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What Is a Marketing Authorisation in the EU?

An in-depth guide to the EU marketing authorisation as the legal framework governing the placing of a medicinal product on the market, from the evidence base and benefit-risk assessment through authorised conditions of use and continuing obligations.

Audio Lesson 27 min

What Is a Marketing Authorisation in the EU?

Introduction

A marketing authorisation is the legal authorisation that permits a medicinal product to be placed on the market under defined conditions.

That definition is easy to state but important to understand precisely. An authorisation is not simply a certificate saying that a medicine has been "approved". It establishes the legal and regulatory conditions under which a particular medicinal product may be marketed and used.

The authorisation follows an assessment of evidence concerning the product's quality, safety and efficacy and the relationship between its benefits and risks. It also creates continuing obligations for the marketing authorisation holder (MAH).

The central idea is:

A marketing authorisation is a legal regulatory status attached to a defined medicinal product, indication and conditions of use. It is based on an assessment of evidence and remains subject to continuing regulatory oversight.

The authorisation should therefore be understood as the point at which a medicine enters a regulated lifecycle, not as the point at which regulatory scrutiny ends.

1. What Does a Marketing Authorisation Permit?

At its most basic level, a marketing authorisation permits the holder to place the medicinal product on the market within the scope of the authorisation.

The important qualification is within the scope of the authorisation.

A medicine is not authorised in the abstract. The authorisation relates to defined characteristics of the product and its use, which can include:

The regulatory question is therefore not merely whether a medicine is "approved". It is:

What product has been authorised, for which use, under which conditions, and on what regulatory basis?

2. A Marketing Authorisation Is Product-Specific

A marketing authorisation applies to a defined medicinal product.

Two products containing the same active substance are not necessarily the same regulatory product. They can differ in pharmaceutical form, strength, route of administration, formulation, manufacturing arrangements, indications, target populations or other characteristics.

For that reason, a regulatory conclusion concerning one authorised product should not automatically be transferred to another product simply because both contain the same active substance.

The authorisation must be read in its own scope.

This is particularly important in pharmacovigilance. A safety issue may concern a substance broadly while the regulatory consequence applies only to particular strengths, formulations, indications or populations.

3. A Marketing Authorisation Is Condition-Specific

The authorised medicine is not simply a chemical entity.

It is a medicinal product authorised for defined conditions of use.

For example, an authorisation may specify:

The benefit-risk conclusion therefore has boundaries.

A medicine may have a favourable benefit-risk balance for one indication and not for another. Likewise, a particular dose or duration may be acceptable while a different exposure is not.

This is why the phrase "the medicine is authorised" is incomplete without considering what exactly has been authorised.

EU marketing authorisations operate within the Union pharmaceutical legal framework.

For human medicines, two central legislative instruments are Directive 2001/83/EC and Regulation (EC) No 726/2004, as amended.

Directive 2001/83/EC establishes the Community code relating to medicinal products for human use and contains provisions governing, among other matters, marketing authorisation and national procedures.

Regulation (EC) No 726/2004 establishes Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products within its scope and provides the legal foundation for the centralised procedure.

The applicable route depends on the product and the legal framework.

The important distinction is that EMA itself does not create the general legal concept of a marketing authorisation. The authority and legal effect of an authorisation derive from the applicable EU and national legislation.

5. The Four Main Authorisation Routes

The EU medicines system provides several routes through which medicinal products can obtain marketing authorisation:

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

These routes differ in how applications are assessed, which authorities participate and where the resulting authorisation operates.

They should not be confused with four different standards of pharmaceutical quality or clinical evidence. The underlying EU regulatory framework establishes common requirements, although the precise procedural requirements depend on the application and legal route.

The previous article in this series explains these routes in detail. Here the important point is that marketing authorisation is a regulatory status that can be reached through different procedural architectures.

6. Centralised Marketing Authorisation

Under the centralised procedure, an applicant submits a single application for Union-level scientific assessment.

For human medicines within its remit, the Committee for Medicinal Products for Human Use (CHMP) performs the scientific assessment through the EMA system and adopts a scientific opinion.

