Ethiopia Pharmaceutical Licensing

This record discusses retail, wholesale and local manufacturing of human medicines in Ethiopia. Proclamation No. 1112/2019 defines as establishments the premises involved in manufacturing, export, import, wholesale, retail and repackaging, among other activities, and defines a Certificate of Competence as authorisation to conduct these regulated activities. An establishment Certificate of Competence, product marketing authorisation, import/export authorisation, controlled substances authorisation and personal professional registration are not the same authorisation.

The Proclamation allocates responsibilities between the federal and regional levels “as applicable”: the EFDA is responsible for federal-level matters such as imports, exports, and inter-regional manufacturing or wholesale, while regional health regulatory authorities implement the Proclamation at regional level. The manufacturing Directive allows structures such as sole proprietorships, partnerships and limited companies/legal entities recognised under the investment law or by the competent authority. However, this review did not verify the full foreign investment, beneficial ownership, capital and company law requirements for retail/wholesale or manufacturing businesses, so no foreign ownership restriction or exemption should be inferred.

— Retail: establishment certificate, applicable local/regional procedures, personnel and GSP/dispensing requirements.

— Wholesale: establishment certificate, GSP/GDP, supply chain and recall controls.

— Manufacturing: EFDA Certificate of Competence, GMP, product marketing authorisation and applicable cross-border permits.

The EFDA website states that it is the national medicines regulatory authority under the Ministry of Health, established under Proclamation No. 1263/2021, with powers under Regulation No. 531/2023. Its responsibilities include regulation of product registration/marketing authorisation, Certificates of Competence, import permits, inspections, recalls and post-market surveillance, as well as the manufacture, import and export, wholesale, dispensing, recording and disposal of narcotic drugs, psychotropic substances and precursors.

A regional health regulatory authority is a regional government body authorised to implement the Proclamation and its implementing rules at regional level. The EFDA may also inspect premises within regions, including retail premises, set federal-regional coordination standards and support regional regulatory authorities. Therefore, EFDA inspection of retail premises does not mean that every retail certificate is issued directly by the EFDA.

— EFDA: federal pharmaceutical regulation, inter-regional manufacturing/wholesale, imports/exports, product and risk regulation.

— Regional health regulatory authorities: handle regional establishment licensing and enforcement, as applicable.

— Professional regulatory authorities: personal licensing/registration of pharmacists, druggists and pharmacy technicians.

Before conducting pharmaceutical trade, retail pharmaceutical establishments must be registered and obtain a Certificate of Competence, as applicable. The EFDA 2025 Inspection Manual classifies pharmacies and drug shops as community pharmacies; pre-licensing inspection verifies basic infrastructure, premises, documents, personnel and necessary equipment, with continued inspections after certification. The products that pharmacies and drug shops may sell, the responsible persons and specific facility requirements may differ; follow the current category and checklist for the proposed location.

The community pharmacy items in the Inspection Manual include the technical manager’s registration/licence, arrangements for a qualified deputy, display of the current Certificate of Competence in a place visible to the public, and storage and dispensing equipment, temperature and humidity records, cold-chain equipment, source documents and a secure cabinet for applicable controlled drugs. The Manual is a national inspection standard; it does not replace the complete application documents or fee requirements set by the regional authority for a specific retail tier.

— First confirm the proposed location, pharmacy/drug shop category and actual receiving authority.

— Staff registered and competent health professionals and prepare their personal licence documents.

— Open only after completing the pre-licensing inspection, and maintain certificate display, storage, records and cooperation with recalls.

Wholesale is a pharmaceutical establishment activity under Proclamation No. 1112/2019 and requires a Certificate of Competence issued as applicable. The EFDA powers page expressly states that it issues Certificates of Competence or special regulatory permits to wholesalers engaged in inter-regional activities. The EFDA website also states that i-License accepts applications for new wholesale facility licences, renewals and amendments. The actual licensing authority for business confined to a single region should be confirmed with the regional regulatory authority for the proposed location.

Wholesalers must comply with applicable GSP/GDP requirements covering procurement, receipt, storage, transportation, documentation and traceability. The EFDA 2024 Guideline on Storage, Distribution and Recall requires wholesalers to establish their own recall SOPs and cooperate with the EFDA, manufacturers and importers in implementing recalls; the 2025 Inspection Manual lists new applications, renewals, extensions, relocation, premises alterations and changes of technical manager as matters that may trigger an inspection.

— Confirm whether the business operates across regions and, accordingly, determine whether the EFDA or a regional application route applies.

— Establish supplier/customer verification, temperature and humidity controls, quarantine, returns, transportation, complaints and recall documentation.

— For imported medicines, also hold a valid EFDA import permit and verify product registration or special import authorisation.

