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How the EU Centralised Marketing Authorisation Procedure Works

How a medicinal product moves through the EU centralised marketing authorisation procedure, including eligibility, pre-submission activities, validation and the start of scientific assessment.

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How the EU Centralised Marketing Authorisation Procedure Works

Introduction

The EU centralised marketing authorisation procedure is the Union route through which eligible medicinal products for human use are evaluated through a single EU procedure and, when authorised, receive a single marketing authorisation valid across the Union market.

It is often reduced to the phrase “EMA assesses the medicine and the European Commission approves it”. That description is useful as a starting point, but it hides the regulatory work between those stages. The procedure includes eligibility, pre-submission planning, scientific assessor appointment, dossier submission, validation, multidisciplinary assessment, questions to the applicant, consideration of pharmacovigilance and risk management, adoption of a CHMP scientific opinion and subsequent European Commission decision-making.

This article follows that process in sequence. It deliberately does not repeat the broad comparison of centralised, national, mutual recognition and decentralised procedures in Centralised, National, Mutual Recognition and Decentralised Procedures Explained. The distinction between the CHMP scientific opinion and the Commission's legally operative decision is examined separately in CHMP Scientific Opinions and European Commission Marketing Authorisation Decisions, while post-authorisation maintenance is covered in How an EU Marketing Authorisation Is Maintained After Approval.

1. What the Centralised Procedure Is

The centralised procedure is established principally by Regulation (EC) No 726/2004.

Its defining feature is that an eligible medicinal product is evaluated through a Union procedure rather than through separate national marketing-authorisation applications in each Member State.

The resulting centralised marketing authorisation is valid throughout the EU and, under the applicable framework, the European Economic Area (EEA).

The procedure therefore combines:

This does not mean that EMA itself is the legal authorising body. EMA coordinates and supports the scientific and regulatory process, CHMP adopts the scientific opinion, and the European Commission adopts the legally binding marketing-authorisation decision.

2. Who Is Involved?

Several actors contribute to the centralised procedure, and their functions should not be conflated.

Actor Core function
Applicant Submits the application and provides evidence and responses during assessment
EMA Coordinates the procedure and provides scientific and regulatory support
CHMP Conducts the principal scientific assessment for human medicines and adopts the scientific opinion
Rapporteurs Lead preparation of the scientific assessment for CHMP
PRAC Provides relevant pharmacovigilance and risk-management input within its remit
CAT Performs the relevant assessment role for advanced therapy medicinal products within its remit
European Commission Adopts the legally binding Union marketing-authorisation decision
National competent authorities Provide experts and participate in the European regulatory network

The centralised procedure is therefore a networked regulatory process, not a simple hierarchy in which one organisation performs every task.

3. Is the Product Eligible for the Centralised Procedure?

The centralised procedure is not an optional route for every medicinal product.

Regulation (EC) No 726/2004 establishes categories for which the procedure is mandatory and circumstances in which it may be available under the applicable provisions. Current EMA guidance distinguishes mandatory and optional scope and asks applicants to submit an eligibility request with justification before a centralised application is submitted.

Eligibility must therefore be established from the current legislation and applicable EMA procedure, rather than inferred from the regulatory history of another medicine.

The first regulatory question is consequently:

Is the centralised procedure legally applicable to this medicinal product?

For products in optional scope, the applicant must also satisfy the conditions applicable to that route.

4. Eligibility Is More Than an Administrative Check

Eligibility determines whether the Union centralised framework can be used for the application.

EMA's current pre-authorisation guidance states that eligibility requests are assessed case by case where applicable. The applicant therefore needs a defensible regulatory justification rather than merely a statement that the product belongs to a particular therapeutic category.

A useful conceptual sequence is:

Product characteristics
        ↓
Applicable legal provision
        ↓
Mandatory or optional scope?
        ↓
Eligibility established
        ↓
Centralised application planning

Eligibility provisions have evolved with EU legislation. For a live application, the current consolidated Regulation (EC) No 726/2004 and current EMA eligibility guidance take precedence over any general description.

