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Traditional Medicinal Products Manufacturing Certificate of Competence and Market Authorization Directive No. 957/2023

Jan 9, 2023Ethiopian Food and Drug Authority957/2015

Summary

This directive establishes requirements for the manufacturing, registration, and market authorization of traditional medicinal products in Ethiopia. It outlines procedures for obtaining certificates of competence, applying for market authorization, conducting clinical trials, and post-approval monitoring. The directive aims to ensure the quality, safety, and efficacy of traditional medicines, protect public health, and regulate their production and distribution.

Who's affected

Manufacturers and distributors of traditional medicinal products.

Action required

Manufacturers must ensure their facilities and products comply with the Good Manufacturing Practice (GMP) standards outlined in the directive and apply for the necessary certifications and market authorizations.

Key points

Establishes manufacturing, registration, and market authorization requirements for traditional medicinal products.
Mandates Good Manufacturing Practice (GMP) compliance.
Requires manufacturers to obtain a Certificate of Competence and market authorization.

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Details procedures for applications, inspections, and quality control.
Outlines requirements for clinical trials, product recalls, and post-approval monitoring.
Prohibits advertising, promotion, and sponsorship of traditional medicinal products.
Specifies administrative measures, including warnings, suspension, and revocation of licenses for non-compliance.
Sets the effective date as the date of registration by the Ministry of Justice and upload on its website.

Requirements

Manufacturers must obtain a Certificate of Competence from the Authority.
Traditional medicinal products must be manufactured following Good Manufacturing Practice (GMP).
New manufacturing facilities must meet the directive's requirements before construction.

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Applicants for a Certificate of Competence must submit specific documents, including proof of fee payment, factory address, layout and design, waste management information, material and personnel flow, and water system design.
Manufacturing premises must be suitable for the intended operation, protected from contamination, and have adequate lighting, temperature, humidity, and ventilation control.
Manufacturing and storage rooms must be kept clean, disinfected, and free from pests.
A clearly visible signboard indicating the facility's purpose must be at the entrance.
The layout of premises must minimize the risk of errors and facilitate effective cleaning.
Water systems for manufacturing must ensure water of appropriate quality and prevent contamination.
Materials used for cleaning, lubrication, and pest control must not come into direct contact with products and should minimize health risks.
All materials and products must be stored under appropriate conditions, with proper stock rotation.
A robust stock management system must be in place.
Manufacturing documentation must be designed, prepared, reviewed, signed, and dated by responsible persons.
Documents must have clear and unambiguous content, regularly reviewed and updated.
Data entries in documents must be legible copies of the original information.
The professional in charge of traditional medicinal product manufacturing must be an experienced pharmacist or chemist with at least two years of experience.
Manufacturers must have heads for the production and quality inspection departments.
All employees must wear appropriate dust-free work safety clothing.
Written procedures must be in place for handling product defect complaints, including potential recalls.
Special attention must be given to complaints possibly caused by counterfeiting or falsification.
Any complaint concerning a product defect must be recorded and thoroughly investigated.
Manufacturers must immediately inform the authority of potential faulty manufacture, product deterioration, or serious quality problems.
A system must be in place to recall defective or suspected defective traditional medicinal products from the market promptly and effectively.
The authorized person is responsible for the execution and coordination of recalls.
Written procedures for recall activities must be established, regularly reviewed, and updated.
Recall operations must be capable of being initiated promptly down to the required level in the distribution chain.
The authority must be informed of any intention to recall a product.
Distribution records must contain sufficient information to permit an effective recall.
The progress of recall processes must be monitored and recorded.
Applications for product registration must be submitted with a completed form, technical documents, and administrative requirements.
Product registration applications must not resemble previously registered products in spelling, pronunciation, or packaging.
Submitted samples must conform to existing labeling regulations.
Scientific and/or botanical names, plant parts used, and quantities of active ingredients must be submitted.
The list of recipients and their quantities used in the preparation must be submitted.
Indications for which products are presented for registration must be unambiguously stated.
Brand names shall not be identical to registered products in Ethiopia.
The Authority may request additional information for decision-making on applications.
A certificate of registration shall be issued upon satisfaction of requirements.
Product registration is valid for four years and renewable.
Information supplied to the Authority shall not be disclosed without written consent.
Applications for variation of registration must be made to the Authority prior to re-registration and be supported by documentation.
Applications for re-registration must be made four months before expiration and include confirmation of no changes in formulation or composition if applicable.
Re-registration requirements include a valid manufacturing permit, GMP certificate, and proof of no changes.
Product packaging and labeling must be original or computer-ready, color-printed, and include specific content details.
Ethno botanical and Toxicological research data reports, pre-clinical trial, and clinical trial data must be submitted from a recognized national research institute.
Quality testing results, including physical identification, microbial testing, heavy metals, pesticide residue, and foreign matter testing, must be conducted according to specified standards.
Market authorization is granted after satisfactory laboratory reports and confirmation by the National Expert Committee on Traditional Medicines.
A fee is required for a registration certificate per product.
The Authority verifies application information and manufacturing site inspection results before granting or renewing licenses.
Clinical trials require authorization following a decision by a technical advisory committee.
Sponsors must be legally recognized and undertake clinical trials.
A maximum of 90 days is allowed for the notification of approval, adjournment, or rejection of clinical trial applications; otherwise, authorization is deemed granted.
Sponsors and chief investigators must ensure clinical trials comply with good practices guidelines.
Sponsors must inform the Authority of any unexpected events during trials.
Mid-term and final reports of trial results must be submitted to the Authority.
Duly mandated clinical trials may be inspected by the Authority.
Ethical matters for clinical and non-clinical trials must adhere to ethical regulations.
Granting of clinical trial authorization is subject to payment of an application fee.
The Authority monitors and evaluates manufacturing and storage premises and approved professionals post-approval.
Incidental inspections may be performed, and premises/professionals are inspected as required for certificate renewal.
Any change in premises location, trade name, ownership, or registered details requires prior notification and approval by the Authority.
Traditional medicinal products must be stored according to label instructions, separately from contaminants, and with applicable safety requirements observed during storage, handling, and transportation.
Deteriorated, expired, and damaged products must be stored separately until disposal.
The Authority may take administrative measures based on the severity of violations.
Administrative measures can be taken if information provided for market authorization differs from actual packaging, labeling, or disclosure.
The Authority may seize and dispose of non-complying traditional medicinal products.
Written warning letters may be issued for violations not leading to suspension or cancellation of certificates.
Failure to take corrective action after a warning letter may result in further administrative measures.
License suspension (one month to one year) may occur for reasons including allowing unlicensed professionals, obstructing inspections, providing false information, making unapproved changes, or dual employment.
License revocation (at least two years) may occur for serious violations, manufacturing unpermitted products, failure to renew permits, or obtaining certificates fraudulently.
Revoked, suspended, or un-renewed certificates of competence must be returned to the Authority.
Certificates of competence must be returned if the Authority deems the service dangerous to society.
Advertising, promotion, and sponsorship of registered traditional medicinal products are prohibited.
Communication through broadcasts, social media, distribution of flyers, providing free samples, price discounting, and associating product names with conventional medicines are prohibited promotional acts.
The Authority may issue required regulatory documents to exporters based on destination country requirements.
Service fees are applicable for regulatory services provided under this directive.
All concerned parties have a duty to cooperate with the Authority to effectively execute responsibilities under this directive.
Any directive, circular, or customary practice inconsistent with this directive is inapplicable concerning matters covered herein.