The European Commission then adopts the legally binding Union decision on the marketing authorisation.

A centralised marketing authorisation is valid throughout the EU and, under the applicable arrangements, in Iceland, Liechtenstein and Norway.

The simplified sequence is:

Application
    ↓
Scientific assessment
    ↓
CHMP opinion
    ↓
European Commission decision
    ↓
Centralised marketing authorisation

The distinction between the scientific opinion and the legal decision is fundamental. CHMP's scientific conclusion and the Commission's legally operative decision are related, but they are not the same legal act.

7. National Marketing Authorisation

A medicinal product can also be authorised nationally.

In a national procedure, the relevant national competent authority assesses the application and grants the marketing authorisation under the applicable national and EU legal framework.

The resulting authorisation applies within that Member State.

If the applicant subsequently seeks authorisation in additional Member States, the mutual recognition or decentralised procedure may become relevant, depending on the circumstances.

A national marketing authorisation is therefore part of the EU medicines regulatory system even though the authorisation decision is taken by a Member State authority.

EU medicines regulation should not be equated with centralised regulation.

8. Mutual Recognition and Decentralised Procedures

The mutual recognition procedure is used when 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.

The Member State whose existing assessment is relied upon is the Reference Member State (RMS), while the participating states are Concerned Member States (CMSs).

The decentralised procedure is used when the product has not yet received a national marketing authorisation in the participating Member States and the applicant seeks authorisation in several Member States simultaneously.

The RMS coordinates the assessment and the CMSs participate in the procedure.

The resulting national authorisations are issued by the participating Member States.

These procedures show why a European regulatory framework can operate through national authorities without requiring every medicine to receive a centralised Union authorisation.

9. What Is Actually Being Assessed?

A marketing-authorisation application contains evidence addressing several dimensions of the medicinal product.

At a high level, the regulator must assess:

These dimensions cannot always be considered independently.

Questions can include:

The final regulatory conclusion is therefore an integrated assessment rather than a simple pass/fail test of one dataset.

10. Quality

Quality concerns whether the medicinal product can be consistently manufactured and controlled to the required standards and whether its relevant pharmaceutical characteristics are adequately established.

Quality assessment can include:

The purpose is not merely to establish that one tested batch was acceptable. The regulatory system requires an appropriate basis for confidence that the product can be manufactured consistently throughout its authorised lifecycle.

Quality is therefore part of the medicinal product's benefit-risk framework, not a separate commercial concern.

11. Safety

Safety assessment examines adverse effects and other risks associated with the medicinal product.

Relevant evidence can come from non-clinical studies, clinical trials, pharmacological knowledge, epidemiological evidence where available and other scientifically relevant sources.

At the time of initial authorisation, however, the safety profile is necessarily incomplete.

Clinical development cannot reliably identify every rare event, long-latency outcome or effect in every population that may eventually use the medicine.

This limitation is one reason the marketing authorisation is accompanied by continuing pharmacovigilance obligations.

Authorisation therefore does not mean that the regulator has concluded that the product has no risks. It means that the risks identified and the remaining uncertainties have been assessed within the applicable regulatory framework.

12. Efficacy

Efficacy concerns whether the medicinal product provides the claimed therapeutic benefit under the conditions studied and proposed for authorisation.

Evidence may include:

The regulatory question is not simply whether an effect can be demonstrated under any circumstances.

The evidence must support the proposed therapeutic claims and conditions of use to the standard required by the applicable regulatory framework.

13. Benefit-Risk Balance

Quality, safety and efficacy come together in the benefit-risk assessment.

A medicine can have important adverse effects and nevertheless have a favourable benefit-risk balance. Conversely, a relatively uncommon adverse reaction can have substantial regulatory significance if the consequence is severe, the therapeutic benefit is limited, the exposed population is vulnerable or effective alternatives exist.

The central question is therefore not:

"Does the medicine have risks?"

All medicines have risks.

The relevant question is whether the benefits are sufficient to outweigh the risks under the proposed conditions of use.