5. Pre-Submission Planning

A substantial part of the centralised procedure occurs before formal submission.

EMA's current pre-authorisation guidance covers eligibility, notification of the intended submission date, appointment of rapporteurs and pre-submission interactions.

The applicant should establish, among other matters:

These activities improve regulatory preparedness but do not predetermine the scientific outcome.

6. Notification of Intention to Submit

Applicants notify EMA of their intention to submit a marketing authorisation application according to the current pre-submission arrangements.

This enables EMA to plan the procedure and the necessary scientific and regulatory resources.

Current EMA guidance indicates that the intended submission date is notified approximately seven months before submission, subject to the applicable procedural instructions.

This is an operational requirement that should be checked against current EMA guidance because forms, submission arrangements and procedural instructions can change.

7. Appointment of Rapporteurs

The scientific assessment is prepared through designated assessors rather than by every CHMP member independently reviewing the entire dossier from the outset.

CHMP appoints rapporteurs, and where applicable co-rapporteurs, to lead preparation of the scientific assessment for the committee. PRAC appoints rapporteurs for relevant pharmacovigilance aspects. For advanced therapy medicinal products, CAT has the relevant assessment role under the applicable framework.

Rapporteurs are therefore central to the practical scientific work, but they do not replace the committees. Their assessment is developed for consideration by the relevant committee, which adopts the scientific conclusion within its legal mandate.

8. Pre-Submission Meetings

EMA recommends pre-submission interactions so applicants can obtain procedural and regulatory advice before filing the application.

Such interactions can address dossier readiness, procedural questions, submission logistics and product-specific regulatory issues.

A pre-submission discussion is not scientific approval of the future application. Advice received before submission should not be interpreted as a commitment by EMA or CHMP to reach a particular conclusion.

The purpose is to improve regulatory preparedness and clarify procedural expectations before formal assessment begins.

9. Preparing the Marketing Authorisation Application

The application must contain the evidence and regulatory documentation required by the applicable EU pharmaceutical legislation and procedural requirements.

The dossier provides the scientific basis for the proposed authorisation, including quality, non-clinical and clinical evidence together with the required product-information and pharmacovigilance documentation.

For centralised applications, the current EMA requirements specify the electronic Common Technical Document (eCTD) as the electronic submission format.

The objective is not simply to submit a large quantity of information. The dossier must allow assessors to determine whether the medicinal product satisfies the applicable requirements and whether its benefit-risk balance is favourable under the proposed conditions of use.

10. Submission to EMA

The application is submitted to EMA through the applicable electronic submission process.

Current EMA guidance specifies eCTD for centralised applications and describes the relevant electronic submission arrangements.

Submission is the formal entry of the dossier into the regulatory process, but scientific assessment does not simply begin at the instant the files arrive. The application first undergoes validation.

11. Validation: Is the Application Ready to Be Assessed?

Validation determines whether the application contains the essential elements required for scientific assessment to begin.

EMA describes two important aspects:

  1. technical validation, concerning the structure and technical compliance of the electronic submission; and
  2. regulatory and administrative content validation, concerning whether the required elements of the application are present.

Validation is therefore not the scientific assessment.

An application can pass validation and subsequently raise major scientific questions. Conversely, a validation problem says nothing by itself about whether the medicine has a favourable or unfavourable benefit-risk balance.

It is a gateway question:

Is the application sufficiently compliant and complete for the formal scientific procedure to proceed?

12. When Does the Scientific Procedure Start?

Once the application has completed the applicable validation process, EMA starts the centralised procedure according to the published procedural schedule.

Under the standard framework, the CHMP opinion is to be given within a maximum of 210 days of active assessment, excluding applicable periods during which the clock is stopped while the applicant provides answers to questions or additional information.

The 210-day framework is therefore not necessarily 210 consecutive calendar days from submission to opinion. The actual calendar duration depends on assessment periods, clock stops and any applicable procedural arrangements.