Directive No. 1054/2025 on the Control of Medicine Manufacturing Facilities applies to local manufacturers of medicines for human use. Every manufacturer must obtain an EFDA Certificate of Competence before commencing production. Applications are submitted through the electronic regulatory information system, and the EFDA conducts a pre-approval inspection. If deficiencies are identified, the applicant must submit CAPA; the EFDA may withhold the certificate if corrective actions are not completed satisfactorily.

The site and design of a manufacturing plant must comply with GMP. Requirements for premises, materials, equipment, personnel, production, QC/laboratory, qualification/validation, water and HVAC are governed by the national GMP guideline or WHO GMP technical reports. A factory certificate does not automatically authorise a product to be placed on the market: the product must also be separately registered and obtain marketing authorisation.

— First define the dosage forms, production lines, testing, packaging and outsourced activities within the scope of the licence.

— Submit the electronic application, service fee, key personnel details, and pre-approval inspection/CAPA materials.

— After establishment, maintain GMP, self-inspection, complaints, batch traceability and recalls; apply separately for marketing authorisation for each product.

Medicine establishments must ensure that the health professionals they employ are registered and competent. The notice defines pharmacy professionals as a pharmacist, druggist or pharmacy technician licensed by the relevant health professional regulatory authority. Therefore, an establishment’s Certificate of Competence does not automatically confer individual professional practice qualifications on its owners or employees.

Manufacturing applications have more specific requirements for key personnel: management positions in technical, production, QA and QC, as well as sufficient qualified personnel. Key positions must be full-time, and the heads of production and quality control must be independent of each other. Retail and wholesale businesses should also maintain records of duties, valid professional licences, training and cover arrangements; however, this review does not extend the manufacturing-sector education and experience table to all retail or wholesale positions.

— Individuals: verify professional registration, licensing and role-specific competence.

— Retail: assign a technical manager, eligible deputy and dispensing personnel appropriate to the category of premises.

— Manufacturing: implement the key technical, production, QA and QC positions and independence requirements under Directive No. 1054/2025.

The core requirement for retail and wholesale premises is suitability for the business applied for and the ability to pass pre-licensing and ongoing inspections. The EFDA Guideline on Storage, Distribution and Recall applies to manufacturers, importers, wholesalers, retail outlets and hospital pharmacies. It requires GSP/GDP to be implemented according to the activities undertaken, with appropriate personnel, a quality management system, and suitable storage and transportation conditions. Retail inspections also examine cold-chain management, temperature and humidity, equipment, cleanliness, records and the secure storage of controlled products.

Manufacturing premises must be located away from sources of contamination that could compromise the safety, quality or efficacy of medicines; in principle, they should be located in an industrial park. For sites outside an industrial park, the relevant federal or regional authority, in consultation with the EFDA, evaluates suitability based on a technical proposal/study. The publicly available materials do not specify a national minimum floor area that can safely be applied to retail and wholesale premises; no square-metre threshold should be invented.

— Retail: storage, dispensing, cold-chain management, records and secure storage are subject to on-site inspection.

— Wholesale: the layout should support receipt, quarantine, storage, dispatch, traceability and recalls.

— Manufacturing: provide facilities, equipment, utilities, QC and validation systems in accordance with GMP.

The starting point for a medicine establishment is to determine the business activity and jurisdiction: a retail establishment should first confirm the application route with the regional/city health regulatory authority where it plans to operate; cross-regional wholesale, manufacturing and import/export activities follow the EFDA route. Directive No. 1054/2025 on manufacturing expressly requires applications and necessary documents to be submitted through the electronic regulatory information system, applicable service fees to be paid, key personnel to be in place and a pre-approval inspection to be conducted. The EFDA website states that i-License supports applications for Certificates of Competence for importers, exporters, wholesalers and manufacturers.

The verified core materials for manufacturing applications include the electronic application and attachments, proof of payment, sufficient qualified personnel, key technical/production/QA/QC personnel, the pre-approval inspection report and applicable CAPA assessment, and the technical manager’s photograph and TIN. For retail and wholesale, the complete document list should be confirmed against the current list of the authority actually receiving the application; however, statutory entity and premises documents, personnel licences, quality documents, storage/temperature-control and supply-chain/recall documents can be prepared in advance.

— First separate applications for the establishment, personnel, premises, products, import/export and controlled substances.

— Manufacturing: electronic submission, fee payment, key personnel, pre-approval inspection and corrective actions.

— Retail/wholesale: before submission, obtain from the actual licensing authority the current categories, document list, inspection requirements and fee requirements.