Rights and permissions

Manufacturers have the right to be informed of deficiencies in their premises and given an opportunity to correct them.
Applicants receive an official letter on the status of their application within five working days.
Approved applicants may procure raw materials from approved suppliers before starting manufacturing.

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The Authority shall issue approval to conduct manufacturing activity when requirements are fulfilled.
The Authority may issue required regulatory documents to exporters.
Individuals receiving regulatory services may be required to pay applicable service fees.
All concerned parties have the duty to cooperate to assist appropriate organs.
The Authority shall issue approval to conduct manufacturing activity when requirements are fulfilled.

Restrictions

Manufacturers must obtain a Certificate of Competence.
Products must adhere to Good Manufacturing Practice (GMP).
New facilities require pre-approval for construction.

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Specific documents are required for applications.
Premises must meet specific standards.
Materials must not directly contact products.
Stock rotation (FIFO/FEFO) is required.
Documentation must be accurate and updated.
Professionals in charge must meet qualification criteria.
Employees must wear safety clothing.
Product defect complaints require specific procedures.
Product recalls must be effective and prompt.
Product registration applications must be unique and meet labeling regulations.
Scientific and botanical names, plant parts, and ingredient quantities must be declared.
Indications for use must be clearly stated.
Brand names cannot be identical to existing registered products.
Information supplied to the Authority is confidential unless authorized.
Variations in product registration require notification and potential re-testing.
Re-registration applications have specific timelines and requirements.
Product packaging and labeling must comply with regulations.
Ethno botanical and Toxicological data, pre-clinical and clinical trial data must be submitted.
Quality testing must meet international standards.
Clinical trials require authorization and adherence to ethical guidelines.
Post-approval inspections are conducted.
Changes to premises require prior approval.
Products must be stored and transported under specific conditions.
Deteriorated/expired products must be segregated.
Administrative measures, including warnings, suspension, and revocation, can be imposed for non-compliance.
Advertising, promotion, and sponsorship of traditional medicinal products are prohibited.
Specific acts related to advertising and promotion are prohibited.
Export of products depends on destination country requirements and Authority approval.

Penalties

Written warning letters for minor violations.
Suspension of Certificate of Competence for one month to one year for specific violations.
Revocation of Certificate of Competence for at least two years for serious violations.

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Seizure and disposal of non-complying products.
Administrative measures depending on the severity of the violation.

Objectives

To ensure the quality, safety, and efficacy of traditional medicinal products.
To protect and promote public health.
To regulate the manufacturing and market authorization of traditional medicinal products.

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To establish clear guidelines for pre-clinical research, clinical trials, and post-approval monitoring.
To ensure traditional medicinal products meet Good Manufacturing Practice (GMP) requirements.

Organizations

Ethiopian Food and Drug Authority (EFDA)
Ministry of Justice

Legal references

Food and Medicine Administration Proclamation No. 1112/2019, Article 71(2)
Council of Ministers’ Service Fee Regulation No. 370/2008
Directive on Administrative Measure Taking and Complaint Handling

Original sourcehttps://justice.gov.et/en/directives/traditional-medicinal-products-manufacturing-certificate-of-competence-and-market-authorization-directive-no-957-2023/

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