The current EMA procedural timetable and procedure-specific communications should always be used for a live application.

References for this section

The principal sources for this article are Regulation (EC) No 726/2004 and the current EMA Pre-authorisation guidance for users of the centralised procedure, including its sections on eligibility, pre-submission activities, submission, validation and assessment. The current EMA Obtaining an EU marketing authorisation — step-by-step page provides the public procedural overview.

The next chunk follows the application through detailed scientific assessment, questions and responses, pharmacovigilance and risk management, benefit-risk assessment, CHMP opinion and the European Commission decision.

13. Scientific assessment: from dossier to regulatory questions

Once the application has entered the formal procedure, the work changes from regulatory preparation to detailed scientific assessment. The dossier is examined by multidisciplinary assessment teams supporting the CHMP, with the rapporteurs coordinating the principal assessment work.

The assessment is not a single review of whether the applicant's conclusions are acceptable. Assessors examine the underlying evidence and the reasoning connecting that evidence to the proposed conditions of use.

Depending on the product, questions may concern:

The assessment therefore tests both the evidence and the applicant's interpretation of it.

A useful distinction is between data, analysis and regulatory conclusion. The applicant may provide a large amount of data, but the committee must determine what those data establish, what remains uncertain and whether the resulting benefit-risk balance supports the proposed authorisation.

14. Rapporteur assessment reports

The rapporteurs coordinate preparation of assessment reports for consideration by the relevant scientific committee. The reports provide a structured scientific analysis of the application and identify issues requiring discussion or clarification.

The assessment report is not itself the marketing authorisation decision. It is part of the scientific process through which the committee develops its opinion.

This distinction is important when reading regulatory documents. A statement in a rapporteur report may describe an assessment team's concern, interpretation or preliminary conclusion. It should not automatically be treated as the final position of CHMP.

The regulatory history should therefore be read in sequence: assessment reports and questions show the development of the scientific assessment, while the adopted CHMP opinion represents the committee's formal scientific conclusion.

15. The List of Questions

During the assessment, CHMP considers the scientific issues identified by the assessment teams and may adopt a List of Questions (LoQ) for the applicant.

The questions can range from requests for clarification to substantial requests for additional analyses or justification.

A question should be understood in the context of the assessment rather than as a simple request for missing paperwork. For example, an assessor may question the robustness of an efficacy analysis, the interpretation of a safety imbalance, the adequacy of a proposed risk-minimisation measure or the justification for a particular wording in the product information.

The applicant's response is therefore part of the scientific dialogue of the procedure. It can provide additional evidence, analyses, explanations or proposed amendments to the dossier.

The current EMA standard timetable places adoption of the principal List of Questions around Day 120 in the standard procedure, after the initial assessment phase. The exact timetable can vary according to the application and current procedural arrangements. citeturn0search3turn0search19

16. The First Clock Stop

When CHMP sends questions to the applicant, the assessment clock stops while the applicant prepares its response, in accordance with the applicable procedure.

This mechanism is essential to understanding the frequently quoted 210-day assessment period. The 210 days are active assessment time; they do not necessarily represent 210 consecutive calendar days from submission to CHMP opinion. citeturn0search0turn0search19

The duration of the clock stop is governed by the applicable procedural arrangements and the time agreed for the applicant's response. Applicants must therefore manage responses as formal regulatory deliverables rather than treating the clock stop as an unrestricted period for internal discussion.

A strong response should address each question explicitly, identify the supporting evidence and make clear whether any proposed change to the dossier or product information follows from the response.

17. Assessment of the Applicant's Responses

When the clock restarts, the assessment teams examine the applicant's responses and determine whether the issues have been resolved.

Three broad outcomes are possible:

  1. the response adequately resolves the issue;
  2. the response resolves part of the issue but leaves a residual concern; or
  3. the response does not resolve the concern.

The third outcome does not necessarily end the procedure. Scientific assessment is iterative, and remaining issues may be incorporated into later questions or the List of Outstanding Issues (LoOI).

