EMA, European Commission, National Competent Authorities, CHMP, PRAC and CMDh: Who Does What?

1. Why Institutional Roles Are Easy to Confuse

The European medicines regulatory system is a network rather than a single regulator.

European Union legislation assigns different responsibilities to the European Commission, the European Medicines Agency (EMA), national competent authorities and scientific committees. Their functions overlap operationally because they work together, but their legal mandates are different.

That distinction matters.

A scientific committee can assess evidence without being the body that grants a marketing authorisation. EMA can coordinate a procedure without itself being the legal decision-maker. A national competent authority can participate in a Union assessment while retaining national regulatory responsibilities. The European Commission can adopt a legally binding decision without performing the scientific assessment itself.

A reliable way to read the system is therefore to separate four functions:

1. law and legal decision-making;
2. scientific assessment;
3. regulatory coordination and infrastructure;
4. national implementation and supervision.

The institutions discussed in this chapter occupy different positions within those functions.

2. The European Medicines Regulatory Network

The European medicines regulatory system combines Union institutions with the competent authorities of the Member States.

EMA provides the central scientific and coordination infrastructure for matters within its mandate. National competent authorities provide national regulatory expertise and carry out many activities directly within Member States. Scientific committees bring together experts from across the network.

This structure allows regulatory decisions to draw on expertise distributed across Europe rather than requiring one institution to contain all scientific and operational capacity.

A simplified model is:

                 EU legislation
                      │
        ┌─────────────┴─────────────┐
        │                           │
European Commission          Member States
        │                           │
Legal decisions              National competent
where provided                authorities
        │                           │
        └─────────────┬─────────────┘
                      │
                    EMA
                      │
        Scientific committees and
        regulatory coordination
          ┌───────────┴───────────┐
         CHMP                     PRAC
          │                        │
          └───────────┬────────────┘
                      │
                     CMDh
            within its specific
          national-authorisation role

This is a conceptual map, not an organisational chart. The actual relationship depends on the legal procedure.

3. The European Commission

The European Commission is an institution of the European Union and has important responsibilities under EU medicines legislation.

For centrally authorised human medicines, the Commission adopts the legally operative Union marketing-authorisation decision following the applicable scientific assessment.

Its medicines-related responsibilities extend beyond individual marketing authorisations. The Commission is also involved in the development and implementation of the Union pharmaceutical framework and in legally defined regulatory measures.

The Commission should therefore be distinguished from EMA.

EMA provides scientific and regulatory infrastructure within its legal mandate. The Commission has the Union-level legal and policy responsibilities assigned to it by EU law.

4. EMA

The European Medicines Agency is the Union agency responsible for coordinating the existing scientific expertise of national competent authorities for the evaluation and supervision of medicines within its mandate.

EMA supports scientific committees, coordinates regulatory procedures, provides scientific and regulatory information, and maintains infrastructure for the European medicines regulatory network.

EMA is therefore not simply a centralised medicines authority replacing national regulators.

Its role is better understood as a Union-level scientific and coordination institution operating through a European regulatory network.

This distinction explains why national experts and national competent authorities remain deeply involved in procedures coordinated by EMA.

5. EMA Does Not “Approve” Every Medicine

The phrase “EMA approved the medicine” is common in public communication but can be legally imprecise.

For a centralised marketing authorisation, the scientific assessment is conducted through the EMA system and CHMP adopts a scientific opinion. The European Commission subsequently adopts the legally operative marketing-authorisation decision.

For medicines authorised nationally, through MRP or through DCP, the legal authorisation structure is different.

The correct description therefore depends on the procedure.

A regulatory professional should identify the scientific body, the legal decision-maker and the authorisation route before describing an “approval.”

6. National Competent Authorities

National competent authorities (NCAs) are the medicines regulatory authorities of the Member States.

They have substantial responsibilities under both national and Union medicines law.

Depending on the Member State and regulatory activity, these can include:

• assessment of nationally authorised medicines;
• inspections;
• pharmacovigilance;
• enforcement;
• regulatory implementation;
• participation in EU procedures;
• provision of scientific experts to European committees.

NCAs are therefore not merely local administrative offices beneath EMA.

They are essential components of the European regulatory network.

7. Why National Authorities Remain Essential

The EU medicines system is deliberately distributed.

National authorities possess scientific expertise, inspection capacity, knowledge of national healthcare systems and direct regulatory responsibilities that cannot simply be transferred to an EU agency.

