Centralised, National, Mutual Recognition and Decentralised Procedures Explained

1. Why the EU Has More Than One Marketing-Authorisation Route

The European Union does not use a single procedure for authorising every human medicinal product.

Medicines can enter the EU market through different regulatory routes because the legal framework distinguishes between products, authorisation circumstances and the level at which regulatory assessment and authorisation are to occur.

The four principal routes are:

1. the centralised procedure;
2. the national procedure;
3. the mutual recognition procedure (MRP);
4. the decentralised procedure (DCP).

These routes are sometimes presented as four ways of submitting the same application. That is misleading. They are different regulatory architectures.

They differ in who assesses the application, which authorities participate, where the resulting authorisation has effect, how disagreements are managed and which legal instruments govern the procedure.

Understanding those differences is essential before interpreting any EU marketing-authorisation history.

2. The First Question: Where Is the Medicine Being Authorised?

The starting point is not the name of the procedure. It is the intended regulatory scope.

A company may seek an authorisation:

• in one Member State;
• in several Member States through an MRP or DCP;
• throughout the Union through the centralised procedure, where that route applies.

The regulatory route follows from the legal framework and the circumstances of the application.

It is therefore useful to ask three questions in sequence:

1. Is the centralised procedure mandatory, available or inapplicable for this product?
2. If national authorisation is being pursued, is there already an authorisation in another Member State?
3. If several Member States are involved, is the product already authorised in one of them?

Those questions provide a practical way to distinguish the principal routes.

3. The Centralised Procedure

The centralised procedure is a Union procedure established under Regulation (EC) No 726/2004.

An application is assessed through the European medicines regulatory network, with the scientific assessment for human medicines conducted by the Committee for Medicinal Products for Human Use (CHMP) within its legal mandate.

Following the scientific assessment, CHMP adopts an opinion. For a centralised marketing authorisation, the European Commission subsequently adopts the legally operative Union decision.

The result is a single marketing authorisation valid throughout the EU and, under the applicable framework, the European Economic Area.

The centralised procedure therefore concentrates the scientific assessment and legal authorisation at Union level.

4. The Centralised Procedure Is Not Optional for Every Product

A common misconception is that a company can always choose between the centralised and national routes.

That is not correct.

EU legislation specifies categories of medicinal products for which the centralised procedure is mandatory. It also provides circumstances in which the procedure may be available for other products.

The eligibility rules have developed through successive amendments to EU pharmaceutical legislation.

Consequently, the correct question for a particular product is not simply, “Which procedure does the company prefer?” It is:

Which authorisation route does the applicable legislation permit or require for this medicinal product?

Eligibility should be established from the current legislation rather than inferred from how another product was authorised.

5. CHMP and the Scientific Assessment

CHMP is the EMA scientific committee responsible for medicinal products for human use within its mandate.

In the centralised procedure, the committee evaluates the application and considers whether the product meets the applicable requirements for quality, safety and efficacy.

The assessment is based on the submitted evidence and the applicable scientific and regulatory standards.

CHMP's conclusion is expressed through a scientific opinion.

That opinion is an important part of the centralised procedure, but it should not be confused with the European Commission's subsequent legal decision.

This distinction becomes particularly important when analysing the regulatory history of a centrally authorised product.

6. The European Commission Decision

For a centralised marketing authorisation, the scientific assessment does not itself create the marketing authorisation.

The regulatory sequence is broadly:

Marketing-authorisation application
              ↓
      Scientific assessment
              ↓
             CHMP
              ↓
        CHMP opinion
              ↓
   European Commission decision
              ↓
   Union marketing authorisation

The Commission decision is the legally operative act establishing the Union authorisation.

The precise procedural steps surrounding the decision are governed by the applicable legislation and procedures.

7. The National Procedure

The national procedure is used when a marketing authorisation is sought in a single Member State under the applicable national and EU framework.

The relevant national competent authority (NCA) conducts the assessment and grants the national marketing authorisation where the legal requirements are satisfied.

The authorisation is effective within that Member State.

National procedures therefore remain an important part of the EU medicines system even though EMA and Union-level procedures receive considerable attention.

The EU regulatory network is not a single central authority replacing the Member States. It is a distributed system in which national authorities retain substantial responsibilities.

