Decentralised Procedure (DCP): How It Works

Introduction

The Decentralised Procedure (DCP) is one of the principal European procedures for obtaining national marketing authorisations for a medicinal product in more than one Member State when the product does not already have a marketing authorisation in the participating Member States.

DCP is therefore a national-authorisation procedure with a coordinated European assessment. It should not be confused with the centralised procedure, which produces a single Union marketing authorisation, or with the Mutual Recognition Procedure (MRP), which starts from an existing national marketing authorisation.

The basic architecture is straightforward:

Applicant
   |
   v
Common application in participating Member States
   |
   v
Reference Member State (RMS)
   |
   v
Scientific assessment
   |
   +-------------------+
   |                   |
   v                   v
Concerned Member    RMS assessment
States (CMSs)       report / draft texts
   |                   |
   +---------+---------+
             |
             v
        Coordinated assessment
             |
             v
       Agreement reached?
          /       \
        Yes        No
         |          |
         v          v
 National MAs    CMDh / possible
                 Article 29(4)

The detailed roles of RMS and CMS are addressed separately in Reference Member State (RMS) and Concerned Member States (CMS): Roles and Responsibilities. The disagreement pathway is addressed in What Happens When Member States Disagree During an MRP or DCP?

The purpose of this article is to explain the DCP itself: why it exists, when it is used, how the procedure progresses, what the applicant and Member States are trying to achieve at each stage, and how the coordinated procedure ultimately results in national marketing authorisations.

1. What Is the Decentralised Procedure?

The DCP is a procedure under which an applicant simultaneously seeks marketing authorisation for a medicinal product in two or more Member States where the product has not already been authorised in those Member States, with one Member State acting as the Reference Member State (RMS) and the others participating as Concerned Member States (CMSs).

The RMS coordinates the scientific assessment and prepares the assessment documentation used during the procedure.

The CMSs participate in the assessment and consider the RMS's work within the common regulatory framework.

The objective is not for one national authority to issue a European authorisation. The objective is to conduct a coordinated assessment that can support national marketing authorisation decisions in the participating Member States.

This distinction is fundamental:

DCP coordinates the assessment; the resulting marketing authorisations remain national authorisations.

2. DCP Compared With MRP

DCP and MRP are closely related but begin from different regulatory states.

The distinction is not merely terminology.

In DCP, the participating authorities assess an application as part of the initial authorisation process. In MRP, the participating authorities are asked to recognise an existing national authorisation under the mutual-recognition framework.

The separate article on MRP examines that process in detail.

3. When Is DCP Used?

DCP is used when an applicant wants to obtain national marketing authorisations in several Member States through a coordinated procedure and there is no existing national marketing authorisation for the relevant product in those participating Member States.

The procedure is particularly important for products that are authorised through national routes rather than through the centralised procedure.

Whether DCP is legally available depends on the product, its regulatory characteristics and the applicable legislation.

The choice of procedure should therefore not be made simply because an applicant wants several national authorisations. The legal eligibility of the product and the applicable Union requirements must first be established.

4. Choosing the Participating Member States

The applicant identifies the Member States in which it seeks national marketing authorisations through the DCP.

One of the participating Member States acts as RMS. The remaining participating Member States act as CMSs.

The selection of the RMS is important because that authority coordinates the assessment and prepares the core assessment documentation.

The participating authorities nevertheless remain national competent authorities. DCP does not transfer their legal identity or convert them into branches of the RMS.

The procedural cooperation therefore has to be understood as coordination between competent authorities under a common legal framework, rather than as a hierarchical relationship in which the RMS becomes the regulator of the CMSs.

5. The Application and Common Dossier

The applicant submits the marketing authorisation application in accordance with the requirements applicable to DCP.

The scientific dossier is structured according to the Common Technical Document framework and applicable European requirements.

The same underlying application supports the coordinated assessment, although national administrative and product-information requirements can still need to be addressed according to the applicable procedure.

At this stage, the applicant should ensure that the dossier is internally coherent across all participating Member States.

Differences in proposed product information, administrative data or national implementation requirements should be identified and controlled rather than emerging unexpectedly during the assessment.

The RMS and CMSs then validate the application according to the applicable procedural requirements.

6. Validation Before Scientific Assessment

Validation is distinct from the scientific assessment itself.

The authorities first determine whether the application satisfies the procedural and administrative requirements necessary for the assessment to proceed.

Issues at validation can include matters such as completeness of the application, required documentation and procedural prerequisites.

The precise validation requirements depend on the application and current procedural guidance.

For regulatory professionals, the important distinction is:

Validation
   ↓
Can the application enter the procedure?