That assessment continues after authorisation as new evidence becomes available.

14. Benefit-Risk Is Contextual

Benefit-risk is not a fixed property that can be separated from the circumstances of use.

Relevant considerations can include:

The same adverse reaction can therefore have different regulatory significance in different therapeutic contexts.

This does not mean that the safety standard changes according to the disease. It means that the regulatory assessment weighs the magnitude and importance of benefit against the magnitude and importance of risk for the proposed use.

15. Regulatory Decisions Are Made Under Uncertainty

A marketing authorisation does not mean that every scientific question about a medicine has been resolved.

At initial authorisation, some uncertainty may remain concerning rare adverse reactions, long-term exposure, specific subpopulations or other matters.

The regulator must decide whether the available evidence is sufficient to support authorisation under specified conditions.

Remaining uncertainties can be addressed through continuing evidence generation and regulatory oversight, including:

The presence of uncertainty is therefore not, by itself, evidence that the original authorisation was inappropriate.

16. The Marketing Authorisation Dossier

The marketing authorisation is supported by a structured regulatory dossier containing evidence about the medicinal product.

For applications using the Common Technical Document (CTD) format, the dossier is organised into five modules:

The exact dossier requirements depend on the application type and applicable legislation.

The CTD structure is important because it demonstrates that the regulatory conclusion rests on an integrated evidence package rather than on a single clinical study or safety dataset.

17. Module 1: Administrative and Regional Information

Module 1 contains region-specific administrative and prescribing information.

For EU applications, this includes regulatory material such as application documentation and product information, together with other information required under the applicable framework.

The contents vary according to the application.

Module 1 is particularly relevant to understanding how the scientific assessment is translated into the regulatory documentation that governs the authorised product.

18. Module 2: Summaries

Module 2 contains high-level summaries of the evidence in the more detailed parts of the dossier.

These include summaries relating to:

The summaries provide an integrated presentation of the scientific argument.

They do not replace the underlying study reports and technical documentation. They are intended to allow the assessor to understand the principal findings and conclusions before examining the detailed evidence.

19. Module 3: Quality

Module 3 contains detailed pharmaceutical and quality information.

Depending on the product, this can cover:

The objective is to establish an appropriate scientific and manufacturing basis for consistent product quality.

20. Module 4: Non-Clinical Evidence

Module 4 contains non-clinical study reports.

Depending on the product and development programme, these can address areas such as:

Non-clinical evidence contributes to understanding pharmacological activity and potential hazards and informs the interpretation of the subsequent human evidence.

21. Module 5: Clinical Evidence

Module 5 contains the detailed clinical evidence supporting the proposed use of the medicine.

This can address:

The clinical evidence is integrated with the quality and non-clinical evidence rather than assessed in isolation.

The regulatory conclusion depends on the totality of relevant evidence and the question being addressed.

22. The Product Information

The authorised product information translates important parts of the regulatory conclusion into information governing the use of the medicine.

For human medicines, important components include:

The SmPC is particularly important for healthcare professionals. It includes information such as indications, posology, contraindications, warnings and precautions, interactions, adverse reactions and relevant pharmaceutical and pharmacological information.

The product information is therefore not simply promotional or educational material. It is a controlled regulatory output reflecting the authorised conditions of use.

23. Conditions of Use Can Be Regulatory Controls

The conditions attached to an authorisation can be important tools for managing benefit-risk.

Depending on the evidence and legal framework, regulatory controls can include:

The existence of such conditions should not be interpreted as evidence that a medicine is either completely safe or intrinsically unsafe. They reflect the regulator's assessment of how the medicine should be used within its authorised benefit-risk framework.

24. The Marketing Authorisation Holder

The marketing authorisation holder is the person or legal entity holding the marketing authorisation.

The MAH has continuing responsibilities under the applicable regulatory framework. These extend beyond the submission that led to the original authorisation.

Depending on the product and legal route, responsibilities can include:

The precise obligations must be determined from the applicable legislation and the conditions of the individual authorisation.

