GVP Module VII: Actions Taken and Regulatory Implications

Introduction

The PSUR is not simply a retrospective description of safety information. Its regulatory value depends on the ability to translate safety evaluation into appropriate conclusions and, where necessary, action.

GVP Module VII therefore distinguishes between actions already taken during the reporting interval and actions that may be proposed or required as a consequence of the current evaluation.

These are related but different questions.

The first asks:

What significant safety-related actions occurred during the reporting interval, and why?

The second asks:

What does the cumulative evaluation now indicate should happen next?

A robust PSUR makes both parts traceable and connects them to the underlying evidence.

1. Actions Taken During the Reporting Interval

The PSUR includes a specific section for significant actions related to safety taken worldwide during the reporting interval.

Under GVP Module VII, these can include actions taken by the marketing authorisation holder, clinical-trial sponsors, data monitoring committees, ethics committees or competent authorities where the action had a significant influence on the benefit-risk balance or affected the conduct of clinical development. citeturn0search12

The significance threshold matters. The purpose is not to create an exhaustive diary of every operational activity undertaken by a pharmacovigilance organisation.

The PSUR should communicate actions that materially matter to the safety evaluation.

2. Examples of Actions Concerning Investigational Use

Depending on the circumstances, significant actions can include:

• refusal to authorise a clinical trial for safety or ethical reasons;
• partial or complete suspension of a clinical trial;
• early termination of a trial because of safety findings or lack of efficacy;
• recall of an investigational medicinal product or comparator;
• changes to study protocols because of safety or efficacy concerns;
• restrictions in study population or indication;
• intensified subject monitoring;
• changes to informed-consent information arising from safety concerns;
• formulation changes;
• additional safety-reporting requirements imposed by regulators;
• communications to investigators or healthcare professionals; and
• plans for additional studies to address safety concerns.

The significance of an action should be understood in its clinical and regulatory context rather than inferred solely from the fact that it occurred.

3. Actions Concerning Marketing Experience

Significant actions associated with marketed use can include regulatory or organisational measures that materially affect the safety profile, availability, use or risk-management conditions of the product.

Examples can include:

• changes to product information for safety reasons;
• important risk-minimisation measures;
• safety communications;
• restrictions on use;
• suspension or withdrawal of a marketing authorisation;
• recalls or other significant product actions;
• changes arising from regulatory assessment;
• and other significant actions taken because of safety concerns.

The PSUR should explain the reason for an action where known and provide relevant updates to actions reported previously.

4. Why the Reason for an Action Matters

Listing an action without its rationale weakens the scientific value of the PSUR.

For example, a statement that a product's prescribing information was changed does not explain whether the change resulted from:

• a new adverse reaction;
• a change in the frequency or severity of a known reaction;
• new information about a special population;
• a regulatory assessment;
• a signal evaluation;
• or another safety consideration.

The reason connects the action to the safety narrative.

5. Actions Already Taken Versus Actions Now Proposed

These two categories should not be conflated.

An action taken during the reporting interval is part of the historical safety record being evaluated.

A proposed action arises from the current assessment of the cumulative evidence.

For example:

New safety evidence
        ↓
Assessment during reporting interval
        ↓
Action already taken
        ↓
Further cumulative evaluation
        ↓
PSUR conclusion
        ↓
Additional action proposed, continued action, or no action

The sequence allows the reader to understand how the safety issue evolved rather than seeing disconnected regulatory events.

6. Conclusions and Actions

GVP Module VII requires the PSUR to conclude on the implications of new information for the overall benefit-risk evaluation for each authorised indication and relevant subgroup where appropriate.

Based on cumulative safety data and benefit-risk analysis, the MAH should assess whether changes to the reference product information are needed and propose changes as appropriate. The conclusions can also include preliminary proposals to optimise or further evaluate the benefit-risk balance, including additional risk-minimisation activities where applicable. citeturn0search13

The conclusion therefore has an explicit action dimension.

It should answer not only:

What did we learn?

but also:

What does that learning require us to do?

7. Possible Outcomes

A PSUR conclusion may support different outcomes depending on the evidence.

Examples include:

• no change to the current safety profile or risk-management approach;
• continued routine monitoring;
• additional investigation;
• modification of risk-minimisation measures;
• additional pharmacovigilance activity;
• changes to product information;
• safety communication;
• regulatory variation or other regulatory procedure;
• restriction of use;
• suspension; or
• withdrawal where the applicable regulatory framework and evidence justify such action.

