EudraVigilance:
Medicinal Product
Dictionary (EVMPD)
Prepared and Presented by –
Ms. Neha Jain
(Associate Professor)
Ms. Neha Jain (Associate Professor) 1
Introduction:
EudraVigilance Medicinal Product Dictionary
(EVMPD) is a centralized database managed by the
European Medicines Agency (EMA) designed to house
comprehensive information about medicinal products
marketed within the European Union (EU) and
European Economic Area (EEA).
EVMPD serves as a cornerstone in the
pharmacovigilance infrastructure of the EU, facilitating
the collection, management, and exchange of crucial
data necessary for the monitoring of the safety and
efficacy of medicinal products.
Ms. Neha Jain (Associate Professor) 2
Introduction:
Continued….
The database was established to address the need for
a standardized platform for the documentation of
medicinal product information, enhancing regulatory
oversight, and streamlining pharmacovigilance
processes across EU/EEA member states.
Understanding EVMPD is fundamental for
pharmacy professionals as it underpins the regulatory
framework governing medicinal products within the
EU/EEA, emphasizing the importance of accurate data
management and compliance with regulatory standards
for ensuring patient safety and public health.
Ms. Neha Jain (Associate Professor) 3
History:
Establishment: The EudraVigilance Medicinal
Product Dictionary (EVMPD) was established in 2005 by
the European Medicines Agency (EMA) as part of the
broader EudraVigilance system, which was developed to
facilitate the monitoring and reporting of adverse drug
reactions (ADRs) within the EU.
Context: The creation of EVMPD was driven by the
need for a standardized database to store detailed
information about medicinal products marketed in the
EU/EEA, enabling efficient pharmacovigilance activities
and regulatory oversight.
Ms. Neha Jain (Associate Professor) 4
History:
Continued….
Regulatory Framework: EVMPD was developed in
accordance with the regulatory requirements outlined in EU
legislation, including Directive 2001/83/EC and Regulation
(EC) No 726/2004, which govern the authorization,
supervision, and pharmacovigilance of medicinal products
within the EU.
Evolution: Since its inception, EVMPD has undergone
several updates and enhancements to align with evolving
regulatory standards and pharmacovigilance practices,
reflecting the dynamic nature of the pharmaceutical landscape
and the increasing importance of data transparency in ensuring
drug safety and public health.
Ms. Neha Jain (Associate Professor) 5
EVMPD (Users and Data Sources):
EVMPD comprises several key components that
collectively serve to provide a comprehensive repository
of information about medicinal products marketed within
the EU/EEA.
These components play a crucial role in facilitating
regulatory oversight, pharmacovigilance monitoring, and
data exchange among stakeholders involved in the
lifecycle management of medicinal products.
Ms. Neha Jain (Associate Professor) 6
EVMPD (Users and Data Sources):
Continued…
Product Information:
1. Product Information encompasses various details about
medicinal products, including their names, pharmaceutical
forms, routes of administration, strength, and packaging
details.
2. Names: EVMPD captures both brand names and generic
names of medicinal products, along with their
corresponding international non-proprietary names (INNs),
ensuring standardized nomenclature across the EU/EEA.
3. Pharmaceutical Forms: It includes information about the
different physical forms in which medicinal products are
available, such as tablets, capsules, injections, ointments,
and solutions.
Ms. Neha Jain (Associate Professor) 7
EVMPD (Users and Data Sources):
Continued…
Product Information:
4. Routes of Administration: EVMPD documents the routes
through which medicinal products are administered,
covering oral, topical, parenteral, inhalational, and rectal
routes, among others.
5. Strength: Detailed information about the concentration or
strength of active ingredients contained within medicinal
products is recorded in EVMPD, facilitating accurate dosing
and administration.
6. Packaging Details: EVMPD captures data regarding the
packaging configurations of medicinal products, including
pack sizes, container types, special packaging requirements,
and any associated labelling information.
Ms. Neha Jain (Associate Professor) 8
EVMPD (Users and Data Sources):
Continued…
Data Entry: Product information is entered into EVMPD by
marketing authorization holders (MAHs) or authorized users.
Verification: The entered data undergoes initial verification to
ensure completeness and accuracy.
Validation: The validated data is subjected to further
validation checks to verify compliance with regulatory
standards and formatting requirements.
Approval: Upon successful validation, the product
information is approved for storage in EVMPD.
Flowchart illustrates the process of capturing and
documenting product information in EVMPD.
Ms. Neha Jain (Associate Professor) 9
EVMPD (Users and Data Sources):
Continued…
Marketing Authorization Holder (MAH) Information:
Organization Details: EVMPD contains comprehensive
information regarding the organizations responsible for obtaining
marketing authorization and distributing medicinal products within
the EU/EEA. This includes details about the MAHs' corporate
structure, subsidiaries, and any relevant affiliations.
Contact Information: EVMPD provides contact details for
MAHs, including addresses, phone numbers, and email addresses.