25. Authorisation Is the Beginning of a Regulatory Lifecycle

Once a medicine is authorised, new evidence continues to accumulate.

That evidence can come from:

The marketing authorisation can consequently be maintained, varied, restricted or otherwise affected as the evidence and regulatory context evolve.

A useful model is:

Evidence before authorisation
          ↓
Scientific assessment
          ↓
Regulatory decision
          ↓
Marketing authorisation
          ↓
Post-authorisation evidence
          ↓
Regulatory reassessment
          ↓
Authorisation maintained or changed

The next part of this article will examine what the authorisation actually contains, how its legal scope is defined, what continuing obligations follow from it, and how changes to the authorised medicine are handled during the lifecycle.

23. The Marketing Authorisation Holder

The marketing authorisation holder (MAH) is the person or legal entity holding the authorisation.

The MAH has continuing responsibilities after authorisation. The authorisation does not transfer responsibility for the product to EMA, a national competent authority or the European Commission.

Depending on the product and applicable legislation, the MAH must maintain systems and processes covering areas such as:

The exact obligations depend on the authorisation and the applicable legal framework.

A useful distinction is therefore:

The authority grants and supervises the authorisation; the MAH remains responsible for complying with the obligations attached to holding it.

24. The Authorisation Is a Living Regulatory Instrument

A marketing authorisation should not be regarded as a static document.

The authorised product can change during its lifecycle, and the regulatory framework provides procedures for controlling those changes.

Changes may concern:

The appropriate regulatory procedure depends on the nature and significance of the change.

This is the practical meaning of lifecycle regulation: the authorised state of the medicine is maintained through continuing regulatory oversight.

25. Variations to the Marketing Authorisation

A variation is a regulatory mechanism for changing an existing marketing authorisation.

The EU variation system classifies changes according to their regulatory significance and establishes procedures for their assessment and implementation.

At a high level, changes can include:

The detailed classification and procedural requirements are governed by the applicable variation legislation and guidance.

The important principle is that an MAH cannot simply change an authorised condition because new evidence or a business decision makes the change desirable.

Where the change affects the terms of the marketing authorisation, the appropriate regulatory procedure must be followed.

26. Renewals

The regulatory lifecycle can also include renewal procedures where required by the applicable legal framework.

A renewal can involve consideration of the product's continued benefit-risk balance and relevant information accumulated since the original authorisation or previous regulatory assessment.

The precise renewal requirements differ according to the type of authorisation and current legislation.

A renewal should therefore not be described as merely an administrative extension without considering the legal framework governing the particular authorisation.

27. Pharmacovigilance After Authorisation

The evidence available at the time of authorisation is necessarily incomplete.

Once a medicine is used in a larger and more diverse population, additional information becomes available.

Sources can include:

This evidence is evaluated through the pharmacovigilance system.

A new safety report does not automatically mean that the marketing authorisation must change. The information has to be assessed in context, including the strength of the evidence, the background incidence of the event, the characteristics of the exposed population and the overall benefit-risk balance.

28. Signal Detection and Regulatory Assessment

A pharmacovigilance signal is information suggesting a new potentially causal association, or a new aspect of a known association, that warrants further investigation.

Signal detection is therefore not equivalent to establishing causality.

A simplified sequence is:

New information
      ↓
Signal detection
      ↓
Validation and assessment
      ↓
Further evidence review
      ↓
Regulatory conclusion
      ↓
Action, if justified

Possible regulatory outcomes vary according to the evidence and applicable procedure.

They can include continued monitoring, changes to product information, additional risk-minimisation measures, further studies or other regulatory action.

29. Risk Management

Risk management is another continuing component of the marketing authorisation lifecycle.

For products within the applicable EU requirements, the Risk Management Plan (RMP) describes important identified risks, important potential risks and missing information, together with the pharmacovigilance and risk-minimisation activities used to address them.

Risk management is not limited to listing adverse reactions.

Its purpose is to identify and characterise important risks and establish measures proportionate to the evidence and regulatory need.