These outcomes should not be treated as a fixed hierarchy. The appropriate response depends on the nature, strength and clinical significance of the evidence.

8. No Action Is Also a Conclusion

A conclusion that no regulatory or risk-management change is required is not an absence of assessment.

Where an important safety issue was evaluated, the PSUR should provide sufficient reasoning to demonstrate why the evidence does not justify additional action at that point.

For example, a potential signal may have been investigated and found not to alter the current benefit-risk balance. The absence of action should then be the result of documented evaluation rather than omission.

This distinction is particularly important during inspection.

9. Proposed Product-Information Changes

Where the PSUR evaluation supports changes to the reference product information, those proposed changes should be clearly described in the relevant PSUR section and handled according to the applicable EU procedure.

EMA's current procedural advice states that, for EU single assessment procedures, proposed changes based on PSUR data are presented through the PSUR's EU regional appendix; the relevant product information is handled in accordance with the applicable submission requirements. citeturn0search0

The PSUR should therefore distinguish:

• evidence supporting the change;
• the clinical interpretation;
• the proposed wording or substantive change;
• and the regulatory mechanism through which the change will be implemented.

A proposed change is not itself the final regulatory decision.

10. Regulatory Assessment of the PSUR

The MAH submits the PSUR for regulatory assessment. The assessment may confirm the existing benefit-risk balance, identify a new risk, require further investigation or lead to action to protect public health. citeturn0search0

For substances subject to EU single assessment, the PSUSA procedure allows periodic safety information for medicines containing the same active substance or combination to be assessed together, including products under different marketing authorisations and in different Member States.

This provides an important regulatory distinction between the MAH's conclusion in the PSUR and the authority's subsequent regulatory assessment.

11. PSUR Conclusion Is Not the Regulatory Decision

The MAH may propose an action, but the final regulatory outcome depends on the applicable regulatory procedure and competent authority decision-making.

This distinction is essential when writing a PSUR.

A scientifically justified proposal should not be written as though the regulatory outcome has already occurred.

For example:

Appropriate:

The available evidence supports consideration of an amendment to the product information.

Potentially misleading:

The product information has been amended.

The second statement is appropriate only when the amendment has actually occurred.

12. Regulatory Implications Across the Product Lifecycle

PSUR findings can interact with many lifecycle processes.

A safety conclusion may lead to consideration of:

• product-information changes;
• RMP updates;
• additional PV activities;
• risk-minimisation changes;
• safety communications;
• variations;
• additional studies;
• or other regulatory procedures.

The PSUR should identify the implication without turning into a substitute for the detailed regulatory procedure governing the resulting action.

13. Relationship With the RMP

Where a product has an RMP, PSUR conclusions should be considered for their implications for the pharmacovigilance plan and risk-minimisation plan.

The current GVP Module VII specifically states that proposals arising from the PSUR should be considered for incorporation into the relevant pharmacovigilance and/or risk-minimisation plan, as appropriate. citeturn0search13

This creates an important governance interface:

PSUR evaluation
      ↓
Change in understanding of risk?
      ↓
RMP impact assessment
      ↓
PV / RMM changes where justified

A PSUR should therefore not be finalised without considering whether its conclusions create consequences for the current risk-management strategy.

14. Relationship With Signal Management

Signal management remains an ongoing process outside the PSUR reporting cycle.

A signal identified during the interval may have already resulted in action before the PSUR is completed. The PSUR then provides the periodic context in which the signal and resulting action are evaluated.

The PSUR should not delay urgent signal-management action merely because the information will later be discussed in a periodic report.

EMA has also updated its pharmacovigilance framework following Commission Implementing Regulation (EU) 2025/1466, with new legal requirements affecting MAH signal-management activities and corresponding GVP updates planned. Current operational processes should therefore be checked against the applicable implementation material. citeturn0search3turn0search1

15. Actions Affecting Clinical Development

The PSUR's actions-taken section can include significant safety-related decisions affecting investigational use as well as marketed use.

This is important because the safety profile of a medicinal product can evolve through evidence generated after initial authorisation, and clinical-development decisions may provide important evidence about how emerging concerns were managed.

Examples include changes to:

• study inclusion or exclusion criteria;
• dose or dosing regimen;
• monitoring requirements;
• treatment duration;
• study population;
• informed-consent information;
• or the continuation of a development programme.

The PSUR should describe the safety significance of the action rather than reproduce the complete operational history of the study.

16. Actions by Different Organisations

Safety-related actions may originate from different actors.