This information facilitates communication and collaboration between
regulatory authorities, MAHs, and other stakeholders involved in
pharmacovigilance activities..
Ms. Neha Jain (Associate Professor) 10
EVMPD (Users and Data Sources):
Continued…
Pharmaceutical Product Identification (ID) Codes:
Unique Identification Codes: EVMPD assigns unique
identification codes to each medicinal product, such as the European
Article Number (EAN) or Global Trade Item Number (GTIN). These
codes serve as standardized identifiers that enable accurate tracking,
identification, and reporting of medicinal products across the
EU/EEA.
Standardized Coding Systems: EVMPD adheres to standardized
coding systems, such as the International Organization for
Standardization (ISO) standards, for assigning identification codes to
medicinal products. This ensures consistency, interoperability, and
compatibility with other regulatory and industry databases and
systems.
Ms. Neha Jain (Associate Professor) 11
EVMPD (Users and Data Sources):
Continued…
Lifecycle Events:
Variations and Updates: EVMPD records changes and updates
that occur throughout the lifecycle of medicinal products, including
variations in formulation, packaging, labeling, and regulatory status.
These variations may arise due to factors such as changes in
manufacturing processes, new safety information, or updates to
regulatory requirements.
Lifecycle Status: EVMPD tracks the lifecycle status of
medicinal products from initial registration through to market
authorization, renewals, suspensions, and withdrawals. This
includes documenting key milestones such as initial marketing
authorization, variations, renewals, and any regulatory actions or
decisions affecting the product's status.
Ms. Neha Jain (Associate Professor) 12
EVMPD (Users and Data Sources):
Continued…
Regulatory Classification:
Prescription Status: EVMPD categorizes medicinal products based on
their regulatory classification, indicating whether they are available by
prescription-only (Rx) or over-the-counter (OTC). This classification
reflects the level of regulatory control and patient access restrictions
associated with each medicinal product.
Regulatory Authorities: EVMPD documents the regulatory authorities
responsible for overseeing the marketing authorization, regulatory
compliance, and pharmacovigilance activities related to medicinal products
within the EU/EEA. This includes national competent authorities (NCAs)
in EU member states and the European Medicines Agency (EMA) at the
EU level.
Regulatory Updates: EVMPD captures changes in regulatory
classification and associated regulatory requirements throughout the
lifecycle of medicinal products, including variations in prescription status,
regulatory approvals, and labeling updates.
Ms. Neha Jain (Associate Professor) 13
EVMPD (Users and Data Sources):
Continued…
Regulatory Submissions: EVMPD serves as a repository for regulatory
submissions and notifications related to lifecycle events, including variations,
renewals, and withdrawals. Marketing authorization holders (MAHs) are
required to submit accurate and timely information to EVMPD to ensure
regulatory compliance and maintain the integrity of the database.
Compliance Monitoring: Regulatory authorities use EVMPD to monitor
compliance with regulatory requirements and assess the safety, efficacy, and
quality of medicinal products throughout their lifecycle. This includes
conducting periodic reviews, inspections, and audits to ensure that medicinal
products meet regulatory standards and requirements.
Transparency and Accountability: EVMPD promotes transparency and
accountability in the regulatory process by providing stakeholders with access
to comprehensive information about medicinal products and their lifecycle
events. This transparency enhances confidence in the regulatory system and
helps to ensure the timely identification and management of risks associated
with medicinal products.
Ms. Neha Jain (Associate Professor) 14
Importance of EVMPD in Pharmacovigilance:
Enhanced Pharmacovigilance
Monitoring: EVMPD plays a
pivotal role in enhancing Enhanced
Pharmacovigilance
pharmacovigilance monitoring by Monitoring
facilitating the systematic collection,
analysis, and reporting of adverse Improved
Streamlined
Public
drug reactions (ADRs) and other Health
Regulatory
Processes
Outcomes
safety-related data. By providing a Importance
centralized platform for the of EVMPD
aggregation and analysis of
pharmacovigilance data, EVMPD
enables regulatory authorities and Signal Detection
Harmonization
of Data
healthcare professionals to identify Standards
and assess potential safety concerns
associated with medicinal products
in a timely and efficient manner.
Ms. Neha Jain (Associate Professor) 15
Importance of EVMPD in Pharmacovigilance:
Continued…
Streamlined Regulatory Processes: EVMPD streamlines regulatory
processes related to pharmacovigilance activities, including product
registration, variation submissions, and compliance reporting for marketing
authorization holders (MAHs). By providing a standardized platform for data
exchange and regulatory submissions, EVMPD enhances the efficiency,
transparency, and consistency of regulatory procedures, thereby facilitating
timely regulatory decision-making and ensuring compliance with regulatory
requirements.
Improved Public Health Outcomes: Timely access to accurate and
comprehensive pharmacovigilance data in EVMPD supports evidence-based
decision-making by healthcare professionals, regulators, and policymakers,
ultimately contributing to improved patient safety and public health outcomes.
