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Small-Scale Medicine Establishment Directive No. 339/2020

Ethiopian Food and Drug Authority339/2020

Summary

This directive establishes regulations for small-scale medicine establishments to ensure products meet safety, quality, and efficacy standards. It outlines requirements for premises, personnel, production, quality control, and administrative measures for non-compliance.

Who's affected

Businesses involved in the small-scale manufacturing of medicines, including sanitary items, cosmetics, antiseptics, and medical supplies.

Action required

Small-scale medicine manufacturers must apply for and obtain a certificate of competence from the Ethiopian Food, Medicine and Healthcare Administration and Control Authority by fulfilling specified requirements for premises, professionals, and equipment.

Key points

8
  • Mandatory certificate of competence for small-scale medicine establishments.
  • Detailed requirements for premises, including location, design, and specific areas.
  • Personnel qualifications and responsibilities, including technical manager and quality control staff.
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    • Emphasis on Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
    • Procedures for application, inspection, and renewal of certificates.
    • Provisions for suspension and revocation of licenses for non-compliance.
    • Requirement for clear labeling and appropriate packaging of products.
    • Procedures for waste disposal and handling of administrative measures.

Requirements

10
  • Obtain a Certificate of Competence from the Authority.
  • Fulfill requirements for premises (location, design, construction, maintenance, specific rooms, utilities).
  • Fulfill requirements for professionals (adequate number, qualifications, specific roles like Technical Manager and Quality Control personnel).
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    • Fulfill requirements for equipment (location, design, construction, maintenance, material, calibration).
    • Adhere to specific practices including quality control and assurance, sanitation, labeling, packaging, storage, transportation, and record-keeping.
    • Comply with pre-approval and post-approval inspections.
    • Notify the Authority of any change in premises address, ownership, or trade name.
    • Maintain premises, professionals, and practices in compliance even after obtaining the certificate.
    • Dispose of pharmaceutical waste according to relevant directives.
    • Pay applicable service fees to the Authority.

Rights and permissions

3
  • Right to appeal administrative measures taken by the Authority.
  • Right to re-inspection free of charge after corrective actions.
  • Right to lodge a complaint within 30 days of an administrative measure.

Restrictions

6
  • Manufacturers must not engage in activities violating the directive or other applicable laws.
  • Manufacturers must not manufacture products other than those permitted by the Authority.
  • Manufacturers must obtain prior notification and approval from the Authority for any change in location, trade name, or ownership.
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    • Manufacturers must not operate without a valid certificate of competence.
    • Manufacturers must comply with specific hygiene and personnel conduct rules.
    • Manufacturers must ensure proper labeling and packaging of products.

Penalties

3
  • Suspension of certificate of competence for violations such as allowing unlicensed practice, failing inspections, falsifying information, manufacturing without authorized personnel, or unauthorized changes.
  • Revocation of certificate of competence for serious violations, manufacturing unpermitted products, failure to renew permits, or obtaining the certificate through false information or illegal means.
  • Subject to administrative measures as per the Directive on Administrative Measure Taking and Complaint Handling Procedure.

Objectives

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  • To ensure products manufactured in small scale medicine establishments meet required safety, quality, and efficacy standards.
  • To set and define minimum requirements for practices, premises, professionals, and products of small scale medicine establishments.
  • To ensure adherence to current Good Manufacturing Practice and Good Laboratory Practice.

Organizations

1
  • Ethiopian Food, Medicine and Healthcare Administration and Control Authority

Legal references

3
  • Food, Medicine and Healthcare Administration and Control Proclamation No. 661/2009, Article 55(3)
  • Directive on Administrative Measure Taking and Complaint Handling Procedure
  • Health care waste management Directive No.16
Original sourcehttps://justice.gov.et/en/directives/small-scale-medicine-establishment-directive-no-339-2020/
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