The MAH may take an action independently, while other actions may be initiated by:

• a competent authority;
• a clinical-trial sponsor;
• a data monitoring committee;
• an ethics committee;
• or another relevant regulatory or clinical-development body.

The PSUR should identify the nature of the action and its relevance to the product's safety evaluation.

This is particularly important when an action taken externally changes the assumptions under which the MAH's own safety monitoring is operating.

17. Regulatory Actions in Different Regions

The EU PSUR can contain information about significant worldwide safety actions.

A safety action taken outside the EU may therefore be relevant even when it has not produced an immediate EU regulatory change.

For example, a non-EU regulator may impose a warning, restriction, study requirement or product-information change based on evidence that is also relevant to the EU safety assessment.

The presence of different regulatory outcomes across jurisdictions should not automatically be interpreted as regulatory inconsistency. Differences may arise from:

• different approved indications;
• different populations;
• different product information;
• different exposure;
• different regulatory frameworks;
• different timing of evidence;
• or different procedural stages.

The PSUR should provide enough context for the reader to understand the significance of the international action.

18. Safety Communications as Actions

A significant safety communication can itself be an important safety action.

Examples include communications directed toward:

• healthcare professionals;
• investigators;
• patients;
• or other relevant stakeholders.

The PSUR should distinguish the communication from the evidence that triggered it.

A communication is a risk-management response; it does not itself establish that the underlying safety concern is causal or that the overall benefit-risk balance has become unfavourable.

The assessment should therefore connect:

Safety evidence
      ↓
Clinical/regulatory assessment
      ↓
Safety communication
      ↓
Subsequent evidence
      ↓
PSUR evaluation of effectiveness / implications

19. Actions Related to Risk Minimisation

Risk-minimisation actions may be routine or additional and may be modified in response to new evidence.

The PSUR should consider the significance of material changes such as:

• new or revised educational materials;
• changes in prescribing restrictions;
• controlled-distribution measures;
• additional monitoring requirements;
• changes to healthcare-professional communication;
• or other measures designed to reduce exposure to a known risk.

Where effectiveness information is available, the PSUR should distinguish between the implementation of a measure and evidence that it actually changes clinical outcomes or behaviour.

20. Regulatory Action and Benefit-Risk

A regulatory action should be interpreted in relation to the evidence and the regulatory question it addresses.

For example, a restriction of use may indicate that the regulator considers the product's benefits to remain relevant under narrower conditions rather than concluding that the medicine has no acceptable therapeutic role.

Similarly, a product-information change can communicate an updated understanding of a risk without implying that the entire benefit-risk balance has become unfavourable.

The PSUR should therefore avoid simplistic interpretations of regulatory actions.

21. When the Evidence Supports No Change

Sometimes the PSUR evaluation confirms that existing measures remain appropriate.

This is a substantive conclusion.

A useful explanation can identify:

• the safety concern considered;
• the evidence reviewed;
• the current understanding of the risk;
• the existing control measures;
• and why no additional action is justified at that time.

This makes a no-change conclusion auditable and prevents it from appearing to be a copy-forward statement.

22. When Further Investigation Is Needed

The PSUR may identify an evidence gap that cannot be resolved from existing information.

Further investigation may then be appropriate.

Depending on the question, this can involve:

• additional clinical analysis;
• targeted follow-up;
• epidemiological investigation;
• a PASS or other post-authorisation study;
• additional literature review;
• enhanced monitoring;
• or further signal evaluation.

The proposed investigation should have a clear scientific question rather than simply being described as "more data collection".

23. Regulatory Action and the RMP Lifecycle

A safety conclusion can require the RMP to evolve.

For example, a newly characterised risk may require:

• addition or modification of a safety concern;
• changes to important identified or potential risk characterisation;
• additional pharmacovigilance activity;
• additional risk minimisation;
• or modification of an existing effectiveness evaluation.

Conversely, cumulative evidence may justify reducing or removing an activity where the applicable regulatory framework permits it.

The PSUR should therefore act as an input into lifecycle governance rather than being treated as a document that ends when submitted.

24. PSUR and Product-Information Change Governance

Where a PSUR proposes a product-information change, the organisation should maintain a clear evidence trail.

A defensible chain is:

Safety observation
      ↓
Evidence assessment
      ↓
Clinical interpretation
      ↓
Benefit-risk implication
      ↓
Proposed product-information change
      ↓
Regulatory assessment
      ↓
Approved change
      ↓
Implementation and communication

The stages should not be collapsed into one another.