National experts can participate in scientific committees and assessment teams while their authorities continue to exercise national functions.

The result is a network in which Union-level assessment and national regulatory activity are closely connected.

8. The Committee for Medicinal Products for Human Use

The Committee for Medicinal Products for Human Use (CHMP) is the EMA scientific committee responsible for medicinal products for human use within its legal mandate.

CHMP's responsibilities include scientific assessment of centralised marketing-authorisation applications and specified post-authorisation and referral procedures.

CHMP is composed of scientific experts nominated through the Member States and appointed under the applicable legal framework.

The committee's role is scientific and regulatory rather than equivalent to that of the European Commission as a legal decision-maker.

9. What CHMP Actually Does

CHMP evaluates scientific evidence and reaches conclusions within the procedures assigned to it.

Depending on the procedure, its work can concern:

• quality;
• safety;
• efficacy;
• benefit-risk balance;
• changes to authorised conditions;
• referral questions;
• other regulatory matters within its mandate.

Its conclusions are expressed through the appropriate scientific regulatory output, such as an opinion.

The precise legal consequences depend on the procedure under which CHMP is acting.

10. CHMP Is Not a Generic “EU Approval Committee”

CHMP should not be treated as the body that makes every medicines decision in Europe.

Its mandate is defined by EU law.

It has a central role in the centralised procedure and in specified Union procedures, but nationally authorised medicines can involve national competent authorities and CMDh, and pharmacovigilance questions can involve PRAC.

The committee's identity therefore tells you something about the scientific procedure, but it does not by itself tell you the legal status of the final outcome.

11. The Pharmacovigilance Risk Assessment Committee

The Pharmacovigilance Risk Assessment Committee (PRAC) is the EMA committee responsible for assessing and monitoring safety issues for human medicines.

PRAC has a specialist pharmacovigilance mandate.

Its work includes:

• assessment of safety signals;
• pharmacovigilance systems and processes within its mandate;
• risk-management questions;
• safety-related recommendations and regulatory procedures.

PRAC is consequently a central scientific body for EU pharmacovigilance.

Its role should not, however, be interpreted as replacing CHMP or national competent authorities.

12. PRAC and the Benefit-Risk Balance

PRAC's work is fundamentally connected with the continuing assessment of whether the benefits and risks of a medicine remain acceptable under its authorised conditions.

A safety signal does not automatically establish a causal relationship or require a change to the marketing authorisation.

PRAC may consider the totality of the evidence, including clinical, epidemiological, pharmacovigilance and other relevant information.

Depending on the legal procedure, PRAC may recommend regulatory action or conclude that existing measures remain appropriate.

The precise effect of a PRAC recommendation depends on the procedure and subsequent regulatory steps.

13. PRAC Does Not Grant Marketing Authorisations

PRAC is a pharmacovigilance scientific committee.

It is not the body that grants a centralised marketing authorisation.

For a centrally authorised medicine, a PRAC safety recommendation can feed into a subsequent CHMP process where required by the applicable legal framework, followed where appropriate by a European Commission decision.

For nationally authorised medicines, the applicable procedure can involve CMDh and national competent authorities.

The path depends on the legal basis of the regulatory action.

14. The Coordination Group for Mutual Recognition and Decentralised Procedures – Human

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) operates within the regulatory framework for nationally authorised human medicines.

Its role is closely connected with MRP and DCP procedures and with specified disagreements or regulatory questions involving nationally authorised medicines.

CMDh is therefore fundamentally different from CHMP and PRAC in both its legal context and its regulatory function.

It should be understood as a coordination body within the Member-State authorisation network.

15. What CMDh Does

CMDh facilitates coordination between Member States in relation to nationally authorised medicines.

Its work can include:

• issues arising from MRP and DCP;
• coordination between Member States;
• specified disagreements concerning nationally authorised medicines;
• implementation and harmonisation matters within its legal mandate.

Where a disagreement cannot be resolved through the CMDh framework and the statutory conditions for a Union referral are met, the matter may move to the relevant Union procedure.

16. CHMP, PRAC and CMDh Are Not Interchangeable

The differences can be summarised as follows:

The table is deliberately simplified.

A particular procedure can involve more than one body, and the legal effect of an output depends on the applicable legislation.

17. Scientific Assessment Versus Legal Decision

This is the most important distinction in understanding the EU regulatory network.

Scientific bodies assess evidence and reach conclusions within their mandates.

Legal decision-makers adopt the acts that have the legal effect assigned to them by EU law.