Scientific assessment
   ↓
Does the evidence support authorisation?

A validated application is not an approved application. Validation simply establishes that the application can proceed into the substantive assessment according to the applicable procedure.

7. The RMS Scientific Assessment

The RMS coordinates the scientific assessment of the application.

The assessment considers the evidence supporting the proposed marketing authorisation, including the quality, safety and efficacy of the medicinal product and the resulting benefit-risk balance.

The RMS prepares the relevant assessment documentation for circulation to the CMSs.

The assessment should provide a reasoned scientific basis for the regulatory conclusions rather than simply reproducing the applicant's dossier.

The CMSs then review the assessment within the DCP framework.

This is one of the most important features of the procedure: the RMS prepares the assessment, but the CMSs are not expected simply to accept it without scrutiny.

8. What the CMSs Do During Assessment

CMSs review the RMS assessment and the underlying application according to their responsibilities within the procedure.

They can identify questions, request clarification and raise concerns where the available evidence does not adequately support the proposed conclusion.

This is a collaborative scientific process, but collaboration does not mean that all authorities must initially interpret every aspect of the evidence in exactly the same way.

Differences are expected to be examined through the procedural mechanisms available within DCP.

The aim is to reach a common regulatory conclusion that can support national authorisations in the participating Member States.

9. The Assessment Report as the Regulatory Backbone

The RMS assessment report is central to the DCP.

It should explain the scientific reasoning supporting the proposed conclusions and identify the basis for the proposed product information and other regulatory elements.

For the applicant, the assessment report is more than a procedural document. It provides an important record of how the authorities understood the evidence.

The applicant should therefore review the assessment carefully and distinguish between:

• factual statements;
• descriptions of the evidence;
• scientific conclusions;
• identified uncertainties;
• outstanding questions; and
• proposed regulatory measures.

A response that merely repeats the dossier without addressing the assessor's reasoning is unlikely to resolve a substantive question.

10. Questions, Comments and Scientific Discussion

During the DCP, the applicant may receive questions or comments requiring clarification or additional information.

The applicant should manage these responses as a controlled regulatory submission.

A strong response should identify the question, provide the requested evidence, explain the scientific interpretation and acknowledge limitations where they remain.

The applicant should avoid treating every regulatory question as an adversarial challenge. The purpose of the exchange is to establish whether the evidence supports the proposed authorisation and conditions of use.

At the same time, an applicant should not conceal genuine scientific disagreement behind vague language. Where evidence can reasonably support more than one interpretation, the competing interpretations and their implications should be explained clearly.

11. Product Information During the DCP

Product information is an integral part of the regulatory assessment.

The proposed Summary of Product Characteristics (SmPC), package leaflet and labelling must be consistent with the scientific conclusions and applicable requirements.

The RMS and CMSs consider the proposed product information within the DCP framework.

Differences between Member States may arise from national implementation requirements, but the scientific core of the product information is coordinated through the procedure.

The regulatory professional should therefore avoid treating product information as an administrative document prepared only after the scientific assessment. It is part of the authorisation package and reflects the conclusions of the assessment.

12. Risk Management and Pharmacovigilance

The DCP assessment also considers the pharmacovigilance and risk-management arrangements relevant to the application.

Depending on the product and applicable requirements, this can include consideration of the pharmacovigilance system, risk-management plan and proposed risk-minimisation measures.

The exact requirements depend on the product and legal framework.

The key principle is that authorisation assessment and pharmacovigilance are connected. The regulatory system must establish not only whether the medicine can be authorised but also how important risks will be monitored and managed after authorisation.

This becomes particularly relevant once the national authorisations are granted and the product enters its post-authorisation lifecycle.

13. Reaching Agreement

The central procedural objective of the DCP is agreement among the participating Member States on the assessment and the regulatory basis for the national authorisations.

Agreement does not mean that every assessor has identical internal scientific views on every detail. It means that the authorities reach the regulatory conclusion required to proceed within the DCP framework.

Where substantive concerns remain, the procedure provides mechanisms for resolving them.

The applicant should therefore understand two different questions:

1. Is the scientific issue resolved?
2. Has the regulatory disagreement been resolved sufficiently for the procedure to proceed?

These questions are related but not always identical.

14. What Happens When Agreement Cannot Be Reached?

A disagreement during DCP can become significant when a Member State considers that the application may pose a potential serious risk to public health or when another legally relevant ground prevents agreement under the applicable framework.

The matter can move into the coordination mechanisms involving the CMDh.

If the disagreement remains unresolved in the circumstances specified by EU law, the matter can be referred for Union-level arbitration under the Article 29(4) mechanism.