In particular, a proposal in a PSUR is not equivalent to an approved label change.

25. EU Single Assessment and Harmonisation

For PSURs subject to PSUSA, the regulatory assessment can consider information across multiple marketing authorisations containing the same active substance or combination.

This creates an important practical requirement for MAHs: the proposed safety interpretation should be capable of being understood across the products and indications within the procedure.

EMA's current procedural guidance states that the outcome of a PSUSA procedure can result in a legally binding decision or CMDh position and that resulting actions affecting marketing authorisations must be implemented in a harmonised and timely manner according to the applicable procedure. citeturn0search0

The PSUR preparation process should therefore anticipate the need for clear cross-product and regional information.

26. Actions Following PSUR Assessment

Once the PSUR has undergone regulatory assessment, the organisation should establish controlled processes for implementing the outcome.

Potential activities include:

• updating product information;
• implementing new risk-minimisation measures;
• updating the RMP;
• initiating or modifying studies;
• updating internal safety documents;
• communicating approved changes;
• and completing required regulatory submissions.

Implementation should be tracked to completion.

A regulatory decision that is correctly understood but not effectively implemented remains a pharmacovigilance-system risk.

27. The Difference Between Regulatory Decision and Implementation

Three distinct stages should be maintained:

1. Safety assessment — what the evidence means.
2. Regulatory decision — what the competent authority requires.
3. Implementation — how the MAH and relevant stakeholders put the decision into effect.

A robust governance system maintains traceability across all three.

For example, an authority may require a product-information change. The MAH then has to ensure that the required regulatory variation, artwork, systems, databases, communications and controlled documents are updated according to the applicable requirements.

28. Follow-Up and Effectiveness

Some regulatory actions require subsequent evaluation.

For example, after implementation of an additional risk-minimisation measure, later evidence may be needed to determine whether the intervention achieved its intended effect.

The next PSUR may therefore need to consider:

• whether the action was implemented;
• what evidence has become available;
• whether the risk changed;
• and whether further action is necessary.

This creates a lifecycle loop rather than a one-time response.

29. Practical Scenario: Regulatory Restriction Outside the EU

Suppose a regulator outside the EU restricts an indication because of a safety concern.

The MAH should not simply copy the foreign regulatory wording into the EU PSUR.

It should assess:

• the underlying evidence;
• whether the EU product has the same indication;
• whether the affected population exists in the EU;
• whether the exposure is comparable;
• whether the EU product information already addresses the concern;
• and whether EU regulatory action is warranted.

The foreign action is evidence and regulatory context; it is not automatically the EU conclusion.

30. Practical Scenario: A New Risk Requires Product-Information Change

Suppose cumulative evidence supports a clinically important new adverse reaction.

The PSUR should explain:

1. how the evidence was evaluated;
2. why the safety profile has changed;
3. how the change affects benefit-risk;
4. what product-information change is proposed;
5. whether RMP implications exist; and
6. whether additional risk-minimisation or pharmacovigilance action is required.

The regulatory procedure that follows then determines whether and how the proposed change is adopted.

31. Practical Scenario: No Action Despite a Potential Signal

Suppose a potential signal was evaluated but the cumulative evidence does not support a change in the safety profile.

A defensible conclusion should document:

• the evidence considered;
• the limitations;
• the reason the association remains unconfirmed;
• existing monitoring;
• and why additional action is not currently justified.

The conclusion should remain open to future reassessment as new evidence becomes available.

32. Inspection Perspective

Inspectors may ask:

• Which significant safety actions occurred during the reporting interval?
• How were they identified?
• Who assessed their significance?
• Can you show the rationale for each major action?
• How were actions reconciled with the safety database, signal system and regulatory records?
• How were proposed actions distinguished from completed actions?
• How were PSUR conclusions translated into RMP or product-information actions?
• How were regulatory decisions implemented?
• How was implementation effectiveness followed up?

The organisation should be able to reconstruct the lifecycle of a significant safety issue from evidence through action and follow-up.

33. Common Failure Modes

Potential deficiencies include:

• listing actions without explaining why they occurred;
• omitting significant international actions;
• treating every operational activity as a significant safety action;
• confusing proposed actions with completed regulatory decisions;
• failing to assess RMP implications;
• failing to track implementation of regulatory outcomes;
• failing to evaluate the effectiveness of important measures;
• and copying previous conclusions without reassessing whether actions remain appropriate.