8. National Authorisation Does Not Mean a Different Scientific Standard

A national marketing authorisation is not simply an authorisation subject to a lower scientific standard than a centralised authorisation.

EU pharmaceutical legislation establishes common requirements concerning the quality, safety and efficacy of medicinal products.

The distinction is principally one of regulatory route, authority and territorial scope, not a simple distinction between “high” and “low” scientific assessment.

The exact assessment process and documentation depend on the application and applicable procedure.

9. Why National Procedures Still Matter in the EU Network

National competent authorities perform functions that extend well beyond initial marketing authorisation.

They may be responsible for:

• national scientific expertise;
• inspections;
• pharmacovigilance activities;
• enforcement;
• participation in Union procedures;
• assessment of nationally authorised medicines;
• implementation of regulatory requirements.

National authorities also contribute experts to the European regulatory network.

The centralised and national parts of the system should therefore be viewed as interconnected rather than isolated.

10. Mutual Recognition Procedure

The Mutual Recognition Procedure (MRP) applies where a medicinal product already has a national marketing authorisation in one Member State and the applicant seeks recognition of that assessment in other Member States under the applicable legal framework.

The Member State whose existing assessment is relied upon is the Reference Member State (RMS).

The participating Member States in which recognition is sought are the Concerned Member States (CMSs).

The procedure is based on reliance upon an existing national assessment rather than starting an entirely new national assessment in every participating Member State.

11. The Reference Member State

The RMS has a coordinating role in the MRP.

It provides the assessment report and coordinates the procedure with the CMSs.

The RMS is not a European-level licensing authority. Its role arises from the legal architecture of the mutual-recognition procedure.

The distinction matters because the resulting authorisations remain national authorisations.

The RMS coordinates the scientific and procedural work; it does not transform the procedure into a centralised Union authorisation.

12. The Concerned Member States

CMSs participate in the MRP by reviewing the RMS assessment in the context of the proposed recognition.

The objective is mutual recognition of the existing assessment within the legal framework.

Where the participating authorities agree, the procedure proceeds toward national authorisations reflecting the outcome.

Where a significant disagreement remains, the applicable EU procedures provide mechanisms for resolving the dispute.

The presence of several authorities therefore does not mean that each Member State is conducting an entirely independent application assessment from the beginning.

13. Decentralised Procedure

The Decentralised Procedure (DCP) is used where the medicinal product has not yet received a national marketing authorisation in the participating Member States and the applicant seeks authorisation in more than one Member State simultaneously.

As in the MRP, one Member State acts as the RMS and the other participating Member States act as CMSs.

The major distinction is the starting point:

• MRP: an existing national authorisation is already present;
• DCP: no relevant national authorisation has yet been granted in the participating Member States.

The DCP therefore creates a coordinated assessment intended to lead to national authorisations in the participating Member States.

14. RMS Assessment in the DCP

During a DCP, the RMS coordinates preparation of the assessment and works with the CMSs.

The scientific assessment concerns the same core regulatory questions: whether the product meets the applicable requirements for quality, safety and efficacy.

The procedure is collaborative, but the resulting authorisations remain national.

This is one of the central concepts of the EU system:

A common or coordinated assessment does not necessarily produce a single Union marketing authorisation.

The legal route determines the nature of the final authorisation.

15. MRP and DCP Compared

The distinction is simple once the starting regulatory state is known.

The difficulty usually arises when the history of the product is not checked carefully.

16. Why the Starting State Matters

Consider two applications involving the same medicinal product.

In the first case, the product already has a national authorisation in Member State A and the company wants authorisation in Member States B and C. The legal situation points toward an MRP.

In the second case, the product has not yet been authorised in any of the participating Member States and the company seeks authorisation in A, B and C together. The relevant route is a DCP.

The scientific subject matter may be identical. The regulatory procedure is not.

17. What All Four Routes Have in Common

Although the routes differ substantially, they share important principles.

A medicinal product must satisfy the applicable legal requirements concerning matters such as:

• quality;
• safety;
• efficacy;
• benefit-risk balance;
• manufacturing;
• product information;
• pharmacovigilance obligations.

The route changes the regulatory architecture through which those requirements are assessed and the authorisation is established.

It does not remove the underlying need for an appropriate scientific and regulatory assessment.

18. The Territorial Scope of the Result

One of the easiest ways to distinguish the procedures is to ask where the resulting authorisation has legal effect.

