the applicable arrangements, in Iceland, Liechtenstein and Norway. 4

The simplified sequence is:

Applicant
   |
   v
  EMA
   |
   v
  CHMP
   |
   v
Scientific opinion
   |
   v
European Commission
   |
   v
Centralised marketing
authorisation
   |
   v
EU/EEA coverage

The centralised route therefore produces a single Union marketing authorisation rather than separate national authorisations.

5. What Is Distinctive About the Centralised Procedure?

The defining characteristic is not merely that EMA is involved.

It is that the procedure results in a single EU marketing authorisation.

This creates a different regulatory architecture from the national, MRP and DCP routes.

For example, the centralised route provides:

Post-authorisation procedures for centrally authorised products consequently follow the centralised regulatory framework.

6. The National Procedure

The national procedure is the simplest of the four concepts.

A company seeks authorisation in one Member State.

The relevant national competent authority evaluates the application and, where the legal requirements are satisfied, grants the national marketing authorisation.

The authorisation is therefore specific to that Member State.

A medicine may have a national authorisation in one Member State without having a marketing authorisation in every other Member State.

This is particularly important when interpreting the phrase:

"Authorised in the EU."

A medicine can be authorised in an EU Member State without being centrally authorised across the Union.

7. Why National Procedures Still Matter

National procedures are not merely a historical leftover from before EMA existed.

They remain an important component of the EU system.

EMA notes that the majority of medicines available in the EU were authorised at national level, including products authorised before EMA was created and products outside the scope of the centralised procedure. 5

National competent authorities therefore remain central to the European regulatory network.

They perform functions including:

8. From One Member State to Several

Suppose a company has obtained a national marketing authorisation in one Member State.

It now wants the same medicine authorised in several additional Member States.

If the product is outside the centralised procedure, two major mechanisms may become relevant:

The key question is:

Does a marketing authorisation already exist in an EU Member State?

If yes, MRP may be appropriate.

If no, DCP may be appropriate.

That is the basic distinction.

9. The Mutual Recognition Procedure

The mutual-recognition procedure is used where a medicinal product already has a marketing authorisation in one Member State.

That Member State is the:

Reference Member State (RMS).

The applicant can seek recognition of the existing authorisation in one or more additional Member States.

Those additional Member States are:

Concerned Member States (CMSs).

The basic concept is:

Existing national MA
        |
        v
   Reference Member
      State (RMS)
        |
        v
 Scientific assessment
    already exists
        |
        v
  Mutual recognition
        |
   +----+----+
   |         |
   v         v
 CMS 1     CMS 2
   |         |
   +----+----+
        |
        v
 National authorisations

The CMSs rely on the assessment performed through the established procedure, subject to the applicable legal framework.

10. Why Is It Called Mutual Recognition?

The term describes the principle that Member States recognise an existing authorisation rather than requiring a completely independent new assessment of the same application.

The system is based on mutual reliance.

The reference Member State has already performed the principal assessment.

The concerned Member States participate in the procedure and recognise the resulting assessment subject to the applicable rules.

This mechanism reduces unnecessary duplication.

It also promotes consistency across Member States.

11. The Decentralised Procedure

The decentralised procedure operates differently.

It applies where the medicinal product has not yet been authorised in the EU and the applicant seeks authorisation in more than one Member State simultaneously, provided the product is eligible for the decentralised route.

EMA defines the DCP as a procedure through which a medicine that has not yet been authorised in the EU can be authorised simultaneously in more than one Member State. 6

The applicant identifies:

The RMS conducts the principal assessment.

The CMSs participate in the coordinated assessment.

The outcome is then implemented through national marketing-authorisation decisions in the participating Member States.

12. MRP Versus DCP: The Essential Difference

The simplest distinction is:

MRP starts with an existing national marketing authorisation.

DCP starts without an existing EU national marketing authorisation.

Compare:

Feature MRP DCP
Existing EU national MA Yes No
RMS Yes Yes
CMSs Yes Yes
Timing Recognition of existing MA Simultaneous assessment
Principal assessment Existing RMS assessment RMS assessment during procedure
Outcome National MAs recognising the existing assessment National MAs following coordinated assessment

This is the distinction that should be remembered first.

13. The RMS

The Reference Member State performs the principal coordinating role in MRP and DCP.

Its responsibilities can include:

The RMS does not become the regulatory authority for all CMSs.

Each Member State retains its national regulatory authority.

The RMS is therefore a procedural and scientific coordinating role, not a replacement for the national authorities of the CMSs.