These are illustrative process failures; whether a specific finding is regulatory depends on the circumstances and applicable requirements.

34. Governance of Regulatory Actions

A PSUR conclusion can initiate work across several parts of the pharmacovigilance and regulatory system. Governance should therefore identify ownership clearly.

A practical control model is:

The precise allocation of responsibilities varies by organisation, but accountability should remain unambiguous.

35. QPPV Oversight

QPPV oversight should extend beyond review of the final PSUR document.

The QPPV should have appropriate visibility of material safety conclusions, proposed actions and significant regulatory outcomes, particularly where they indicate a change in the safety profile or require substantial changes to the PV system or risk-management strategy.

Important escalation points can include:

• a new important safety concern;
• a significant change in benefit-risk;
• major product-information proposals;
• substantial additional risk-minimisation measures;
• regulatory restrictions;
• safety-related suspension or withdrawal;
• or failure to implement a required action.

The purpose is not for the QPPV to perform every operational task, but to ensure that significant safety and compliance implications receive appropriate oversight.

36. Vendor and Partner Interfaces

Where preparation or implementation activities are outsourced, the MAH remains responsible for ensuring that the applicable pharmacovigilance obligations are fulfilled.

Controls should therefore establish:

• who identifies significant safety actions;
• who maintains the regulatory-action inventory;
• who assesses PSUR implications;
• who owns proposed changes;
• who communicates regulatory outcomes;
• and who verifies implementation.

A vendor tracker should not become the only evidence that a safety action was understood and implemented.

37. Reconciliation of Safety Actions

A mature PSUR process should reconcile significant actions against relevant source systems.

Potential sources include:

• regulatory-intelligence records;
• safety governance minutes;
• signal-management records;
• RMP change records;
• product-information change control;
• clinical-development records;
• safety-communication records;
• and previous PSURs.

The purpose of reconciliation is not to force identical databases. It is to detect material omissions, inconsistencies and unexplained differences.

38. Maintaining a Regulatory-Action Inventory

A controlled regulatory-action inventory can be useful for products with substantial global activity.

A proportionate inventory might record:

• date;
• jurisdiction;
• authority or responsible organisation;
• product or indication affected;
• safety issue;
• action taken;
• rationale;
• implementation status;
• PSUR reporting period;
• related signal or safety concern;
• RMP impact;
• and product-information impact.

The inventory is an operational control. It should not replace the scientific narrative in the PSUR.

39. Avoiding Copy-Forward Errors

Previous PSURs are valuable sources of context, but their action sections should not be copied forward without reassessment.

For every material action, the current PSUR should establish whether it is:

• still active;
• completed;
• superseded;
• modified;
• or no longer relevant.

The same principle applies to proposed actions.

A proposal that appeared appropriate in a previous cycle may no longer be appropriate after new evidence becomes available.

40. Regulatory Actions and Data Lock Point

The DLP creates an important temporal boundary, but the relationship between the DLP and regulatory actions requires careful handling.

An action occurring before the DLP will ordinarily form part of the reporting-period history, subject to the applicable Module VII requirements.

Information becoming available after the DLP may still be relevant to the overall regulatory process and may require action outside the PSUR.

The organisation should therefore avoid the misconception that the DLP prevents it from acting on important safety information.

The DLP is a controlled reporting boundary, not a suspension of pharmacovigilance activity.

41. Actions Taken After the DLP

Where significant safety information or regulatory action arises after the DLP, the appropriate treatment depends on the circumstances and applicable regulatory requirements.

Potential considerations include:

• whether the information requires immediate escalation;
• whether it should be incorporated through an applicable PSUR process;
• whether it should be communicated separately;
• whether a variation or other regulatory procedure is required;
• and whether the information should be considered in subsequent periodic evaluation.

The decision should be documented rather than left to individual author judgement.

42. Regulatory Implications for Multiple Products

A safety conclusion may affect more than one product, indication or marketing authorisation.

The organisation should therefore assess the scope of the action carefully.

For example, a safety concern associated with an active substance may affect:

• multiple brands;
• different formulations;
• different indications;
• or products held by different MAHs within a group.

The appropriate regulatory consequences depend on the applicable authorisations and procedures.

The PSUR should identify the relevant scope without assuming that every product must receive an identical action.

43. International Regulatory Divergence

Different jurisdictions can reach different regulatory conclusions based on the same underlying evidence.

This should trigger assessment, not automatic harmonisation.

The MAH should understand the reasons for divergence, which may include:

• different benefit-risk contexts;
• different indications;
• different local product information;
• different legal standards;
• different timing;
• or different available evidence.