This table is deliberately simplified. The detailed legal position depends on the applicable legislation, product category and procedure-specific circumstances.

Nevertheless, it provides the correct conceptual starting point.

19. The Role of Product Category

The choice of procedure is also influenced by the nature of the medicinal product.

Certain categories fall within mandatory centralised procedures under EU legislation. Other products may be authorised nationally or through MRP/DCP mechanisms, subject to the applicable rules.

For this reason, procedure selection should begin with the product's legal and regulatory classification.

A company's previous experience with another medicine does not establish the correct route for a new product.

20. A Practical Decision Tree

A useful first-pass decision framework is:

Is the centralised procedure mandatory or applicable?
                    │
              ┌─────┴─────┐
             Yes          No
              │            │
        Centralised    National route
                           │
                 More than one Member State?
                           │
                    ┌──────┴──────┐
                   No             Yes
                    │              │
                National      Existing national
                              authorisation?
                                  │
                           ┌──────┴──────┐
                          Yes            No
                           │              │
                          MRP            DCP

This is a conceptual decision tree, not a substitute for checking the legislation.

The next step in a real regulatory assessment is to verify eligibility and procedural requirements against the current legal framework.

21. What Happens During a Centralised Assessment?

A centralised application is evaluated through a structured scientific assessment coordinated by EMA.

The assessment considers the evidence submitted by the applicant against the applicable legal and scientific requirements. For a human medicine, CHMP is responsible for the scientific opinion within its mandate.

The assessment can involve questions to the applicant, review of responses and consideration of expert input.

The process is therefore not a single meeting at which a product is either accepted or rejected. It is a documented scientific evaluation that develops through successive assessment stages.

The final scientific conclusion must address whether the product satisfies the relevant requirements and whether its benefit-risk balance is favourable under the proposed conditions of use.

22. What Happens During an MRP or DCP?

MRP and DCP operate through cooperation between Member States.

The RMS prepares or coordinates the assessment, while CMSs participate according to the applicable procedure.

The objective is a common understanding of the scientific and regulatory assessment sufficient to support national authorisations in the participating Member States.

The procedures are therefore neither completely national nor equivalent to the centralised procedure.

They occupy a middle position: scientific work is coordinated across Member States, while the resulting marketing authorisations remain national.

23. Why the RMS Does Not Become the EU Regulator

The RMS is sometimes misunderstood as a European licensing authority.

It is not.

Its role is created by the MRP or DCP framework and concerns coordination of the assessment among the participating Member States.

The national competent authorities retain their legal responsibilities.

This distinction becomes especially important when a product has authorisations in several Member States. The presence of a common assessment report does not mean that the product has become centrally authorised.

24. Disagreement During MRP or DCP

The EU framework provides mechanisms for dealing with disagreement between Member States.

A disagreement may concern a substantive issue such as:

• quality;
• safety;
• efficacy;
• benefit-risk balance;
• a potential serious risk to public health.

The first objective is resolution within the applicable procedure.

If the disagreement cannot be resolved and the statutory conditions for escalation are met, the matter can proceed through the relevant Union referral mechanism.

The legal basis matters. Not every disagreement follows the same referral route.

25. Article 29(4) and Serious Risk to Public Health

Article 29(4) of Directive 2001/83/EC is an important example of escalation from the MRP/DCP framework.

Where Member States cannot reach agreement because of a potential serious risk to public health, the matter can enter a Union-level procedure under the conditions specified by the legislation.

This may lead to a CHMP assessment and a subsequent Union decision.

The procedure should not be described simply as “a CHMP referral.” Its identity comes from its legal basis and procedural history.

This distinction is important because Article 29(4), Article 30 and Article 31 procedures can all involve Union-level scientific assessment while addressing different legal questions.

26. The Role of CMDh

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) is a key component of the national-authorisation network.

It is concerned with the coordination of MRP and DCP procedures and with specified issues arising from nationally authorised human medicines.

CMDh is not the equivalent of CHMP.

CHMP operates as an EMA scientific committee for human medicines within its legal mandate, including centralised applications and specified Union procedures.

CMDh operates within the framework of national marketing authorisations and Member-State coordination.

The committee involved in a regulatory issue should therefore be identified from the legal procedure rather than from the general subject matter alone.