14. The CMS

The Concerned Member States are the additional Member States participating in the MRP or DCP.

Their role is not merely administrative.

They review the assessment and participate in the regulatory procedure.

The system is designed to produce a common scientific and regulatory outcome across the participating Member States while retaining the national authorisation structure.

This is why the procedure is genuinely European even though the final authorisations are national.

15. What Is the Assessment Report?

The assessment report is an important document in MRP and DCP.

It records the scientific assessment of the medicinal product.

It can address:

The report provides the scientific foundation on which the participating Member States base the procedure.

The RMS plays a central role in preparing and maintaining the assessment report.

16. The Product Information in MRP and DCP

The regulatory process also seeks agreement on the product information.

This can include:

The objective is to establish harmonised product information for the medicine across the participating Member States, subject to the applicable linguistic and national requirements.

The scientific assessment and product information therefore develop together.

17. The Outcome of an MRP

When the participating Member States reach agreement, the procedure is closed.

The CMSs then recognise the RMS assessment according to the applicable legal framework.

The national authorities issue or maintain the national marketing authorisations.

The result is therefore:

multiple national marketing authorisations based on a coordinated European procedure.

This differs fundamentally from the centralised procedure.

18. The Outcome of a DCP

The DCP also leads to national marketing authorisations.

The difference is that the coordinated assessment takes place before the medicine has been authorised in the participating Member States.

The sequence is:

Application
    |
    v
RMS + CMS assessment
    |
    v
Agreement
    |
    v
National authorisation
in participating MSs

Thus:

Centralised procedure → one Union marketing authorisation

DCP → coordinated national marketing authorisations

This is one of the most important distinctions in EU regulatory affairs.

19. The Role of CMDh

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) coordinates questions relating to human medicines authorised in two or more Member States through the MRP or DCP.

EMA describes CMDh as the group responsible for examining and coordinating questions concerning marketing authorisations and variations under the mutual-recognition and decentralised procedures. 7

CMDh therefore becomes particularly important when:

CMDh should not be confused with CHMP.

20. CMDh Versus CHMP

A useful distinction is:

Body Principal relevance
CHMP Scientific assessment of centrally authorised human medicines and specified EU procedures
PRAC Pharmacovigilance risk assessment
CMDh Coordination of MRP/DCP nationally authorised human medicines

This does not mean that the committees operate in isolation.

EU procedures can connect them.

For example, a safety referral involving nationally authorised medicines may involve PRAC followed by CMDh, depending on the legal procedure. EMA explicitly describes this relationship. 8

21. What Happens If Member States Disagree?

This is where the MRP/DCP framework becomes particularly important.

The system is designed around mutual recognition and coordinated assessment.

But agreement is not guaranteed.

A Member State may consider that there is a:

potential serious risk to public health

and disagree with the assessment or proposed regulatory position.

This is not simply a commercial disagreement.

The legislation provides a formal mechanism for dealing with such disagreement.

22. Article 29: Disagreement During MRP or DCP

Article 29 of Directive 2001/83/EC addresses disagreements during the mutual-recognition or decentralised procedure.

Where a Member State cannot approve the assessment report, SmPC, labelling or package leaflet on the grounds of a potential serious risk to public health, it must provide a detailed explanation of its position.

The points of disagreement are referred to the coordination group.

The EUR-Lex text of Directive 2001/83/EC sets out this mechanism and the requirement for a detailed explanation of the grounds for disagreement. 9

This is an important point:

An MRP or DCP does not eliminate national scientific scrutiny.

It creates a structured system for coordinating that scrutiny.

23. The 60-Day CMDh Stage

When a disagreement arises on the relevant grounds, CMDh considers the matter.

EMA states that CMDh seeks to reach an agreement within 60 days. If agreement cannot be reached, the matter can progress to CHMP for the applicable further procedure. 10

Conceptually:

MRP / DCP
    |
    v
Member State disagreement
    |
    v
Potential serious risk
to public health
    |
    v
   CMDh
    |
    |-- Agreement
    |       |
    |       v
    |   Procedure continues
    |
    +-- No agreement
            |
            v
          CHMP
            |
            v
      EU-level procedure

The detailed legal pathway depends on the circumstances.

24. Why This Is Not Simply "Arbitration"

Older regulatory terminology sometimes describes these procedures as involving "arbitration".

The modern EU framework should be described using the terminology of the current legislation and regulatory guidance.