The detailed disagreement pathway is deliberately not reproduced here. It is the subject of the dedicated articles:

• What Happens When Member States Disagree During an MRP or DCP?
• Potential Serious Risk to Public Health in EU Marketing Authorisation Procedures
• the existing dedicated Article 29(4) article.

This boundary is important because DCP itself should not be confused with the subsequent dispute-resolution procedure.

15. From DCP Agreement to National Authorisations

Once the DCP reaches the appropriate agreed conclusion, the participating Member States proceed toward granting the national marketing authorisations under their national legal frameworks and the applicable EU procedure.

The result is therefore a set of national marketing authorisations rather than one centralised Union authorisation.

The national authorisations are based on the common assessment and agreed regulatory outcome, subject to the applicable national procedural steps.

This is the point at which the distinction between assessment coordination and legal authorisation becomes particularly clear.

The RMS coordinates the scientific assessment, but the resulting authorisations are granted within the national legal systems of the participating Member States.

16. DCP Does Not End at the Grant of the Authorisation

The DCP establishes the regulatory foundation for the product's subsequent lifecycle in the participating Member States.

After authorisation, the product may undergo:

• variations;
• renewals where applicable;
• safety-related regulatory changes;
• risk-management activities;
• additional pharmacovigilance activities;
• transfers or other lifecycle procedures; and
• other post-authorisation regulatory actions.

Many of these activities continue to use coordinated EU procedures.

The DCP should therefore be understood as the beginning of a coordinated national-authorisation lifecycle rather than as an isolated application event.

17. The Regulatory History of a DCP Product

For a regulatory professional reviewing a product, the DCP history should be reconstructed in sequence.

A useful model is:

Product eligibility
       ↓
Participating Member States selected
       ↓
RMS selected
       ↓
Application submitted
       ↓
Validation
       ↓
RMS assessment
       ↓
CMS review
       ↓
Questions / clarification
       ↓
Agreement
       ↓
National authorisations
       ↓
Post-authorisation lifecycle

If disagreement occurs, the sequence branches into the CMDh and potentially Union referral pathway.

Understanding this history is essential when interpreting later variations, safety referrals or changes to the product information.

Key Takeaways

1. The DCP is a coordinated procedure for obtaining national marketing authorisations in two or more Member States when the relevant product is not already authorised in those participating Member States.
2. One participating Member State acts as RMS and the others as CMSs.
3. The RMS coordinates the scientific assessment and prepares the core assessment documentation.
4. CMSs independently review the assessment within the DCP framework and can raise questions or concerns.
5. DCP produces national marketing authorisations; it does not create a centralised Union marketing authorisation.
6. DCP differs from MRP primarily because DCP starts without an existing relevant national marketing authorisation, whereas MRP starts from an existing national authorisation.
7. Validation and scientific assessment are separate stages.
8. The assessment report provides an important record of the scientific reasoning supporting the regulatory conclusion.
9. Product information, pharmacovigilance and risk-management arrangements form part of the authorisation framework rather than being purely post-approval administrative matters.
10. The objective is agreement among the participating Member States, not necessarily identical scientific opinions on every detail.
11. Where legally significant disagreement persists, the procedure can move into CMDh coordination and, where the statutory conditions are met, Article 29(4) referral.
12. The national authorisations granted after DCP remain part of the coordinated European regulatory network.
13. The DCP is the starting point of a product's national-authorisation lifecycle, not the end of regulatory oversight.

References

1. European Parliament and Council. Directive 2001/83/EC on the Union code relating to medicinal products for human use, as amended. Primary legal basis for national marketing authorisation procedures, including the decentralised and mutual recognition procedures and the associated disagreement mechanisms.
2. Heads of Medicines Agencies / CMDh. DCP (Decentralised Procedure). Current procedural guidance, standard operating procedures, assessment-report templates and RMS-related material for human medicines.
3. Heads of Medicines Agencies / CMDh. Application for Marketing Authorisation. Current guidance concerning applications, validation and procedural requirements for MRP and DCP.
4. European Medicines Agency. Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Current description of CMDh's role in DCP/MRP and related questions.
5. European Commission. EudraLex Volume 2A — Procedures for marketing authorisation. Current Union procedural framework and Notice to Applicants material.
6. European Commission. EudraLex Volume 2B — Presentation and content of the dossier. Common Technical Document framework relevant to marketing authorisation applications.

Regulatory Note

This article is an educational explanation of the Decentralised Procedure for human medicinal products in the EU. It is not legal advice and does not replace the current consolidated text of Directive 2001/83/EC, applicable national legislation, CMDh procedural guidance, current European Commission guidance or the documents governing an individual DCP.