27. Product Information in MRP and DCP

A coordinated procedure can result in product information that is intended to be harmonised across the participating Member States, subject to the applicable legal and linguistic requirements.

The product information remains connected to national marketing authorisations.

This is different from the centralised procedure, where the marketing authorisation and associated Union product information form part of the centralised regulatory framework.

The distinction is important when determining who is responsible for implementation and which national regulatory acts are required.

28. Linguistic and National Implementation

For nationally authorised medicines, implementation involves national requirements in the relevant Member States.

The scientific assessment may be coordinated, but the final regulatory and linguistic steps remain linked to the national authorisations.

This is one reason a multi-country MRP or DCP can involve considerable implementation work even when the underlying scientific assessment is shared.

The regulatory outcome must ultimately be translated into the authorised national product information and other applicable national requirements.

29. The Centralised Route and Product Information

The centralised procedure produces a Union marketing authorisation with associated product information applicable within the scope of the authorisation.

The product information includes the Summary of Product Characteristics, labelling and package leaflet, subject to the applicable EU requirements.

Changes to centrally authorised product information are handled through the applicable centralised regulatory procedures.

The result is a different implementation architecture from that of a product authorised separately by several national authorities.

30. The Same Medicine Can Have Different Regulatory Histories

Two products containing the same active substance can have different regulatory histories.

One may have been centrally authorised.

Another may have been authorised nationally and subsequently expanded through MRP.

A third may have entered several markets through a DCP.

Consequently, regulatory professionals should not infer the procedure from the active substance, therapeutic area or commercial name.

The authorisation record must be checked.

31. The Difference Between Authorisation Route and Regulatory Procedure

The four routes discussed in this article describe the principal mechanisms by which a marketing authorisation is established.

They should not be confused with the many regulatory procedures that operate after authorisation.

For example, a centrally authorised medicine can subsequently undergo:

• variations;
• renewals where applicable;
• safety assessments;
• referrals;
• risk-management updates;
• post-authorisation studies.

Similarly, a nationally authorised medicine can be affected by national procedures or Union mechanisms applicable to nationally authorised products.

The initial authorisation route is therefore part of the product's regulatory history, not a permanent description of every subsequent procedure.

32. How to Identify the Authorisation Route From Regulatory Documents

When reviewing a product file, look for evidence such as:

• the marketing-authorisation decision;
• the procedure number;
• the RMS and CMS designations;
• EMA documentation;
• CHMP opinions;
• national competent-authority decisions;
• CMDh documents;
• the current product information.

A procedure number can be particularly informative because different regulatory systems use different identifiers.

However, the identifier should be interpreted in context rather than used as the sole basis for a legal conclusion.

33. Procedure Numbers and Regulatory History

A mature product may have multiple procedure numbers because different regulatory actions have occurred during its lifecycle.

For example, an initial DCP may be followed years later by several variation procedures and possibly a referral.

The existence of a later procedure number does not change the original authorisation route.

Instead, it records another regulatory event in the product's history.

A regulatory timeline should therefore distinguish the initial authorisation pathway from subsequent regulatory maintenance procedures.

34. Centralised Versus National: A Practical Comparison

This comparison is intentionally high-level. The precise legal arrangements depend on the medicine and the procedure.

35. MRP/DCP Versus Centralised: The Fundamental Difference

The most important distinction is not whether scientists in several countries participate.

It is the legal nature of the authorisation produced.

In a centralised procedure, the outcome is one Union marketing authorisation.

In MRP and DCP, the assessment is coordinated across Member States but the resulting authorisations are national.

That difference affects the regulatory documents, implementation pathway, maintenance procedures and interaction with national authorities.

36. Why the Distinction Matters for Pharmacovigilance

The authorisation route can affect how regulatory and pharmacovigilance information is handled.

A centrally authorised medicine sits within the Union centralised framework and is subject to the relevant EMA, PRAC and Commission processes.

A nationally authorised medicine may be managed through national competent authorities, CMDh mechanisms and, where applicable, Union pharmacovigilance procedures.

This does not mean that pharmacovigilance is “national” for one product and “European” for another. EU pharmacovigilance is a networked system.

The distinction concerns which legal and procedural structures apply to the particular regulatory action.