The PSUR should present significant differences accurately and explain their relevance to the EU evaluation.

44. When Regulatory Action Is Not Proportionate

Not every new safety observation warrants a regulatory change.

A proportionate response may instead be:

• continued routine monitoring;
• targeted follow-up;
• additional analysis;
• enhanced signal review;
• or inclusion in a future periodic assessment.

The important requirement is that the chosen response is justified by the evidence and clinical context.

45. Practical Scenario: Action Is Taken but Risk Does Not Increase

A regulator may introduce a precautionary restriction while the available evidence remains uncertain.

The action itself does not necessarily establish that the underlying risk has been quantified or that the overall benefit-risk balance is unfavourable.

The PSUR should report the action accurately and separately evaluate the underlying evidence.

This distinction prevents regulatory actions from being incorrectly treated as scientific evidence of causality.

46. Practical Scenario: Action Becomes Unnecessary

Cumulative evidence may eventually show that an additional measure is no longer required, where the applicable regulatory framework permits reassessment or removal.

The organisation should document:

• the evidence supporting reconsideration;
• the original reason for the measure;
• the evidence that has changed;
• and the regulatory process required to modify or remove it.

Again, the PSUR can provide evidence for the decision, but the relevant authority or procedure determines the regulatory outcome.

47. What an Inspection-Ready Process Looks Like

An inspection-ready organisation should be able to select a significant safety issue and demonstrate a coherent chain:

Initial observation
       ↓
Signal / safety assessment
       ↓
Risk-benefit interpretation
       ↓
Action taken
       ↓
PSUR evaluation
       ↓
Proposed / required action
       ↓
Regulatory decision
       ↓
Implementation
       ↓
Effectiveness / follow-up

The records do not need to be stored in one system. They need to be linked sufficiently for the organisation to reconstruct the decision history.

48. Final Review Questions

Before finalising the actions and regulatory implications section, ask:

1. Have all significant safety-related actions during the interval been identified?
2. Has the reason for each significant action been established where known?
3. Have relevant international actions been considered?
4. Have previous actions been updated rather than simply copied forward?
5. Are completed actions distinguished from proposals?
6. Have product-information implications been assessed?
7. Have RMP implications been assessed?
8. Have signal-management interfaces been considered?
9. Are urgent safety actions clearly separated from periodic reporting?
10. Can the organisation demonstrate implementation and follow-up of important regulatory outcomes?
11. Is the rationale for no action documented where appropriate?
12. Is the final conclusion consistent with the cumulative benefit-risk evaluation?

Key Takeaways

• The PSUR should distinguish significant actions already taken from actions proposed as a consequence of the current evaluation.
• Significant actions should be described with sufficient context to explain their safety and regulatory significance.
• A PSUR proposal is not the same thing as a regulatory decision.
• Regulatory decisions must be implemented through controlled processes and followed through to completion.
• Product-information, RMP, signal-management and risk-minimisation implications should be assessed coherently.
• No action can be a valid conclusion when supported by documented evaluation.
• International regulatory actions can be relevant even when EU action differs.
• The DLP is a reporting boundary, not a suspension of ongoing pharmacovigilance.
• Inspection readiness requires traceability from evidence through assessment, action, regulatory decision, implementation and follow-up.

References

1. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module VII — Periodic Safety Update Report.
2. European Medicines Agency. Periodic safety update reports (PSURs) and PSUR single assessment (PSUSA) procedural guidance.
3. European Medicines Agency. Explanatory note to GVP Module VII concerning PSUR single assessment.
4. European Commission. Commission Implementing Regulation (EU) No 520/2012, as amended.
5. European Parliament and Council. Directive 2001/83/EC, as amended.
6. Regulation (EC) No 726/2004, as amended.
7. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module V — Risk Management Systems.
8. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module XV — Safety Communication.
9. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module XVI — Risk Minimisation Measures.

Regulatory Note

This article is an educational explanation of actions taken and regulatory implications in the EU PSUR. It does not replace current GVP Module VII, applicable EU legislation, EMA procedural guidance, PSUSA guidance, the EURD list, regulatory decisions or an organisation's approved procedures.

Regulatory requirements and guidance may change. Before preparing, submitting or implementing actions arising from a PSUR, the current applicable legislation, GVP guidance, procedural requirements and regulatory outcome should be verified.

Examples and inspection considerations are illustrative unless an authoritative source is specifically identified.