For the centralised marketing-authorisation procedure, the basic relationship is:

Application
    ↓
Scientific assessment
    ↓
CHMP opinion
    ↓
European Commission decision
    ↓
Marketing authorisation

This structure prevents a common error: treating the scientific opinion and the legally operative decision as the same document or the same institutional act.

18. Recommendation, Opinion and Decision Are Different Concepts

Regulatory documents often use words such as recommendation, opinion, position and decision.

They should not be treated as interchangeable.

The legal effect of an output depends on the body issuing it, the legal basis of the procedure and the applicable legislation.

For example, a PRAC recommendation is not equivalent to a European Commission decision. A CHMP opinion is not automatically identical to the final legal act that follows it.

The terminology should therefore be read in its legal context.

19. Who Supplies the Scientific Expertise?

The European system relies heavily on experts from the Member States.

Scientific expertise can include specialists in:

• clinical medicine;
• pharmacology;
• toxicology;
• epidemiology;
• biostatistics;
• pharmaceutical quality;
• pharmacovigilance;
• other relevant disciplines.

These experts contribute to assessments and committee work under the structures established by EU law.

The distributed expert model is one of the defining strengths of the European regulatory network.

20. The Relationship Between EMA and Its Committees

EMA provides the organisational and regulatory infrastructure through which its scientific committees operate.

The committees are not independent agencies separate from EMA.

At the same time, a committee's scientific mandate should not be confused with EMA's broader organisational functions.

A useful distinction is:

• EMA: agency, infrastructure and coordination;
• CHMP: scientific committee for human medicines within its mandate;
• PRAC: pharmacovigilance scientific committee;
• CMDh: Member-State coordination body for nationally authorised human medicines.

This distinction makes regulatory documents easier to interpret.

21. How the Institutions Work Together in a Centralised Application

A centralised application illustrates the division of responsibilities particularly clearly.

The applicant submits through the centralised regulatory framework. EMA coordinates the scientific assessment. CHMP evaluates the application and adopts the relevant scientific opinion. The European Commission then follows the legal decision-making procedure applicable to the centralised authorisation.

The national authorities have not disappeared from the process. Their experts contribute to the European network and to scientific assessment activities.

The procedure is therefore neither purely “EMA” nor purely “Commission”. It is a network procedure with distinct institutional roles.

22. The Basic Centralised Architecture

The relationship can be represented as:

Applicant
   │
   ▼
EMA regulatory framework
   │
   ▼
Scientific assessment
   │
   ▼
CHMP opinion
   │
   ▼
European Commission
   │
   ▼
Union marketing-authorisation decision

The model is intentionally simplified. Specific procedures can involve additional committees, procedural stages and interactions with national authorities.

Its purpose is to make one point clear: scientific assessment and legal authorisation are separate functions.

23. How National Authorities Contribute to Centralised Procedures

National competent authorities provide much of the scientific expertise used by the European regulatory network.

Experts from Member States can participate in assessment teams and scientific committees.

This means that a centralised assessment should not be imagined as scientists working exclusively inside an EMA building.

EMA coordinates the network; national experts contribute expertise under the established regulatory arrangements.

The centralised procedure is consequently a European network activity even though its legal authorisation is Union-level.

24. The Rapporteur Model

Scientific assessment is commonly organised through designated experts, including rapporteurs and, where applicable, co-rapporteurs.

The rapporteurs lead important parts of the scientific assessment and prepare assessment work for consideration by the relevant committee.

They do not independently grant or refuse a marketing authorisation.

Their scientific work contributes to the committee's collective assessment.

This distinction is useful when reading European Public Assessment Reports and other regulatory documents: an individual assessor's conclusion is not necessarily the final committee position.

25. Committee Decisions Are Collective Regulatory Outputs

Scientific committees operate through collective consideration of the evidence.

An assessment report may contain detailed scientific reasoning developed by assessment teams and rapporteurs. The committee subsequently considers the evidence and the regulatory questions before adopting its formal output.

The distinction between an assessment document and the final committee opinion is important.

A detailed assessment report can explain how the evidence was evaluated, while the committee opinion represents the committee's formal conclusion under the relevant procedure.

26. What Happens When a Safety Issue Emerges?

A safety issue can enter the European regulatory system through several routes.

For example, new information may arise through spontaneous reports, epidemiological studies, clinical data, literature, post-authorisation studies or other sources.

The presence of a safety signal does not itself determine which institution will make the final regulatory decision.