By providing stakeholders with access to reliable information about the safety,
efficacy, and quality of medicinal products, EVMPD helps to identify and
mitigate risks associated with the use of pharmaceutical therapies, thereby
safeguarding public health and enhancing patient care.
Ms. Neha Jain (Associate Professor) 16
Importance of EVMPD in Pharmacovigilance:
Continued…
Signal Detection: EVMPD supports signal detection activities by
enabling the identification of potential safety signals and emerging trends
through the analysis of aggregated pharmacovigilance data. By detecting
signals of previously unrecognized adverse effects or changes in the
frequency or severity of known adverse effects, EVMPD helps to inform
regulatory decisions, risk management strategies, and public health
interventions aimed at minimizing the risks associated with medicinal
products.
Harmonization of Data Standards: EVMPD promotes the
harmonization of data standards and practices across EU/EEA member
states by providing a standardized platform for the collection,
management, and exchange of pharmacovigilance data. By adhering to
common data standards and coding systems, EVMPD facilitates
interoperability and data exchange between regulatory authorities,
healthcare organizations, and industry stakeholders.
Ms. Neha Jain (Associate Professor) 17
Challenges and Future Directions:
Data Quality and Completeness: Ensuring the accuracy, completeness,
and consistency of data within EVMPD remains a significant challenge.
Issues such as data entry errors, incomplete submissions, and variations in
data quality across different sources can impact the reliability and utility of
EVMPD for pharmacovigilance purposes. Addressing these challenges
requires ongoing efforts to implement robust data management processes,
enhance data validation procedures, and provide training and support to
users responsible for entering and maintaining data within EVMPD.
Integration with Other Systems: Achieving seamless integration and
interoperability between EVMPD and other pharmacovigilance systems at
national and international levels is essential for facilitating data exchange,
analysis, and collaboration. Challenges may arise due to differences in data
formats, coding standards, and technical infrastructures between EVMPD
and external databases. Overcoming these challenges requires the
development of standardized data exchange protocols, harmonization of data
standards, and investment in interoperability initiatives aimed at promoting
seamless communication between disparate systems.
Ms. Neha Jain (Associate Professor) 18
Challenges and Future Directions:
Continued…
Evolving Regulatory Requirements: EVMPD must continue to evolve in
response to changing regulatory requirements and emerging
pharmacovigilance trends. This includes adapting to new legislative
frameworks, incorporating additional data elements or reporting requirements
mandated by regulatory authorities, and enhancing functionalities to support
advanced analytics, real-time monitoring, and predictive modeling.
Regulatory Compliance: Maintaining compliance with evolving
regulatory standards and requirements is paramount for all stakeholders
involved in the use and management of EVMPD. This includes adherence to
data privacy regulations, compliance with data submission deadlines, and
adherence to data quality standards mandated by regulatory authorities.
Additionally, ensuring transparency, accountability, and traceability in data
management processes is essential for building trust and confidence in the
integrity of EVMPD as a reliable source of information for pharmacovigilance
and regulatory decision-making purposes.
Ms. Neha Jain (Associate Professor) 19
Conclusion:
Summary: In summary, EudraVigilance Medicinal Product
Dictionary (EVMPD) stands as a vital component of the
pharmacovigilance infrastructure in the European Union (EU) and
European Economic Area (EEA). It serves as a centralized repository
for comprehensive information on medicinal products, facilitating
regulatory oversight, pharmacovigilance monitoring, and data
exchange among stakeholders.
Importance: Understanding EVMPD is essential for pharmacy
professionals as it underscores the significance of accurate data
management, regulatory compliance, and collaboration in ensuring
patient safety and public health. By providing timely access to
standardized product information, EVMPD supports evidence-based
decision-making, enhances risk management strategies, and contributes
to improved public health outcomes across the EU/EEA region.
Ms. Neha Jain (Associate Professor) 20
Conclusion:
Future Perspectives: The future of EVMPD hinges on ongoing
efforts to address challenges related to data quality, interoperability,
and regulatory compliance, while also embracing opportunities for
innovation and collaboration. As regulatory requirements evolve and
technological advancements continue to reshape the
pharmacovigilance landscape, EVMPD must remain agile and
adaptable to meet emerging needs and expectations.
Call to Action: As pharmacy professionals, it is imperative to stay
informed about the latest developments and best practices in
pharmacovigilance, including the role of EVMPD in supporting
regulatory compliance and patient safety initiatives. By actively
engaging in training, education, and professional development
activities, we can contribute to the effective utilization of EVMPD
and promote the continued advancement of pharmacovigilance
practices in the EU/EEA and beyond.
Ms. Neha Jain (Associate Professor) 21
THANK YOU
~ Ms. Neha Jain
(Associate Professor )
Ms. Neha Jain (Associate Professor) 22