The key concept is that a disagreement can move from the MRP/DCP coordination process into an EU-level procedure when the applicable legal criteria are met.

This provides a mechanism for resolving significant scientific disagreement.

25. Article 29(4) and the Serious-Risk Concept

The phrase:

"potential serious risk to public health"

has a specific regulatory significance.

It should not be used casually to describe any safety concern.

A potential serious risk to public health is a legal and procedural threshold within the applicable framework.

Therefore, a company should not infer that an Article 29(4) procedure is appropriate simply because a safety issue is clinically important.

The legal criteria and procedural context must be assessed.

This distinction becomes particularly important in referral work.

26. MRP/DCP Disagreement Versus a Later Referral

An MRP/DCP disagreement and a post-authorisation EU referral are related concepts but are not the same procedure.

For example:

During authorisation

Member States disagree during an MRP or DCP.

The applicable Article 29 mechanism may become relevant.

After authorisation

A safety issue later affects an already authorised medicine.

A different EU referral mechanism may become relevant depending on the circumstances.

This distinction prevents a common regulatory error:

treating every disagreement concerning a nationally authorised medicine as an Article 31 referral.

The legal stage and question matter.

27. Article 30 Is Also Different

Article 30 referrals address another situation.

EMA explains that an Article 30 referral may be initiated where divergent decisions have been adopted by Member States concerning the authorisation, suspension or revocation of a medicinal product, or to promote harmonisation of national authorisations. 11

The important distinction is:

These procedures should not be collapsed into one generic category of "EU referral".

28. The Centralised Route Versus MRP/DCP

The difference can be visualised as:

CENTRALised
------------
One EU application
        |
        v
      EMA
        |
        v
      CHMP
        |
        v
European Commission
        |
        v
One Union MA


MRP / DCP
----------
RMS + CMSs
        |
        v
Coordinated assessment
        |
        v
National authorities
        |
        v
Multiple national MAs

The scientific standards are common.

The legal architecture is different.

29. National Authorisation Versus MRP

Consider two situations.

Situation A

A company wants to market a medicine only in France.

A national procedure may be sufficient if the product is eligible.

Situation B

The same company wants the medicine authorised in France, Germany and Spain and already holds an eligible French authorisation.

MRP may allow Germany and Spain to recognise the existing assessment.

The commercial objective is similar.

The regulatory pathway is different because the starting regulatory position is different.

30. National Authorisation Versus DCP

Now consider a medicine that has not yet been authorised in any EU Member State.

The company wants authorisation in:

If the product is eligible for DCP, the company can conduct a coordinated assessment through an RMS and CMSs rather than obtaining one national authorisation first and then pursuing MRP.

Thus:

Existing authorisation → MRP

No existing EU authorisation → DCP

This is the most useful practical distinction.

31. Why the RMS Is So Important

The RMS is the centre of the scientific and procedural coordination for MRP/DCP.

The RMS prepares or maintains the assessment documentation and coordinates interactions with the CMSs.

However, the RMS is not "the European regulator".

It is a Member State authority performing a defined coordinating function within a European procedure.

This distinction is important when interpreting regulatory correspondence.

32. Why CMSs Matter

CMSs provide national regulatory participation.

They can:

The procedure therefore combines:

central coordination

with:

national regulatory responsibility.

This is one of the defining characteristics of the European network.

33. National Authorisations After MRP/DCP

An MRP or DCP does not create one centrally authorised product.

It results in national marketing authorisations in the participating Member States.

This has practical consequences.

For example, the MAH may need to manage:

At the same time, the scientific assessment and core product information are coordinated through the European procedure.

34. Product Information and Translation

A coordinated procedure must ultimately produce product information suitable for each participating Member State.

This involves linguistic and national implementation requirements.

The scientific content should remain aligned.

The national presentations must comply with the applicable requirements.

This is one reason why regulatory implementation continues after the scientific agreement itself.

35. The Regulatory Route Can Affect Post-Authorisation Work

The authorisation route matters after approval.

For a centrally authorised product:

For nationally authorised products:

Therefore, the authorisation route should be captured in the regulatory master data for a product.

36. Why Pharmacovigilance Professionals Need to Know the Route

A safety issue does not exist in a regulatory vacuum.

Suppose an MAH identifies an important safety signal.

The first regulatory questions should include:

The answers can materially influence the regulatory pathway.

37. A Worked Pharmacovigilance Example

Suppose an active substance is marketed through DCP in eight Member States.

A new serious adverse reaction is identified.