The legal status of the medicine, the type of procedure and the statutory mechanism determine which bodies become involved.

For pharmacovigilance matters, PRAC has a central role in the scientific safety assessment.

27. A Typical Pharmacovigilance Pathway

A simplified model is:

New safety information
        ↓
Signal / safety concern
        ↓
Pharmacovigilance assessment
        ↓
PRAC where applicable
        ↓
Recommendation / regulatory output
        ↓
Relevant subsequent procedure
        ↓
CHMP / CMDh / national authorities
        ↓
Commission decision where legally required

Not every safety issue follows every step in this diagram.

The diagram illustrates why it is unsafe to assume that a PRAC recommendation is always the final regulatory act.

28. PRAC and Centrally Authorised Medicines

For centrally authorised medicines, PRAC can assess pharmacovigilance issues within its mandate and adopt the applicable recommendation or other scientific output.

Where a formal regulatory change requires a subsequent CHMP opinion and Commission decision, those stages follow according to the relevant legal procedure.

The exact sequence depends on the legal basis and the nature of the regulatory action.

The institutional chain should therefore be reconstructed from the procedure rather than inferred from the committee's name.

29. PRAC and Nationally Authorised Medicines

Nationally authorised medicines can also be subject to EU pharmacovigilance procedures.

In such circumstances, PRAC may have a central scientific role even though the underlying marketing authorisations are national.

The subsequent regulatory implementation can involve CMDh and national competent authorities, depending on the legal procedure.

This is one of the clearest examples of why “nationally authorised” does not mean “outside the EU regulatory system”.

30. Referral Procedures as Institutional Bridges

Referral procedures are designed to bring specified regulatory questions into a coordinated Union framework.

They can therefore connect institutions that normally perform different functions.

For example, a safety concern involving nationally authorised medicines may involve PRAC and subsequently CMDh or another Union mechanism. A non-pharmacovigilance Article 31 referral can involve CHMP directly. An Article 29(4) procedure can arise from disagreement during MRP or DCP.

The legal basis determines the institutional pathway.

31. Article 20 Pharmacovigilance Procedures

Article 20 of Regulation (EC) No 726/2004 provides a specific pharmacovigilance framework for centrally authorised medicines.

The procedure involves PRAC and, where the legal framework requires, CHMP and the European Commission.

The key point is institutional sequencing: PRAC performs the pharmacovigilance scientific assessment within its mandate; subsequent legal steps depend on the applicable procedure.

This is different from an Article 31 non-pharmacovigilance referral, where the scientific question falls outside the pharmacovigilance pathway.

32. Article 31 Referrals

Article 31 of Directive 2001/83/EC covers specified Union referral procedures for medicinal products, with separate pathways depending on whether the matter arises from pharmacovigilance data or other data.

The pharmacovigilance pathway can involve PRAC before subsequent regulatory steps.

A non-pharmacovigilance Article 31 procedure is assessed through the CHMP framework.

The distinction is important because the same broad term, “Article 31 referral”, can refer to different scientific and procedural pathways.

33. Article 107i Urgent Union Procedures

Article 107i of Directive 2001/83/EC provides an urgent Union procedure for pharmacovigilance matters meeting the statutory conditions.

It is designed for situations requiring rapid Union-level assessment of a safety issue.

PRAC has a central role in the scientific assessment.

The urgency of the procedure does not eliminate the need to distinguish scientific recommendations from the subsequent legal implementation.

34. Article 30 Referrals

Article 30 of Directive 2001/83/EC provides a mechanism for addressing divergence between national marketing authorisations where the interests of the Union are involved and the statutory conditions are met.

The procedure can result in a CHMP scientific opinion and subsequent regulatory action.

It is therefore another example in which CHMP involvement should not be interpreted as meaning that the product was originally centrally authorised.

The legal basis and procedural history determine the meaning of the CHMP involvement.

35. CMDh in an MRP/DCP Disagreement

When disagreement arises during an MRP or DCP, CMDh provides the relevant coordination framework within its mandate.

The group seeks resolution between the participating Member States.

Where the statutory conditions for escalation are met and agreement cannot be reached, the matter can move into the applicable Union referral procedure.

This illustrates the network's layered design:

National procedure
       ↓
Member-State coordination
       ↓
CMDh
       ↓
Union referral where legally required
       ↓
Relevant scientific committee
       ↓
Legal decision / national implementation

The exact route depends on the legal basis.