The important regulatory principle is that the applicant does not obtain a positive conclusion merely by submitting a response. The committee assesses whether the response actually resolves the underlying scientific concern.

18. List of Outstanding Issues

Later in the assessment, CHMP may identify issues that remain unresolved after the applicant's responses to the initial questions.

These are consolidated into a List of Outstanding Issues where applicable.

The LoOI is qualitatively different from the initial LoQ. The initial questions explore the application and seek clarification or additional information. Outstanding issues represent matters that remain material to the committee's final assessment.

This distinction is useful when reconstructing a regulatory history. A question in the initial assessment does not necessarily represent a fundamental objection. An issue that remains outstanding later in the procedure has greater regulatory significance because it has survived the earlier exchange between the applicant and assessors.

19. Second Clock Stop and Further Discussion

Where significant outstanding issues remain, the procedure may enter a further clock stop while the applicant prepares additional responses.

EMA's published description of the standard evaluation process identifies a second clock stop around the later assessment stage and notes that an oral explanation may be organised where appropriate. citeturn0search3

The purpose is not to create an additional opportunity for negotiation detached from the scientific evidence. It provides the applicant with a formal opportunity to address the committee's remaining concerns before CHMP reaches its final scientific conclusion.

The applicant's response should therefore concentrate on the actual outstanding issues rather than simply restating the original dossier position.

20. Oral Explanation

In appropriate circumstances, the applicant may be invited to provide an oral explanation to CHMP.

An oral explanation is a formal part of the regulatory procedure, not a commercial presentation. Its purpose is to allow the applicant to address unresolved scientific or regulatory issues directly before the committee.

EMA's published evaluation process notes that an oral explanation may be requested by the applicant or CHMP and is usually organised when major objections or outstanding issues remain. citeturn0search3

The existence of an oral explanation should not itself be interpreted as proof that the application will receive a negative opinion. Its significance is that the committee has identified matters requiring further clarification before concluding its assessment.

The applicant's representatives must therefore be able to explain the evidence, the interpretation of the evidence and the proposed regulatory response precisely. Unsupported advocacy is not a substitute for resolving a scientific concern.

21. Additional Scientific Consultation

The assessment may require expertise beyond the routine assessment teams.

EMA describes circumstances in which rapporteurs or CHMP members may propose consultation with a scientific advisory group, ad-hoc expert group or other specialist expertise. Patients and healthcare professionals may also contribute through appropriate consultation mechanisms. citeturn0search3

Such consultation does not transfer the legal responsibility for the CHMP opinion to the external experts. Rather, it provides additional scientific or clinical expertise to inform the committee's assessment.

This distinction matters when interpreting consultation reports: expert advice contributes to the evidence considered by the committee but is not itself the final marketing-authorisation decision.

22. Pharmacovigilance and Risk Management During the Assessment

Safety assessment is integrated into the centralised procedure.

EMA states that CHMP evaluates centralised marketing-authorisation applications with input from PRAC on aspects of the risk-management plan and, for advanced therapy medicines, input from CAT within its remit. citeturn0search1

For a QPPV or pharmacovigilance professional, this is an important point. The pharmacovigilance system is not merely an operational requirement that starts after authorisation. The proposed system, risk-management measures and important uncertainties form part of the regulatory assessment of whether the medicine can be authorised under the proposed conditions.

The assessment may therefore consider:

The precise requirements depend on the product and application. The general principle is that safety obligations are connected to the benefit-risk assessment rather than being an independent administrative layer.

23. How Safety Evidence Can Change the Application

A safety issue identified during assessment can affect more than the safety section of the dossier.

For example, a new analysis may lead to:

The regulatory response must follow the evidence and the applicable legal framework. It is not appropriate to assume that every safety concern requires a label change, just as it is inappropriate to assume that a risk can be managed solely through pharmacovigilance activity without considering the authorised conditions of use.

This is where the scientific assessment becomes an integrated regulatory assessment rather than a collection of separate discipline reports.