The MAH conducts a signal assessment.

The concern is potentially relevant to all eight countries.

The regulatory strategy cannot simply treat the issue as an isolated national matter without considering the wider authorisation structure.

The organisation should map:

Active substance
      |
      v
Products and strengths
      |
      v
Member States
      |
      v
Authorisation route
      |
      v
Existing safety information
      |
      v
Signal assessment
      |
      v
Regulatory significance
      |
      v
Appropriate EU/national action

The precise action depends on the evidence and applicable law.

The example illustrates why regulatory status is essential to pharmacovigilance governance.

38. Another Example: A New Application

Consider a medicine that has never been authorised in the EU.

The applicant wants approval in five Member States.

The medicine is not within the mandatory scope of the centralised procedure.

The company may consider DCP.

One Member State acts as RMS.

The other four are CMSs.

The RMS conducts the principal assessment.

The CMSs participate.

If agreement is reached, national marketing authorisations can be granted in the participating Member States.

The result is coordinated national authorisation rather than one central EU authorisation.

39. Another Example: An Existing Authorisation

Now change one fact.

The same medicine is already authorised in Germany.

The company now wants authorisation in four additional Member States.

The regulatory starting point has changed.

There is already an EU national marketing authorisation.

MRP may therefore be the appropriate route.

Germany can act as RMS.

The additional Member States can participate as CMSs.

The procedure is based on recognition of the existing authorisation rather than a new DCP assessment from the beginning.

40. Another Example: A Centrally Authorised Product

Now consider a medicine within the mandatory centralised scope.

The applicant cannot simply choose DCP because it prefers a decentralised approach.

The centralised procedure applies.

The application is assessed through EMA and CHMP.

The European Commission takes the central marketing-authorisation decision.

The product therefore enters a different regulatory lifecycle from the outset.

41. The Same Active Substance Can Exist Under Different Routes

A particularly important concept is that the same active substance can appear in products with different regulatory histories.

For example:

Therefore, the phrase:

"The active substance is authorised in Europe"

does not tell you enough.

A regulatory assessment should establish:

42. Regulatory Status Is Not the Same as Active Substance Status

This distinction is particularly important in pharmacovigilance.

A signal may concern an active substance.

But regulatory action must ultimately be mapped to:

This is why regulatory intelligence systems need structured product-level information.

43. Common Misconception: MRP Is a Lower-Level Centralised Procedure

Incorrect.

MRP is not a smaller version of the centralised procedure.

The legal architecture is fundamentally different.

MRP results in national marketing authorisations.

The centralised procedure results in one Union marketing authorisation.

The scientific standards are common.

The legal authorisation structure differs.

44. Common Misconception: DCP Means Each Country Performs a Separate Assessment

Not exactly.

DCP is designed to coordinate the assessment through an RMS and CMSs.

The RMS performs the principal assessment and coordinates the procedure.

The CMSs participate in the scientific and regulatory review.

The result is coordinated national authorisation.

It is therefore neither a purely national procedure nor a centralised procedure.

45. Common Misconception: CMSs Simply Rubber-Stamp the RMS

Incorrect.

CMSs participate in the assessment and can raise concerns.

The regulatory framework is based on coordinated scientific review and agreement.

Where a CMS considers that a potential serious risk to public health prevents agreement, the legislation provides mechanisms for escalation. 12

46. Common Misconception: National Medicines Are Outside EMA's Regulatory Environment

Incorrect.

Nationally authorised medicines remain within the EU medicines regulatory framework.

EMA and EU committees can become involved in specified procedures, particularly where:

The regulatory route is national or coordinated-national.

The underlying legal environment remains European.

47. Common Misconception: Centralised Means No National Regulatory Role

Also incorrect.

Even with a centralised marketing authorisation, national competent authorities retain important responsibilities.

These can include:

The centralised procedure does not abolish national regulators.

It changes the authorisation mechanism.

48. How to Identify the Route From a Regulatory Document

When opening a regulatory document, look for clues.

Centralised

Look for:

MRP/DCP

Look for:

National

Look for:

This is not a substitute for checking the formal procedure.

It is a useful first-pass orientation tool.

49. A Decision Tree

A practical decision tree is:

Is the product within the
mandatory centralised scope?
          |
      +---+---+
      |       |
     Yes      No
      |       |
      v       v
Centralised   Is it already
 procedure    authorised in
              an EU MS?
                  |
              +---+---+
              |       |
             Yes      No
              |       |
              v       v
             MRP      DCP
              |       |
              +---+---+
                  |
                  v
          Multiple national
             authorisations

A national procedure remains an option where the company seeks authorisation in a single Member State and the product is eligible for that route.