36. Who Makes the Final Decision?

The answer cannot be given without identifying the procedure.

For a centralised marketing authorisation, the European Commission adopts the legally operative Union decision.

For a national marketing authorisation, the relevant national competent authority acts under the applicable national and EU framework.

For MRP and DCP, national authorisations are established through the Member-State regulatory framework following the coordinated procedure.

For referral procedures, the final legal effect depends on the relevant legislation and the type of referral.

The first question should therefore always be: What is the legal procedure?

37. Who Supervises the Medicine After Authorisation?

Post-authorisation supervision is distributed across the network.

National competent authorities retain important responsibilities, including national pharmacovigilance and inspection functions.

EMA and its committees have Union-level responsibilities within their mandates.

The European Commission exercises the legal powers assigned to it under Union medicines legislation.

Post-authorisation supervision is consequently a continuing network activity rather than the responsibility of one institution alone.

38. Inspections and Compliance

Inspection activity is an important area in which national authorities remain highly visible.

Manufacturing, distribution and other regulated activities are subject to inspection and oversight under the applicable legal framework.

The European regulatory system coordinates certain aspects of inspection and relies on national competent authorities and their inspectorates.

An EMA committee should therefore not be assumed to be the operational inspection authority for every regulated site.

39. Pharmacovigilance System Oversight

Pharmacovigilance responsibilities similarly operate through a network.

MAHs maintain pharmacovigilance systems and have defined obligations under EU law. National competent authorities and EMA participate in pharmacovigilance oversight according to their respective mandates, while PRAC provides specialist scientific assessment at Union level.

This division means that an MAH may interact with several regulatory bodies during the lifecycle of one medicine.

The relevant authority depends on the activity and legal procedure.

40. Regulatory Implementation Is Not the Same as Scientific Assessment

A scientific committee can conclude that a regulatory change is warranted.

Implementation then requires the legally appropriate regulatory act and operational steps.

Those steps can include changes to product information, updates to risk-management documentation, variations, communications, national implementation measures or other actions required by the specific decision.

The scientific conclusion and the operational implementation should therefore be tracked as separate events in a regulatory timeline.

41. Reading an EMA Regulatory Document Correctly

When opening an EMA document, identify at least five things:

1. What procedure is this?
2. Which legal basis applies?
3. Which body issued the document?
4. Is it an assessment, recommendation, opinion or decision?
5. What legal or operational step follows it?

This simple method prevents many errors in regulatory interpretation.

A document's title alone is rarely sufficient.

42. A Regulatory Responsibility Matrix

This matrix is a teaching aid rather than a complete statement of every statutory responsibility.

43. Why Institutional Precision Matters for an MAH

For a marketing-authorisation holder, confusing institutions can produce practical errors.

Examples include:

• addressing a submission to the wrong authority;
• misunderstanding whether a scientific recommendation is legally operative;
• failing to identify a national implementation step;
• assuming an EMA publication is itself a marketing-authorisation decision;
• misunderstanding which committee owns a scientific question.

Regulatory strategy therefore begins with institutional and legal mapping.

44. A Practical Method for Regulatory Mapping

For any regulatory event, document the following:

Product status — centrally or nationally authorised.

Procedure — initial authorisation, variation, referral, safety procedure, MRP/DCP issue or another mechanism.

Legal basis — the applicable EU legislation and article.

Scientific body — CHMP, PRAC, CMDh or another competent body.

Legal decision-maker — Commission, national authority or other body specified by law.

Implementation — what must actually change in the product's regulatory status or documentation.

This produces a defensible regulatory record.

45. The Institutional Chain Is Procedure-Specific

There is no universal sequence such as:

EMA → CHMP → PRAC → Commission.

That sequence is wrong because the committees do not form a simple hierarchy.

A more accurate principle is:

The legal procedure determines which institutions participate and in what order.

The same medicine can interact with different bodies at different points in its lifecycle.

46. A Worked Example: New Centralised Application

Suppose a company submits an application for a medicinal product that falls within the centralised procedure.

The application enters the centralised regulatory framework. EMA coordinates the assessment. Rapporteurs and assessment teams evaluate the evidence. CHMP considers the scientific assessment and adopts its opinion.

The European Commission then follows the applicable decision-making process and adopts the Union marketing-authorisation decision if the legal requirements are satisfied.

After authorisation, the product remains subject to continuing regulatory and pharmacovigilance obligations.

This example demonstrates why describing the entire process as “EMA approval” loses important information.