The RMP can therefore change as the evidence base changes.

30. Routine and Additional Risk Minimisation

Risk minimisation can be achieved through routine measures incorporated into normal product use and, where necessary, additional measures.

Routine measures can include information contained in:

Additional measures may be introduced where routine measures are insufficient to address a particular risk.

Examples can include controlled educational or monitoring arrangements, subject to the requirements applicable to the particular product.

The existence of a risk does not automatically mean that an additional measure is required. The regulatory decision depends on the nature of the risk, the available evidence and the effectiveness of existing measures.

31. When the Benefit-Risk Balance Changes

A medicine's benefit-risk balance can change after authorisation.

Possible reasons include:

The appropriate regulatory response depends on the significance and reliability of the new evidence.

The response can range from no change to modification of the authorised conditions, additional monitoring, restrictions or other action available under the applicable legal framework.

32. Product Information Changes

When a regulatory assessment changes the authorised conditions of use, the product information may need to be updated.

A safety assessment, for example, can result in changes to:

The change to the SmPC is therefore not the scientific assessment itself. It is the controlled regulatory expression of the resulting conclusion.

This distinction is useful when reconstructing why a particular product-information statement exists.

33. The Package Leaflet

The package leaflet communicates information about the medicine to patients and users.

It is based on the authorised product information and is subject to regulatory requirements.

When a regulatory decision changes information relevant to patients, the package leaflet may need to change accordingly.

The leaflet should therefore be treated as part of the controlled regulatory information for the medicine rather than as an independent patient-communication document.

34. Manufacturing and Quality Changes

The marketing authorisation also controls important aspects of pharmaceutical quality and manufacture.

Changes to manufacturing arrangements may require regulatory assessment before they can be implemented, depending on the nature of the change.

Relevant areas can include:

The purpose is to ensure that an authorised medicine remains within the required quality framework after the change.

35. Post-Authorisation Studies

Additional studies may be required or undertaken after authorisation to address specific questions.

These can include post-authorisation safety studies and other studies appropriate to the product and regulatory question.

The existence of a post-authorisation study does not necessarily mean that the medicine has an unfavourable benefit-risk balance.

It may instead reflect a need to reduce uncertainty or obtain information that cannot reasonably be generated before or at the time of initial authorisation.

36. Referrals and the Marketing Authorisation

Some regulatory questions require assessment through a formal referral procedure.

Referral procedures have specific legal bases and triggers. They are not a generic mechanism for every regulatory concern.

Depending on the procedure, a referral can result in conclusions affecting:

The legal effect of the outcome depends on the particular referral mechanism and the final regulatory instrument.

37. The Difference Between Scientific Opinion and Authorisation

One of the most important concepts in EU regulatory affairs is the distinction between a scientific committee's conclusion and the legally operative authorisation.

For the centralised procedure:

Scientific assessment
        ↓
CHMP opinion
        ↓
European Commission decision
        ↓
Legally operative authorisation

The CHMP opinion is an important scientific regulatory output, but it should not automatically be described as the marketing authorisation itself.

This distinction becomes particularly important when analysing variations, referrals and post-authorisation safety decisions.

38. The Authorised Conditions Are the Regulatory Baseline

Once an authorisation is granted, the authorised conditions become the baseline against which subsequent changes are assessed.

For example, if the authorised indication is changed, the regulatory team needs to identify:

  1. the previous authorised indication;
  2. the regulatory basis for the change;
  3. the effective date;
  4. the revised product information;
  5. implementation requirements.

This is more reliable than relying on informal descriptions such as “the indication was narrowed.”

The actual regulatory documents establish what changed and when.

39. Regulatory Status and Effective Dates

A regulatory decision and its implementation do not always occur at the same moment.

Depending on the procedure, there may be:

A regulatory professional should therefore establish which date has which legal significance.

This is particularly important when determining when an MAH must implement a change.

40. The Authorisation and Commercial Supply

A marketing authorisation permits marketing within its scope, but authorisation alone does not guarantee that a product will be commercially supplied everywhere at all times.