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Certificates of Competence for manufacturing are renewed annually. Directive No. 1054/2025 requires manufacturers to apply for renewal starting 3 months before the certificate expires, submit a valid GMP certificate and confirm payment of the required service fee; failure to renew in accordance with the directive may be treated as cancellation. The directive allows an extension of up to 6 months with a supporting letter where the EFDA confirms force majeure. The EFDA conducts a GMP inspection of manufacturers at least once every 3 years.

This review did not identify a current, unified official fee schedule or guaranteed approval timeline covering all retail, wholesale and manufacturing licence types. The manufacturing directive refers only to payment of the “applicable service fee” and does not specify a uniform amount in the materials accessible for this review. Medicine product registrations are valid for 5 years, but this is the validity period of product marketing authorisation, not of an establishment certificate.

— Manufacturing: annual renewal; prepare the GMP certificate and fee confirmation in accordance with the rules before expiry.

— Retail/wholesale: confirm fees, renewal dates and inspection schedules with the actual licensing authority.

— Products: marketing authorisation is valid for 5 years; apply separately for re-registration.

The entire supply chain must maintain applicable GSP/GDP. The EFDA guideline requires sufficient trained personnel, a quality management system, written training records, protection of product safety and integrity, and manufacturers, importers and wholesalers to establish recall SOPs, with retail outlets cooperating in recalls. Routine controls should cover storage conditions, supply-chain documentation, complaints, quarantine, returns, traceability and regulatory communications.

Manufacturers must also maintain GMP. The 2025 GMP Guideline requires validation of critical processes and major changes, batch traceability records, investigation of complaints/quality defects, a recall system and self-inspection/quality audits. Post-approval inspections under the manufacturing directive assess changes in operations, maintenance of the quality system, recent recalls, complaints and CAPA; the EFDA may increase inspection frequency based on risk.

— Retail/wholesale: GSP/GDP, personnel training, temperature/humidity and cold-chain controls, source and destination records, and recall cooperation.

— Manufacturing: GMP, validation, batch records, deviations/complaints, recalls and self-inspection.

— All establishments: maintain current certificates, personnel records, inspection and corrective-action documents, and remain subject to ongoing regulatory oversight.

Notice No. 1112/2019 prohibits the transfer of a Certificate of Competence for a medicine/medical-device establishment to a third party in any manner. Accordingly, a share sale, asset transaction, lease assignment or replacement of the person in charge must not be described as automatically transferring the existing certificate. For manufacturers, Directive No. 1054/2025 expressly requires prior EFDA authorisation for changes such as address, ownership, key personnel, product/service categories, room alterations, restructuring or partitioning; applications must be made through the electronic regulatory information system.

The EFDA 2025 Inspection Manual lists relocation, premises alterations and a change of technical manager as circumstances that may trigger a routine inspection. For retail and single-region wholesale, the official materials reviewed do not fully specify, for every type of ownership/control change, whether an amended certificate, re-inspection or new application is required. Before a transaction, obtain written confirmation from the actual licensing authority, and make the establishment certificate, product authorisations, personnel licences and inventory compliance separate closing conditions.

— Manufacturing: before implementation, apply for EFDA approval of changes to address, ownership, key personnel, product/service scope and structural alterations.

— Retail/wholesale: confirm the procedure with the actual licensing authority before changing address, altering premises, changing the technical manager or changing ownership.

— Transactions: do not assume licences transfer automatically; separately verify the status of the establishment, products, personnel, inventory and controlled substances.

Medicine marketing authorisation is separate from an establishment certificate. The EFDA Guideline for Registration of Medicines requires product dossiers to be submitted through eRIS; registrations for registered medicines are valid for 5 years, and an application for re-registration should be submitted before expiry. Post-registration changes follow a separate post-approval variation procedure. The Traceability Master Data Guideline further specifies that local manufacturers, importers and wholesalers must hold a Certificate of Competence, while medicines must be registered or have import authorisation.

Commercially imported medicines must be registered with the EFDA or have special import authorisation before customs clearance, and the importing entity must also hold a valid EFDA import permit. Goods enter through designated ports, documents are submitted via the electronic single window, and shipments are subject to risk-based inspection. Special importation is limited to specified cases such as shortages, emergencies, research and clinical trials; it cannot replace routine market authorisation. The EFDA issues Certificates of Competence/special permits for exporters; the routine export procedure was not fully extracted in this review, so obtain the EFDA’s written requirements in advance. Narcotic drugs, psychotropic substances and precursors are separately regulated by the EFDA.

— Products: verify marketing authorisation, registration validity, labelling and post-approval changes for each product.

— Imports: verify the importer’s certificate, product registration/special authorisation, shipment-specific documents, designated port and customs clearance.

— Exports and controlled substances: obtain the applicable case-specific requirements/authorisation from the EFDA before shipment or conducting business.