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Medicine Marketing Authorization Directive No. 963/2023

Ethiopian Food and Drug Authority963/2015

Summary

This directive, No. 963/2015, establishes the procedures and requirements for obtaining marketing authorization for medicines in Ethiopia. It outlines general principles, application processes, requirements for new and existing medicines, variations, renewals, labeling, and administrative measures. The directive aims to ensure the quality, safety, and efficacy of medicines available in the Ethiopian market and protect public health.

Who's affected

Manufacturers and importers of medicines (chemical, vaccines, and other biological medicines), including local and foreign entities, as well as individuals and entities involved in the distribution and sale of these products within Ethiopia.

Action required

Businesses involved in the pharmaceutical sector must review the directive and ensure their operations, applications, and documentation comply with the outlined requirements for marketing authorization, variations, and renewals.

Key points

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  • The directive consolidates and clarifies the process for obtaining marketing authorization for all types of medicines in Ethiopia.
  • It emphasizes the importance of ensuring medicine quality, safety, and efficacy through rigorous evaluation.
  • Specific procedures are outlined for new medicines, generic medicines, biological products, variations, and renewals.
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    • The directive promotes transparency and accountability in the regulatory process.
    • It introduces mechanisms for expedited review for priority medicines and those addressing unmet medical needs.
    • Provisions for recognizing approvals from stringent regulatory authorities and WHO prequalification are included to streamline the process.
    • Strict measures are in place for handling falsified information and addressing post-market quality and safety concerns.

Requirements

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  • Submission of a complete marketing authorization application dossier according to the Authority's guidelines.
  • Provision of adequate study evidence on product quality, safety, and efficacy.
  • Appointment of a pharmacy professional to oversee the registration process.
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    • Submission of GMP compliance certificates and marketing authorization certificates from the country of origin.
    • Adherence to specific formats and languages (English or Amharic) for application documents.
    • Compliance with regulations for variations, renewals, packaging, and labeling.
    • Submission of detailed information on active pharmaceutical ingredients, excipients, manufacturing processes, and quality control.
    • Conducting and submitting pre-clinical and clinical study reports (as applicable).
    • Compliance with methods of analysis and reference standards.
    • Obtaining necessary approvals and licenses before placing products on the market.

Rights and permissions

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  • Right to apply for marketing authorization for medicines.
  • Right to request for renewal of marketing authorization.
  • Right to apply for variations to registered products.
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    • Right to receive market authorization certificates upon successful evaluation.
    • Right to appeal administrative decisions related to marketing authorization.

Restrictions

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  • No marketing authorization application will be accepted without prior consent from the marketing authorization holder if an agency agreement is involved.
  • The trade name of a product cannot be identical to the first or last three letters of an already registered product's trade name.
  • Products must be placed on the market only after obtaining marketing authorization.
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    • Marketing authorization holders cannot make changes to approved labeling, packaging, or conditions without prior notification and approval.
    • Variations classified as 'major' or 'minor requiring prior approval' cannot be implemented without explicit approval from the Authority.
    • Applications found to contain falsified or fabricated information will be rejected, and other applications may be suspended.
    • Marketing authorization can be suspended or revoked if quality, safety, or efficacy issues are identified.

Penalties

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  • Rejection of marketing license applications.
  • Suspension of applications and existing marketing authorizations.
  • Revocation of marketing authorization certificates.
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    • Legal consequences for submitting falsified or fabricated information.
    • Payment of penalties for late renewal of marketing authorization certificates.
    • Requirement to re-apply as a new applicant if authorization is cancelled due to non-renewal.

Objectives

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  • To ensure the quality, safety, and efficacy of medicines in the Ethiopian market.
  • To protect and promote public health by regulating the marketing authorization of medicines.
  • To provide a transparent and accountable system for medicine marketing authorization.
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    • To facilitate access to essential medicines and medicines for unmet medical needs.

Organizations

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  • Ethiopian Food and Drug Authority (EFDA)

Legal references

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  • Food and Medicine Administration Proclamation No. 1112/2019, Article 71(2)
  • Administrative action and complaint submission directive
Original sourcehttps://justice.gov.et/en/directives/medicine-marketing-authorization-directive-no-963-2023/
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