Supply can be affected by matters such as:

These matters should not be confused with the legal existence or scope of the marketing authorisation.

41. Marketing Authorisation Versus Market Access

Marketing authorisation and market access are related but distinct concepts.

A marketing authorisation establishes that the medicinal product may be marketed under the applicable regulatory framework.

Market access involves additional questions concerning whether and how the product is made available within a particular healthcare system.

Depending on the Member State, additional processes can include:

These processes are outside the core scientific and legal concept of marketing authorisation.

42. Marketing Authorisation Does Not Mean Universal Use

A medicine can be authorised while still being subject to restrictions on its use.

The authorisation may specify:

Healthcare use outside those conditions raises separate clinical, legal and regulatory questions and should not be described simply as an extension of the marketing authorisation.

43. Generic and Hybrid Applications

Not every marketing authorisation application requires the applicant to generate a completely new clinical development programme.

EU legislation provides specific pathways for certain applications, including generic and hybrid applications, subject to their statutory requirements.

A generic application can rely on the regulatory framework associated with a reference medicinal product where the legal conditions are met.

A hybrid application is used where the statutory requirements for a conventional generic application are not sufficient and additional evidence is required.

The precise legal criteria and data requirements depend on the application type.

The important point is that the evidence supporting an authorisation depends on the legal basis of the application.

44. Biosimilar Marketing Authorisations

Biological medicines require a different regulatory approach from conventional small-molecule generics.

A biosimilar is a biological medicinal product that is highly similar to an already authorised reference biological medicine, with the regulatory assessment designed to establish that there are no clinically meaningful differences in relevant quality, safety or efficacy characteristics.

The evidence package is therefore not identical to that of a generic medicine.

EMA and EU legislation provide specific requirements for biosimilar development and assessment.

45. Orphan Medicines and Special Regulatory Frameworks

Certain medicinal products are subject to additional or specialised regulatory provisions.

Orphan medicinal products are one example.

Other specialised frameworks can apply to particular categories of medicines or development situations.

The existence of a special designation or framework does not remove the need for an appropriate benefit-risk assessment.

It changes aspects of the regulatory pathway or the incentives and requirements associated with development and authorisation.

46. Conditional and Exceptional Regulatory Mechanisms

EU legislation also provides specialised mechanisms for situations in which the normal evidence package or public-health circumstances justify a different regulatory approach.

Examples include conditional marketing authorisation and exceptional circumstances frameworks, where the applicable legal criteria are met.

These mechanisms should not be described as lower regulatory standards.

They are specific legal frameworks for managing particular evidentiary or public-health circumstances, including mechanisms for addressing remaining obligations or uncertainties.

The precise criteria must be established from the current legislation.

47. What a Marketing Authorisation Does Not Establish

A marketing authorisation should not be interpreted as establishing any of the following propositions automatically:

The authorisation establishes a legally defined permission to market the medicinal product under specified conditions following the applicable regulatory assessment.

That is the more accurate interpretation.

48. How to Read a Marketing Authorisation Properly

When reviewing an authorisation, start with the operative documents rather than a secondary summary.

Identify:

  1. the authorised product;
  2. the MAH;
  3. the legal basis and procedure;
  4. the authorised indication;
  5. the pharmaceutical form and strength;
  6. the authorised conditions of use;
  7. the product information;
  8. any restrictions or special conditions;
  9. any post-authorisation obligations;
  10. the date on which the relevant regulatory act takes effect.

This approach is particularly useful when regulatory information has changed over time.

49. How to Reconstruct the Regulatory History

For a mature product, the current authorisation may represent the cumulative result of many regulatory procedures.

A useful reconstruction is:

Initial authorisation
        ↓
Variations
        ↓
Safety assessments
        ↓
RMP updates
        ↓
Additional evidence
        ↓
Further variations / referrals
        ↓
Current authorised state

The current product information tells you what is authorised now.

The regulatory history explains how that authorised state was reached.

Both can be necessary when assessing a regulatory question.