50. A More Complete Decision Framework

The practical questions are:

Question 1

Is the centralised procedure compulsory?

If yes, centralised.

Question 2

If not compulsory, is centralised authorisation otherwise available and strategically appropriate?

If yes, centralised may be considered.

Question 3

Is the medicine intended for one Member State only?

If yes, a national procedure may be relevant.

Question 4

Is there already a national marketing authorisation in an EU Member State?

If yes, MRP may be relevant for additional Member States.

Question 5

Has the medicine not yet been authorised in the EU and is authorisation sought in several Member States?

If yes, DCP may be relevant.

Question 6

Is there disagreement among Member States?

If yes, identify the precise procedural stage and legal basis before deciding what escalation mechanism applies.

51. Why the Starting Point Matters

The most efficient way to determine the procedure is to establish the regulatory starting point.

There are three particularly useful questions:

Is centralised authorisation required?

Does an EU national authorisation already exist?

How many Member States are involved?

These questions often narrow the possible pathways rapidly.

52. The Relationship Between Procedure and Regulatory Geography

The four routes can also be viewed geographically.

Centralised

One EU-level authorisation.

National

One Member State.

MRP

Several Member States, starting from an existing national authorisation.

DCP

Several Member States, starting without an existing EU national authorisation.

This geographic model is useful, but it should not obscure the legal distinctions.

53. What the Routes Have in Common

Despite their differences, the procedures share important characteristics.

They operate within the EU pharmaceutical legal framework.

They require appropriate evidence concerning:

They involve regulatory assessment.

They result in defined conditions of use.

They are subject to continuing post-authorisation obligations.

They can be affected by new scientific evidence.

They can ultimately lead to changes in the authorised conditions of use.

The common regulatory objective is protection of public health through appropriate benefit-risk assessment.

54. What the Routes Do Not Have in Common

The routes differ in:

These differences matter operationally.

A regulatory professional should therefore never infer the procedure solely from the fact that a product is "EU authorised."

55. Implications for the Marketing Authorisation Holder

The MAH should maintain a clear understanding of the regulatory route for each product.

The regulatory system should be able to identify:

This information is important for both Regulatory Affairs and Pharmacovigilance.

56. Implications for Pharmacovigilance Governance

For pharmacovigilance, the route matters because regulatory action may need to be coordinated across different authorities.

For example, a safety issue affecting an MRP/DCP product may require:

The appropriate pathway depends on the legal circumstances.

The important principle is:

The regulatory footprint of the product should be known before deciding how a safety issue should be escalated.

57. Implications for QPPV Oversight

A QPPV should be able to understand the regulatory context of the products under pharmacovigilance oversight.

At minimum, the QPPV should be able to determine:

This does not mean the QPPV personally manages every regulatory submission.

It means that pharmacovigilance governance must be connected to the regulatory status of the product.

58. Implications for Inspection

During inspection, an organisation may be asked to demonstrate that regulatory information is correctly linked to pharmacovigilance activities.

For an MRP/DCP product, an inspector might reasonably expect the organisation to understand:

The precise inspection scope depends on the inspection.

The broader principle is traceability.

59. The Importance of Current Regulatory Information

The procedure used to obtain an authorisation is not necessarily the whole story.

A product can later undergo:

Therefore, the organisation should distinguish:

historical authorisation route

from:

current regulatory status.

Both can be relevant.

60. A Worked Comparison

Consider three products containing the same active substance.

Product A

Centrally authorised.

Regulatory architecture:

EMA
  |
CHMP
  |
European Commission
  |
One EU marketing authorisation

Product B

Authorised through DCP in six Member States.

Regulatory architecture:

RMS
  |
CMSs
  |
Coordinated assessment
  |
Six national MAs

Product C

Initially authorised nationally in Germany and subsequently recognised through MRP in four additional Member States.

Regulatory architecture:

Existing German MA
      |
     RMS
      |
  MRP process
      |
   CMSs
      |
Multiple national MAs

All three products may contain the same active substance.

Their regulatory structures are nevertheless different.

61. Why This Matters When a Safety Issue Emerges

Suppose the same serious adverse reaction is identified for all three products.

The scientific question may initially be similar:

Is there a causal association?

The regulatory question may then differ because the authorisation structures differ.