47. A Worked Example: Safety Issue With a Nationally Authorised Medicine

Suppose important new safety information emerges for a medicine authorised nationally in several Member States.

The issue may enter an EU pharmacovigilance procedure if the legal conditions are met.

PRAC may assess the safety issue at Union level. Depending on the legal pathway and outcome, subsequent steps can involve CMDh, national competent authorities, CHMP or the European Commission.

The exact route must be established from the procedure's legal basis.

The example illustrates the central principle: the authorisation route and the route of a later safety procedure are related but not identical concepts.

48. Worked Example: MRP Disagreement

Suppose a product is undergoing an MRP and one participating Member State raises a substantive concern that cannot be resolved within the procedure.

The matter enters the applicable coordination and dispute-resolution framework.

CMDh may become involved according to its mandate. If the statutory conditions for a Union referral are met and the disagreement remains unresolved, the matter can proceed to the relevant Union scientific procedure.

The eventual regulatory outcome must then be implemented according to the applicable legal framework.

Again, the institutional pathway follows the legal procedure.

49. The Best Mental Model

The most useful way to understand the EU medicines network is not as a ladder of organisations.

It is a network of legally defined functions.

                         EU law
                           │
          ┌────────────────┼────────────────┐
          │                │                │
     Commission          EMA              Member States
          │                │                │
   Legal decisions   Scientific /       NCAs and
                     coordination       national systems
                           │
              ┌────────────┴────────────┐
              │                         │
             CHMP                      PRAC
              │                         │
              └────────────┬────────────┘
                           │
                         CMDh
                   where national-
                  authorisation law
                     requires it

The diagram should not be read as showing that CMDh reports to PRAC or CHMP. It does not. The boxes represent functional relationships, not a management hierarchy.

50. The Core Lessons

Six principles are sufficient to prevent most basic institutional errors.

1. EMA is an EU agency, not the legal authorising authority for every medicine.
2. The European Commission has legally defined decision-making responsibilities, including centralised marketing-authorisation decisions.
3. National competent authorities remain essential regulators within the EU system.
4. CHMP is the principal EMA scientific committee for human medicines within its mandate.
5. PRAC is the specialist EU committee for pharmacovigilance risk assessment.
6. CMDh coordinates specified matters concerning nationally authorised human medicines, particularly MRP and DCP procedures.

The practical consequence is straightforward: whenever a regulatory document is encountered, identify the legal procedure, institution, scientific output and legal effect before interpreting it.

References

1. European Union. Treaty on European Union and Treaty on the Functioning of the European Union, as amended.
2. European Parliament and Council. Regulation (EC) No 726/2004, as amended, establishing Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products and establishing the European Medicines Agency.
3. European Parliament and Council. Directive 2001/83/EC, as amended, on the Community code relating to medicinal products for human use.
4. European Medicines Agency. European Medicines Agency: role, responsibilities and organisation.
5. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP): role, responsibilities and procedures.
6. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC): role, responsibilities and procedures.
7. European Medicines Agency. Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh): role and procedures.
8. European Commission. EudraLex, Volume 1: Pharmaceutical legislation for medicinal products for human use.
9. European Commission. EudraLex, Volume 2: Notice to Applicants and regulatory guidance for medicinal products for human use.
10. European Commission. Rules and procedures applicable to the Union procedures for medicinal products for human use.

Regulatory Note

This article is an educational reference to the institutional architecture of the European medicines regulatory system. It distinguishes the functions of the European Commission, EMA, national competent authorities, CHMP, PRAC and CMDh, but it does not attempt to reproduce every statutory responsibility or every procedural exception.

The legal and procedural roles of these bodies depend on the applicable legislation and the particular regulatory procedure. A current assessment should therefore identify the applicable legal basis, product status, procedure and procedure-specific documents before drawing conclusions about institutional responsibility or legal effect.

EMA scientific opinions, committee recommendations, assessment reports and other scientific outputs should not automatically be treated as equivalent to a legally operative decision. Likewise, an EMA webpage or guidance document should not be assumed to have the same legal status as legislation or a binding regulatory act.

EU medicines legislation and regulatory procedures are amended and updated periodically. The current consolidated legislation, current EMA and Commission material, relevant CMDh guidance and the documents for the individual procedure should therefore be checked whenever this article is used for a live regulatory assessment.

Where there is a conflict between a general educational description and the applicable legislation or procedure-specific regulatory act, the applicable primary legal source and operative regulatory act take precedence.