50. The Marketing Authorisation as a Lifecycle Contract

A useful way to understand the concept is to regard the marketing authorisation as a structured regulatory relationship.

The authority establishes the legal conditions under which the medicine may be marketed.

The MAH accepts continuing obligations associated with maintaining that authorisation.

The regulatory system continues to evaluate new evidence and can modify the authorised conditions when justified.

This is not a literal contractual relationship in the private-law sense. It is a conceptual model for understanding the continuing nature of the regulatory framework.

The central idea is:

Authorisation establishes a controlled regulatory state, not a permanent exemption from further scrutiny.

51. A Practical Framework for Regulatory Professionals

When asked whether a medicine is “authorised” in the EU, avoid answering with a simple yes or no.

Establish:

Then identify the governing regulatory document.

This is the level of precision required for reliable regulatory work.

52. The Key Concept

A marketing authorisation is best understood as the legally defined permission to market a particular medicinal product under specified conditions, following the applicable assessment of quality, safety, efficacy and benefit-risk balance.

Its significance does not end when the authorisation is granted.

The medicine remains subject to:

That lifecycle perspective is essential to understanding the EU medicines system.

The next article examines the four principal authorisation routes in greater detail: Centralised, National, Mutual Recognition and Decentralised Procedures Explained.

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 medicinal products for human use, including marketing authorisation, mutual recognition, decentralised procedures, product information and pharmacovigilance.
  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. Pharmaceutical legislation. Current Commission material concerning the EU legal framework for medicinal products.
  4. European Medicines Agency. The European regulatory system for medicines. Current EMA material describing the European medicines regulatory network and the relationship between EMA and national competent authorities.
  5. European Medicines Agency. Marketing authorisation. Current information concerning marketing-authorisation procedures and regulatory assessment.
  6. European Medicines Agency. Applying for marketing authorisation. Current information concerning application procedures and scientific assessment for human medicines.
  7. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Current information concerning CHMP responsibilities and scientific opinions.
  8. European Medicines Agency. Generic medicines. Current information concerning the EU regulatory framework for generic medicinal products.
  9. European Medicines Agency. Biosimilar medicines. Current information concerning the scientific and regulatory principles applicable to biosimilar medicines.
  10. European Medicines Agency. Orphan designation. Current information concerning the EU orphan-medicinal-product framework.
  11. European Medicines Agency. Risk-management plans. Current information concerning risk-management planning and the continuing benefit-risk assessment of medicines.
  12. European Medicines Agency. Referral procedures for human medicines. Current information concerning Union referral procedures and their regulatory context.
  13. European Commission. Variations guidelines and applicable variation legislation. Current material concerning changes to the terms of marketing authorisations.
  14. European Medicines Agency. Good Pharmacovigilance Practices (GVP). Current guidance concerning pharmacovigilance systems, signal management and post-authorisation safety activities.

Primary-document hierarchy

For a live regulatory question, use the source that has legal or procedural authority for the particular issue. A practical hierarchy is:

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

The hierarchy is not absolute for every factual question. Scientific reasoning may be best understood from an assessment report, while the legal effect of an action should be established from the applicable legal instrument.

Regulatory Note

This article is an educational and regulatory-reference document. It explains the concept of a marketing authorisation in the European Union and is intended to provide a foundation for understanding the more specialised authorisation procedures and post-authorisation processes discussed elsewhere in this series.

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

The EU medicines framework changes over time. Legislative amendments, implementing measures, procedural guidance and regulatory practice should therefore be checked against current official sources when a live regulatory decision is being made.

The article distinguishes the general concept of marketing authorisation from the particular legal requirements applicable to different products and procedures. The exact scope of an authorisation, its conditions, obligations, restrictions and effective dates must be established from the current regulatory record for the medicine concerned.

A marketing authorisation is not a statement that a medicine is free from risk, appropriate for every patient or permanently fixed in its authorised form. It is a legally defined regulatory status that remains subject to continuing scientific assessment and the post-authorisation obligations established by EU law.

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

Revision History

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Last reviewed: 2026-08-23