37. Why the Distinction Matters for Regulatory Affairs

Regulatory teams need to know the authorisation route because it affects questions such as:

• where a submission is made;
• which authority receives it;
• which committee assesses it;
• which decision establishes the change;
• how product information is updated;
• how changes are implemented across Member States.

An incorrect assumption about the authorisation route can therefore lead to the wrong regulatory procedure being selected.

38. Common Misunderstanding: “EMA Approved the Medicine”

For centrally authorised medicines, it is common in informal language to say that “EMA approved” the product.

This is imprecise.

EMA coordinates the scientific assessment and supports the relevant scientific committee. The CHMP adopts a scientific opinion. The European Commission adopts the legally operative centralised marketing-authorisation decision.

For a national, MRP or DCP authorisation, the legal structure is different again.

Precise regulatory language matters when documenting a decision or communicating its legal effect.

39. Common Misunderstanding: “RMS Approval Means EU Approval”

An RMS assessment or national authorisation does not automatically create a Union marketing authorisation.

In an MRP or DCP, the RMS has a coordinating role within a procedure involving the participating Member States.

The resulting national authorisations should not be described as a single EU marketing authorisation.

The terminology may seem semantic, but it reflects a real legal distinction.

40. Common Misunderstanding: “MRP and DCP Are the Same”

They share a common architecture but differ in the starting regulatory state.

MRP: the product already has a national authorisation that another Member State or Member States are asked to recognise.

DCP: the product has not yet received the relevant national authorisation in the participating Member States and is assessed through a coordinated procedure.

The difference is fundamental and should be established before interpreting the procedure history.

41. Common Misunderstanding: “National Means Outside EU Regulation”

National marketing authorisation does not mean that the product falls outside EU medicines law.

Member States operate within the EU pharmaceutical framework and apply national law implementing or supplementing applicable Union requirements.

The EU regulatory system deliberately combines Union rules with national regulatory responsibilities.

That combination is a defining characteristic of the system rather than an exception to it.

42. Choosing the Correct Regulatory Route

A regulatory professional assessing a new product should document the route-selection analysis.

At minimum, establish:

1. product classification;
2. applicable legal basis;
3. whether centralised authorisation is mandatory, available or excluded;
4. intended Member-State scope;
5. whether a national authorisation already exists;
6. the proposed RMS and CMS structure where applicable;
7. relevant procedural guidance;
8. any special legal requirements.

The conclusion should be supported by the current legislation rather than by precedent alone.

43. A Useful Regulatory Timeline

For teaching and internal planning, the lifecycle can be represented as:

Product development
        ↓
Route eligibility assessment
        ↓
Choice / requirement of procedure
        ↓
Marketing-authorisation application
        ↓
Scientific assessment
        ↓
Questions and responses
        ↓
Scientific conclusion
        ↓
Legal authorisation
        ↓
Implementation
        ↓
Post-authorisation lifecycle

The exact sequence and terminology vary by procedure.

The purpose of the model is to keep the scientific assessment, legal authorisation and subsequent maintenance conceptually separate.

44. The Route Does Not Determine the Benefit-Risk Outcome

The choice of procedure does not imply that a product will have a favourable or unfavourable benefit-risk balance.

The same scientific principles remain relevant regardless of the route, although the assessment structure and legal procedure differ.

Regulatory route and scientific outcome are therefore separate questions.

A centralised medicine is not inherently safer than a nationally authorised medicine merely because its authorisation was established at Union level.

Likewise, national authorisation does not imply a lower benefit-risk standard.

45. The Route Does Not End After Authorisation

Once authorised, the product enters its post-authorisation lifecycle.

The route remains relevant because it influences the legal framework under which later changes are processed, but it does not prevent the product from being subject to other EU procedures.

A nationally authorised medicine can become involved in a Union referral. A centrally authorised medicine can undergo a variation or safety assessment.

The regulatory system is therefore best understood as a set of interconnected procedures rather than four isolated pathways.

46. Practical Checklist

Before describing an EU medicine as “centrally authorised,” “nationally authorised,” “MRP” or “DCP,” verify:

• the original authorisation route;
• the legal basis;
• the Member States involved;
• whether an RMS was used;
• whether CMSs were involved;
• whether a Union marketing-authorisation decision exists;
• the current authorisation status;
• later procedures that may have altered the regulatory history.

This simple verification prevents a surprising number of regulatory-history errors.