The precise procedural requirements, validation arrangements, assessment steps, submission dates, product-information requirements and national implementation steps can change. Current procedure-specific guidance should therefore be checked for a live application.

The article deliberately separates DCP itself from the dedicated RMS/CMS, disagreement, potential-serious-risk-to-public-health and Article 29(4) articles. Those articles provide greater detail on specific aspects of the framework and should not be interpreted as additional stages that occur in every DCP.

A DCP does not itself grant a single Union marketing authorisation. Its coordinated assessment provides the basis for national marketing authorisations in the participating Member States under the applicable legal framework.

18. The Applicant's Perspective: Managing a DCP as One Regulatory Process

Although the DCP involves several national competent authorities, the applicant should manage it as a single coordinated regulatory process rather than as a collection of unrelated national submissions. The scientific position presented to the RMS and CMSs should remain coherent throughout the procedure, while genuine national differences should be identified and controlled explicitly.

A useful internal model is to maintain a controlled record linking the dossier, questions, responses, assessment conclusions, product information and national implementation. This makes it possible to distinguish what was agreed during the common procedure from what was subsequently implemented nationally.

The applicant also needs to maintain a clear distinction between the regulatory position and internal assumptions. An issue that appears minor during the initial assessment can become important later if it affects product information, risk management, manufacturing arrangements or the interpretation of a subsequent variation.

19. Reading the DCP From a Regulatory-Affairs Perspective

A DCP file should be read as a sequence of regulatory decisions rather than simply as a collection of documents.

The key questions are:

1. What was the regulatory starting position?
2. Which Member State acted as RMS and which participated as CMSs?
3. What scientific assessment did the RMS make?
4. What questions or concerns did the CMSs raise?
5. How did the applicant respond?
6. What conclusions were reached?
7. What product information was agreed?
8. How were national marketing authorisations subsequently implemented?

This approach is particularly useful when a product is inherited by a new regulatory team. The current authorisation should be understood in the context of the assessment and decisions that produced it.

20. DCP and the Product's Regulatory Identity

The outcome of a DCP creates a common scientific and regulatory foundation, but the participating marketing authorisations remain national. The regulatory identity of the product therefore has both a coordinated European history and country-specific legal manifestations.

This distinction matters when reviewing a product portfolio. The same medicinal product may have closely aligned authorised information across Member States while still having separate national marketing authorisation records and national regulatory histories.

The regulatory professional should therefore avoid treating the DCP procedure number as if it were itself the marketing authorisation. The procedure records the coordinated assessment; the national authorisations are the legally operative authorisations in the participating Member States.

21. DCP and Subsequent Regulatory Changes

Once the product is authorised, subsequent changes must be managed under the applicable post-authorisation framework. The fact that the original authorisation arose from a DCP does not mean that every later change follows the same procedural mechanism.

A regulatory change may involve a variation, a renewal where applicable, a safety-related procedure, an extension or another regulatory mechanism. The correct route depends on the nature of the change and the applicable legislation and guidance.

The DCP history remains important because later regulators and regulatory teams may need to understand the scientific and regulatory basis for the current authorised position.

The broader post-authorisation lifecycle is addressed in How an EU Marketing Authorisation Is Maintained After Approval.

22. DCP and Pharmacovigilance Oversight

From a pharmacovigilance perspective, the DCP creates an important regulatory baseline. The authorised product information and any risk-management commitments established through the procedure form part of the information against which subsequent safety information is interpreted.

A QPPV or PV organisation should therefore be able to identify the regulatory outcome of the DCP and understand how safety-relevant conclusions were incorporated into the authorised framework.

This does not mean that the QPPV becomes responsible for the entire DCP. Rather, the pharmacovigilance organisation needs appropriate interfaces with regulatory affairs so that safety-relevant regulatory decisions are understood, implemented and traceable.

The same principle applies in reverse: emerging pharmacovigilance information may subsequently lead to regulatory action affecting the national authorisations established through the DCP.

23. Why DCP Is a Coordinated Procedure Rather Than a Single EU Authorisation

The terminology can obscure the legal structure. The DCP is European in its coordination and legal framework, but its authorisation outcome remains national.

The RMS coordinates the assessment and the CMSs participate under the common procedure. Once the procedure has reached the required conclusion, the participating national authorities grant the relevant national marketing authorisations through their legal systems.

This is fundamentally different from the centralised procedure, where the applicable Union process culminates in a European Commission decision granting a Union marketing authorisation.

The distinction should be retained throughout the product lifecycle because it affects the legal basis for subsequent regulatory actions.