24. Quality, Efficacy and Safety Are Assessed Together

The centralised procedure ultimately asks whether the medicinal product can be authorised with a favourable benefit-risk balance under defined conditions of use.

Quality, efficacy and safety are therefore not three independent approval tests whose conclusions are simply added together.

A quality issue can affect clinical performance or safety. A clinical efficacy uncertainty can alter the significance of a safety concern. A safety finding can change the acceptable indication or target population. Risk-minimisation measures can alter the conditions under which the benefit-risk balance is considered.

The scientific assessment therefore needs an integrated conclusion.

This is one reason why the final CHMP opinion should be read as the committee's overall regulatory conclusion rather than as a simple summary of separate quality, non-clinical and clinical reports.

25. Accelerated Assessment

The standard centralised assessment can, in defined circumstances, be shortened through accelerated assessment.

Under the current EMA guidance, CHMP may reduce the assessment timeframe from up to 210 active days to 150 active days where the medicinal product is considered to be of major interest from the point of view of public health and the applicant provides the required justification. The evidence requirements remain the same as for other applications. citeturn0search0turn0search4

Accelerated assessment should therefore not be understood as a lower evidentiary standard or a faster route because the applicant wants an earlier decision.

The purpose is to make the regulatory assessment more rapid for medicines of major public-health interest where the legal and scientific criteria for accelerated assessment are met.

The request should be made sufficiently early to allow the Agency and committees to consider it before the application enters the standard assessment process. Current EMA guidance advises applicants to request accelerated assessment at least two to three months before submission. citeturn0search4

26. The Applicant's Role During Assessment

The applicant remains actively involved throughout the procedure.

Its responsibilities include responding to questions within agreed timelines, providing accurate and complete information, maintaining consistency across the dossier and product information, and ensuring that new information relevant to the assessment is communicated through the appropriate regulatory channels.

For a large application, this requires substantial internal coordination between regulatory affairs, clinical development, statistics, safety, quality, medical writing, manufacturing and other functions.

From a regulatory perspective, the applicant should maintain a single controlled understanding of:

A response that solves one question while creating inconsistencies elsewhere in the application can create additional regulatory problems.

27. The Role of EMA's Product Team

EMA establishes a product team for centrally authorised medicinal products to support the scientific committees and the assessment process.

The current pre-authorisation guidance describes the product team's role as including procedural support, liaison with rapporteurs, regulatory and procedural advice, technical support for preparation and validation of the application, and support for the preparation of assessment documents and questions. citeturn0search0

This is an important operational distinction. EMA's product team facilitates the regulatory process; it does not replace the scientific judgment of the committees.

The product team can therefore be viewed as part of the procedural infrastructure that allows the scientific assessment to function effectively.

28. The Assessment Is Not a Negotiation of the Scientific Standard

The iterative nature of the procedure can sometimes create the impression that the applicant and committee are negotiating the terms of approval.

That is not the correct regulatory model.

The applicant can clarify evidence, provide additional analyses and propose changes. The assessors and committees can identify uncertainties and request information. But the scientific standard remains governed by the applicable legislation, scientific principles and regulatory guidance.

The objective of the interaction is to enable the committee to reach a scientifically justified conclusion on the evidence available to it.

A regulatory response is therefore strongest when it addresses the scientific problem directly rather than attempting to reframe an unresolved issue as a matter of presentation.

29. Moving Toward the CHMP Opinion

As the assessment progresses, the committee moves from identifying and resolving individual issues toward an integrated conclusion.

The final questions are essentially:

  1. Is the quality of the medicinal product adequately established and controlled?
  2. Is the evidence of efficacy sufficient for the proposed indication and population?
  3. Are the identified risks adequately characterised and manageable?
  4. Are important uncertainties appropriately addressed?
  5. Are the proposed risk-management and pharmacovigilance measures adequate?
  6. Is the proposed product information consistent with the scientific evidence?
  7. Taking the totality of evidence into account, is the benefit-risk balance favourable under the proposed conditions of use?