47. The Core Distinction

The four routes can be reduced to one useful question:

Is the authorisation established as one Union authorisation, one national authorisation, or coordinated national authorisations?

From there:

• Centralised: one Union authorisation;
• National: one national authorisation;
• MRP: coordinated recognition of an existing national authorisation;
• DCP: coordinated assessment leading to national authorisations where no relevant prior national authorisation exists.

That is the foundation. The detailed legal rules determine when each route is available or required and how the procedure operates.

48. References

1. European Parliament and Council. Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended. Principal EU legislation governing national marketing authorisations, mutual recognition, decentralised procedures and related Union procedures for human medicines.
2. European Parliament and Council. Regulation (EC) No 726/2004, as amended. Establishes Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products and establishes the European Medicines Agency.
3. European Commission. Legal framework governing medicinal products for human use in the EU. Current Commission material describing the EU pharmaceutical legislative framework and the relationship between legislation and regulatory guidance. urlEuropean Commission — EU medicines legal frameworkhttps://health.ec.europa.eu/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu_en
4. European Commission. Authorisation procedures — the centralised procedure. Current Commission explanation of the centralised route, including its Union-level authorisation and scientific assessment architecture. urlEuropean Commission — centralised procedurehttps://health.ec.europa.eu/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu/authorisation-procedures-centralised-procedure_en
5. European Commission. Authorisation procedures — national authorisation procedures. Current Commission explanation of national, mutual recognition and decentralised procedures. urlEuropean Commission — national, MRP and DCP procedureshttps://health.ec.europa.eu/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu/authorisation-procedures-national-authorisation-procedures_en
6. European Medicines Agency. Authorisation of medicines. Current EMA overview of the centralised procedure, national procedures, MRP and DCP and the relationship between them. urlEMA — authorisation of medicineshttps://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
7. European Medicines Agency. Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh). Current information concerning CMDh's role in MRP/DCP procedures and nationally authorised medicines. urlEMA — CMDhhttps://www.ema.europa.eu/en/committees/working-parties-other-groups/coordination-group-mutual-recognition-decentralised-procedures-human-cmdh
8. European Commission. EudraLex Volume 2 — Notice to Applicants and regulatory guidelines. Current index of procedural and regulatory guidance for human medicines, including marketing authorisation and mutual-recognition material. urlEuropean Commission — EudraLex Volume 2https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-2_en
9. European Medicines Agency. Questions and answers: Article 29(4) referral procedures. Current explanation of the Article 29(4) legal basis and its relationship to unresolved MRP/DCP disagreement concerning a potential serious risk to public health. urlEMA — Article 29(4) referral Q&Ahttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-294-referral-procedures

Primary-document hierarchy

When determining the regulatory route or interpreting an individual procedure, the current legal and procedure-specific documents should take precedence over general explanations.

A practical hierarchy is:

1. applicable EU legislation and its current consolidated text;
2. the formal application and procedure-specific regulatory documents;
3. the legally operative marketing-authorisation decision or other final regulatory act;
4. adopted scientific opinions, positions or recommendations, where applicable;
5. assessment reports and annexes;
6. current EMA, European Commission and CMDh guidance;
7. secondary summaries and educational explanations.

The hierarchy is particularly important when a historical procedure is being reconstructed because guidance and web content may subsequently be revised.

Regulatory Note

This article is an educational and regulatory-reference document. It explains the principal EU routes for establishing marketing authorisations for human medicines and is intended to provide a conceptual foundation for more detailed articles on individual procedures.

It is not legal advice and should not be used as a substitute for the applicable EU legislation, current consolidated legal texts, EMA guidance, European Commission guidance, CMDh guidance, national competent-authority requirements or procedure-specific regulatory documents.

The EU medicines framework is subject to legislative and procedural change. The current applicable legal framework should therefore be checked whenever a live authorisation strategy or regulatory decision is being assessed.

The terms centralised, national, mutual recognition and decentralised describe distinct regulatory architectures. They should not be used interchangeably, and the exact legal position for a particular product should be established from its regulatory record.

This article deliberately distinguishes the initial marketing-authorisation route from subsequent regulatory procedures. A product's later variations, referrals, safety assessments or other regulatory actions do not necessarily alter the route through which its original marketing authorisation was established.

Where an individual procedure is being assessed, the current applicable legislation and the formal documents governing that procedure take precedence over this general explanation.