24. DCP Versus MRP: The Practical Decision Point

For regulatory planning, the most useful initial distinction between DCP and MRP is the status of the product before the procedure begins.

If the relevant product already has a national marketing authorisation that can serve as the basis for recognition in additional Member States, MRP may be the applicable route. If the relevant product does not already have the relevant national authorisation in the participating Member States, DCP may provide the coordinated route, subject to legal eligibility.

This distinction should always be checked against the current legislation and procedural guidance rather than used as a substitute for a formal eligibility assessment.

25. A Practical DCP Control Framework

A regulatory organisation can use the following conceptual control framework:

Eligibility
   ↓
Procedure strategy
   ↓
RMS / CMS selection
   ↓
Application readiness
   ↓
Validation
   ↓
Scientific assessment
   ↓
Questions and responses
   ↓
Agreement / disagreement management
   ↓
National authorisation
   ↓
Controlled implementation
   ↓
Lifecycle maintenance

At each stage, the organisation should be able to identify the responsible function, the governing document, the current regulatory position and the evidence supporting that position.

This is particularly important for products with long regulatory histories. Without controlled traceability, later teams may know the current wording of the authorisation without understanding why that wording exists.

26. Common DCP Misinterpretations

DCP creates one European marketing authorisation

It does not. The procedure produces national marketing authorisations in the participating Member States.

The RMS is the regulator of the CMSs

The RMS coordinates the procedure but does not become the superior national authority of the CMSs.

CMSs simply endorse the RMS assessment

CMSs participate in the scientific and regulatory assessment and can raise questions or concerns within the applicable framework.

Validation means the product has been scientifically accepted

Validation establishes that the application can proceed through the relevant procedure. It is not a scientific conclusion on the benefit-risk balance.

DCP and MRP are interchangeable

They share important structural features but begin from different regulatory positions and serve different purposes.

The procedure ends when the common assessment ends

The national authorisations and their subsequent lifecycle remain subject to regulatory management after the coordinated assessment concludes.

The QPPV owns the DCP because pharmacovigilance is involved

The QPPV's responsibility concerns pharmacovigilance oversight. Ownership of the broader regulatory procedure depends on the organisation's governance and assigned responsibilities.

Key Takeaways

1. DCP is a coordinated European procedure that results in national marketing authorisations.
2. The RMS coordinates the assessment; CMSs participate in the assessment within their defined roles.
3. The applicant should manage the procedure as one controlled regulatory process while preserving the distinction between common assessment and national implementation.
4. The assessment report and regulatory correspondence provide important evidence of how the authorised position was established.
5. DCP and MRP should be distinguished primarily by their regulatory starting positions and purposes.
6. The DCP history remains relevant throughout the product lifecycle.
7. Regulatory Affairs and Pharmacovigilance need effective interfaces, particularly where DCP conclusions affect safety information or risk management.
8. The legally operative authorisations after DCP remain national.
9. Subsequent regulatory changes must be assessed under the applicable post-authorisation framework rather than assumed to follow the original DCP route.
10. A controlled regulatory history is essential for understanding and maintaining the product's current authorised position.

References

1. European Parliament and Council. Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended. Principal Union legislation governing national marketing authorisation procedures, including decentralised and mutual recognition procedures.
2. CMDh. Current guidance and procedural documents for Decentralised Procedures. Procedural material concerning DCP organisation, RMS/CMS participation, assessment and national implementation.
3. European Commission. EudraLex, Volume 2A — Procedures for marketing authorisation. Union procedural guidance and Notice to Applicants material.
4. European Commission. EudraLex, Volume 2B — Presentation and content of the dossier. Common Technical Document framework for marketing authorisation applications.
5. European Medicines Agency. Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Current information concerning CMDh's role and the coordination of nationally authorised medicines.
6. European Medicines Agency. European regulatory system for medicines. Current explanatory material concerning the relationship between national competent authorities and the European regulatory network.

Regulatory Note

This article is an educational explanation of the EU Decentralised Procedure for human medicinal products. It does not constitute legal advice and does not replace the current consolidated legislation, CMDh procedural guidance, European Commission guidance, national requirements or procedure-specific regulatory documents.

Regulatory procedures and guidance can change. For a live DCP, the current legal framework and applicable procedure-specific documents should be consulted.

The article deliberately separates the DCP itself from the detailed allocation of RMS and CMS responsibilities and from the formal disagreement and Article 29(4) processes. Those subjects are addressed in dedicated articles in this series.

Where a specific regulatory action is being planned or assessed, the applicable legislation and formal regulatory documents take precedence over this general educational explanation.