These questions are not a rigid checklist applicable identically to every medicine. They are a useful conceptual model for understanding how the multidisciplinary evidence is brought together.

30. The CHMP Opinion

At the conclusion of the scientific assessment, CHMP adopts its scientific opinion on whether the medicinal product should be authorised.

The opinion represents the formal scientific conclusion of the committee. It is based on the assessment of the application and the information generated during the procedure.

A positive opinion supports the subsequent Union authorisation process. A negative opinion means that the scientific committee has concluded that the applicable conditions for authorisation have not been met on the evidence available at that point in the procedure.

The distinction between the CHMP opinion and the subsequent European Commission decision is fundamental and is treated in greater depth in Article 28 of this series.

31. What Happens After the CHMP Opinion?

The centralised procedure does not end when CHMP adopts its opinion.

For a positive opinion, the opinion is transmitted to the European Commission, which proceeds with the Union decision-making process. The Commission decision establishes the legally operative centralised marketing authorisation.

The exact legal effect and procedural relationship between the CHMP opinion and Commission decision should therefore be determined from the applicable legislation and the final decision itself.

For a negative opinion, the applicable procedural framework provides for the applicant's rights, including re-examination under the relevant conditions.

The next article in this curriculum, CHMP Scientific Opinions and European Commission Marketing Authorisation Decisions, examines this transition in detail.

32. From Initial Authorisation to Lifecycle Regulation

Once the European Commission grants the centralised marketing authorisation, the product enters a different phase of regulatory activity.

The authorisation establishes the legal conditions under which the product may be marketed, but it does not freeze the product's regulatory state permanently.

New evidence, manufacturing changes, safety findings, new indications and other developments can require regulatory action.

The appropriate mechanism may be a variation, extension, renewal where applicable, pharmacovigilance procedure, referral or another post-authorisation procedure.

This is why the centralised procedure should be understood as the entry point into a regulated lifecycle, not as the conclusion of regulatory oversight.

Article 29, How an EU Marketing Authorisation Is Maintained After Approval, will address that lifecycle at a higher level before Part IV examines individual post-authorisation mechanisms in detail.

Practical regulatory perspective

When reviewing a live centralised application, it is useful to keep four layers separate:

Layer Question
Evidence What information is available?
Scientific assessment What does the evidence establish and what remains uncertain?
Regulatory conclusion Does the evidence support the proposed conditions of use and benefit-risk balance?
Legal act What decision gives the conclusion its legal effect?

Confusing these layers is a common source of errors when reading regulatory documents.

An assessment report is not the same thing as a CHMP opinion. A CHMP opinion is not the same thing as the European Commission decision. A public summary is not necessarily the legally operative document.

For regulatory professionals, maintaining these distinctions is more useful than memorising a simplified organisational chart.

Key Takeaways

Regulatory Note

The standard centralised procedure described here is a teaching model based on the current EU legal and procedural framework. Individual applications can involve product-specific requirements, accelerated assessment, conditional marketing authorisation, exceptional circumstances, additional committee involvement, inspections, scientific consultations or other procedural features.

The current EMA pre-authorisation guidance was updated in August 2026 and should be checked for live procedural requirements. The standard 210-day framework refers to active assessment time and excludes applicable clock stops. It should not be interpreted as a guarantee of a fixed elapsed calendar period from submission to authorisation. citeturn0search0turn0search19

For a live regulatory matter, the applicable consolidated legislation, current EMA procedural guidance, procedure-specific timetable and formal regulatory documents take precedence over this educational explanation.