For Product A:

For Product B:

For Product C:

This is one of the clearest reasons that regulatory route is not merely administrative metadata.

62. The Most Important Distinction

The entire article can be reduced to four concepts:

Centralised = one Union authorisation.

National = one Member State authorisation.

MRP = recognise an existing national authorisation in additional Member States.

DCP = seek coordinated authorisation in several Member States before an EU national authorisation exists.

These definitions are simple.

The regulatory consequences are not.

63. What Happens After the Procedure?

The authorisation route becomes part of the product's continuing regulatory identity.

After authorisation, the MAH may need to manage:

For centrally authorised products, these processes follow the centralised framework.

For nationally authorised products, the relevant national and EU coordination mechanisms apply.

64. Why the Next Regulatory Questions Become Easier

Once the authorisation route is understood, later EU regulatory procedures become easier to interpret.

For example:

Regulatory concepts become much easier when their procedural context is established first.

65. Common Terminology

Abbreviation Meaning
MA Marketing authorisation
MAH Marketing authorisation holder
RMS Reference Member State
CMS Concerned Member State
MRP Mutual-recognition procedure
DCP Decentralised procedure
NCA National competent authority
EMA European Medicines Agency
CHMP Committee for Medicinal Products for Human Use
PRAC Pharmacovigilance Risk Assessment Committee
CMDh Coordination Group for Mutual Recognition and Decentralised Procedures – Human

Precise terminology is particularly important because similar abbreviations can be used differently in other regulatory contexts.

66. Key Takeaways

Centralised = one Union authorisation

National = one Member State

MRP = existing national authorisation recognised elsewhere

DCP = coordinated authorisation in several Member States without an existing EU national authorisation

References

  1. European Medicines Agency. Authorisation of medicines. EMA. Overview of the centralised procedure, national procedures, mutual recognition and decentralised procedures, including the common EU standards applicable across the different routes. 17

  2. European Medicines Agency. The European regulatory system for medicines. EMA. Explains the different routes to authorisation and the roles of EMA and national competent authorities. 18

  3. European Medicines Agency. Pre-authorisation guidance. EMA. Provides procedural guidance and identifies the EU regulatory framework, including Notice to Applicants chapters covering marketing authorisation, mutual recognition, Union referrals and variations. 19

  4. European Medicines Agency. Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Describes the role of CMDh in coordinating questions relating to marketing authorisations and variations under MRP and DCP. 20

  5. European Medicines Agency. Coordination Group for Mutual Recognition and Decentralised Procedures – Human: glossary definition. Provides the formal description of CMDh. 21

  6. European Parliament and Council. Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, as amended. In particular Articles 28 and 29 concerning mutual recognition, decentralised procedures and disagreement between Member States. 22

  7. European Medicines Agency. Referral procedures: human medicines. Provides the relationship between nationally authorised medicines, CMDh, PRAC and EU referral procedures. 23

  8. European Medicines Agency. Questions and answers: Article 30 referral procedures. Explains Article 30 referrals concerning divergent national decisions and harmonisation. 24

  9. European Parliament and Council. Regulation (EC) No 726/2004, as amended. Establishes Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products within its scope and the European Medicines Agency.

  10. European Commission. EudraLex — The rules governing medicinal products in the European Union. Provides the EU pharmaceutical legislative framework and regulatory guidance, including procedures for marketing authorisation.

  11. Heads of Medicines Agencies. CMDh procedural guidance. Provides practical guidance concerning mutual-recognition and decentralised procedures and related coordination activities.

Regulatory interpretation note

This article is an educational explanation of the principal EU marketing-authorisation routes. It does not replace Directive 2001/83/EC, Regulation (EC) No 726/2004, Commission decisions, EMA guidance, CMDh procedural guidance, national legislation or product-specific regulatory advice.

The precise eligibility and procedural requirements for a medicinal product must be determined from the legislation and current regulatory guidance applicable to that product.

The terms "centralised", "national", "mutual recognition" and "decentralised" describe regulatory procedures and should not be interpreted as different levels of scientific quality.

The simplified diagrams and decision trees are teaching aids rather than legal flowcharts.

In particular, the existence of a safety concern does not by itself determine whether Article 29, Article 30, Article 31, Article 107i or another procedure applies. The regulatory stage, authorisation route, legal basis and factual circumstances must be assessed together.

Because EU pharmaceutical legislation and procedural guidance evolve, current primary legislation and official EMA, European Commission and CMDh documentation should be consulted when making a regulatory decision.

Revision History

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