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Pharmacovigilance Directive No. 932/2022

Ethiopian Food and Drug Authority932/2022

Summary

This directive establishes a pharmacovigilance system for monitoring adverse drug events, quality defects, and medication errors related to medicines. It outlines reporting procedures, investigation processes, and regulatory actions to ensure the safety, quality, and efficacy of medicines in Ethiopia. The directive also defines the roles and responsibilities of various stakeholders, including healthcare facilities, regulatory bodies, healthcare professionals, patients, and market authorization holders.

Who's affected

Manufacturers, importers, distributors, healthcare professionals, healthcare facilities, and patients involved with medicines in Ethiopia.

Action required

Healthcare professionals and facilities must report adverse drug events according to the procedures outlined in this directive. Patients are encouraged to report any suspected adverse events.

Key points

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  • Establishes a national pharmacovigilance system.
  • Mandates reporting of adverse drug events by healthcare professionals and facilities.
  • Defines reporting timelines for serious and non-serious adverse events.
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    • Outlines investigation procedures for adverse drug events.
    • Specifies regulatory actions to be taken by the authority.
    • Clarifies roles and responsibilities of various stakeholders.
    • Includes provisions for different types of reporting mechanisms.
    • Addresses penalties for non-compliance.

Requirements

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  • Reporting of adverse drug events by healthcare professionals and facilities.
  • Reporting of individual case safety reports (ICSRs), periodic safety update reports (PSURs), and other relevant safety information.
  • Investigation and analysis of reported adverse drug events.
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    • Implementation of regulatory actions based on investigation findings.
    • Establishment and maintenance of pharmacovigilance systems by market authorization holders.
    • Designation of a Qualified Person Responsible for Pharmacovigilance (QPPV) by market authorization holders.
    • Collaboration among stakeholders for effective pharmacovigilance.
    • Use of specified reporting mechanisms (yellow form, toll-free lines, mobile app, e-reporting).
    • Maintenance of confidentiality of reported information.

Rights and permissions

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  • The right to receive information on regulatory measures taken by the authority.
  • The right to obtain capacity building and training on pharmacovigilance and adverse drug event reporting.
  • The authority's right to conduct inspections and request information.
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    • The authority's right to take regulatory actions, including suspension or cancellation of market authorization.
    • The right to receive explanations on recommendations provided by the advisory committee.
    • The authority's right to share information on adverse drug events and signals with the public and other stakeholders.

Restrictions

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  • Traditional medicines and experimental medicines are not covered by this directive.
  • Non-standard abbreviations of drugs are not to be included in reports.
  • Information collected for pharmacovigilance purposes is confidential and should not be used for other purposes.
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    • Changes to product labeling, packaging, or formulation require prior authorization from the authority.
    • Market authorization holders must obtain authorization from the authority before implementing changes to product labeling, packaging, or formulation.
    • Dispensing of medicines with suspected product quality defects under investigation is prohibited.

Penalties

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  • Written warning for non-compliance with reporting responsibilities, orders, or failure to assign a pharmacovigilance focal person.
  • Temporary suspension of certificate of competency, license, or market authorization (three months to one year) for repeated offenses or failure to comply with orders to halt production, import, or recall a product, or for submitting false reports.
  • Cancellation of certificate of competency for committing offenses that warrant a warning or suspension within three years of a previous revocation.
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    • Order to recall, dispose of, or return a product from the market if it is determined to be unsafe.
    • Referral to other federal or regional bodies for action if the violator is not directly regulated by the authority.
    • Punishment according to regulations and directives for offenses not explicitly stated in this directive.

Objectives

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  • To establish a comprehensive pharmacovigilance system for medicines.
  • To ensure the safety, quality, and efficacy of medicines used in Ethiopia.
  • To detect, assess, understand, and prevent adverse effects and other medicine-related problems.
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    • To facilitate timely reporting and investigation of adverse drug events.
    • To define the roles and responsibilities of all stakeholders in pharmacovigilance.

Organizations

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  • Ethiopian Food and Drug Authority (EFDA)
  • Regional regulatory bodies
  • Ministry of Health
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    • World Health Organization (WHO)

Legal references

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  • Food and Medicine Administration Proclamation No. 1112/2019, Article 71 sub-article (2)
Original sourcehttps://justice.gov.et/en/directives/pharmacovigilance-directive-no-932-2022/
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