References

  1. European Parliament and Council. Regulation (EC) No 726/2004, as amended. Principal legal basis for the Union centralised procedure, CHMP scientific responsibilities and the European Commission's centralised marketing-authorisation decision.
  2. European Parliament and Council. Directive 2001/83/EC, as amended. Core EU legislation governing medicinal products for human use and the wider pharmaceutical regulatory framework.
  3. European Medicines Agency. Pre-authorisation guidance for users of the centralised procedure. Current procedural guidance covering eligibility, pre-submission activities, rapporteur appointment, submission, validation and assessment. The current version was updated in August 2026. citeturn0search0
  4. European Medicines Agency. Obtaining an EU marketing authorisation — step-by-step. Current overview of the centralised procedure and the roles of CHMP, PRAC and CAT. citeturn0search1
  5. European Medicines Agency. The evaluation of medicines, step-by-step. Public explanation of the standard assessment sequence, questions, clock stops, outstanding issues and oral explanations. citeturn0search3
  6. European Medicines Agency. Accelerated assessment. Current guidance on the 150-day accelerated assessment route and its eligibility requirements. citeturn0search4
  7. European Medicines Agency. Time allowed for applicants to respond to questions and issues raised during assessment of new marketing-authorisation applications in the centralised procedure. Procedural guidance concerning applicant response periods during the assessment. citeturn0search5

Key Takeaways

References

  1. European Parliament and Council. Regulation (EC) No 726/2004, as amended. Primary legal basis for the centralised procedure, the European Medicines Agency and Union authorisation and supervision of medicinal products.
  2. European Parliament and Council. Directive 2001/83/EC, as amended. Relevant Union pharmaceutical legislation governing medicinal products for human use and interacting with the centralised framework.
  3. European Medicines Agency. Pre-authorisation guidance for users of the centralised procedure. Current procedural guidance covering eligibility, pre-submission activities, appointment of rapporteurs, submission, validation and assessment.
  4. European Medicines Agency. Obtaining an EU marketing authorisation — step-by-step. Current public overview of the centralised marketing-authorisation process.
  5. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Current information on CHMP's scientific role in the centralised procedure.
  6. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC). Current information on PRAC's role in pharmacovigilance and risk-management assessment.
  7. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module V — Risk Management Systems. Current guidance concerning risk-management plans and risk-minimisation measures relevant to marketing-authorisation applications.
  8. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module I — Pharmacovigilance systems and their quality systems. Current guidance relevant to pharmacovigilance governance and quality requirements.
  9. European Commission. Notice to Applicants and current pharmaceutical legislation. Current regulatory requirements and procedural information should be consulted for live applications.
  10. European Medicines Agency. Committee for Medicinal Products for Human Use: Rules of Procedure and applicable procedural guidance. Current committee procedures should be consulted where detailed procedural questions arise.

Regulatory Note

This article is an educational explanation of the EU centralised marketing-authorisation procedure. It is not legal advice and does not replace Regulation (EC) No 726/2004, Directive 2001/83/EC, current EMA procedural guidance, applicable Commission rules, GVP or the procedure-specific documents for an individual application.

The exact eligibility requirements, submission arrangements, procedural timetable, assessment steps, committee involvement and decision-making process depend on the current legislation and the characteristics of the application. Regulatory procedures and guidance are amended periodically; current primary sources should therefore be checked for live regulatory work.

The article deliberately distinguishes scientific assessment from legal decision-making. EMA, its scientific committees, rapporteurs, national competent authorities and the European Commission have different functions within the centralised system. A rapporteur assessment, CHMP opinion and European Commission decision should not be treated as interchangeable documents.

The 210-day standard assessment framework and accelerated-assessment framework described in this article are procedural concepts based on the applicable Union framework and current EMA guidance. They should not be interpreted as guaranteed calendar durations for an individual application. Clock stops, procedural circumstances and application-specific arrangements affect the overall timeline.

Where this article cross-refers to CHMP Scientific Opinions and European Commission Marketing Authorisation Decisions and How an EU Marketing Authorisation Is Maintained After Approval, those articles provide the dedicated treatment of those subjects rather than repeating their full detail here.

For a live application, the current consolidated legislation, EMA procedural guidance, formal communications, adopted scientific documents and legally operative European Commission decision take precedence over this general educational explanation.

Revision History

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Last reviewed: 2026-08-24