Chapter 1 - Governance, Legal, and

Regulatory Framework

May 2025
Arbaminch, Ethiopia
 Chapter Description
• This chapter provides a foundational overview of Ethiopia’s health and
pharmaceutical system.
•It addresses key concepts such as
– Structure, legal basis, and regulatory governance
– Introduces roles and responsibilities of institutions
– Explains national standards
– Describes the procedures for licensing and inspection.
– Defines essential regulatory terms
 Primary Objective
• The participants will be able to:

– Describe the structure and functions of Ethiopia’s health and

pharmaceutical system, the legal and regulatory framework.

– Describe the requirements of community pharmacies.

– Explore the licensing and inspection processes.

 Enabling Objectives

• By the end of this chapter, participants will be able to:

– Describe the structures, functions and tiers of Ethiopia’s health system and
pharmaceutical systems
– Explain the legal foundations of regulation, and the structure of regulatory bodies

– Define key terms and concepts relevant to pharmacy and drug shop operations

– Describe the national minimum pharmacy and drug shop standards

– interpret regulatory terminologies in the context of compliance with the standards

– Describe the procedures for licensing, inspection and regulatory enforcement

 Chapter Outline
 Overview of Ethiopia’s Health and Pharmaceutical System
 Legal Basis for Regulation
 National Pharmacy and Drug Shop Standards
 Scope and Definitions of Key Terms
 Regulatory Terminologies (“Shall”, “May”, “Should”) and Interpretation
 Licensing and Inspection Processes
 Chapter Summary
Overview of Ethiopia’s Health and Pharmaceutical System
Activity 1.1: Reflection Questions
 Reflect your experience and discuss the following questions
 How would you define a system, a health system, and a pharmaceutical system in
your own words?
 What is the main role of a health system in serving the population?
 What are the key building blocks that make a health system function effectively?
 What are the main components of a well-functioning pharmaceutical system?
 How do the health system & pharmaceutical system work together in practice?
Time: 10 minutes
 What is a Health System?
• Health system: the collective organization of people, institutions,
infrastructure, and process whose primary purpose is to deliver
healthcare services to meet the health needs of a population.
• It includes prevention, diagnosis, treatment, and rehabilitation services

• A health system consist of all the people and actions primarily aimed at
improving health
 Core components of Health System
• Core Components: Six interrelated • Characteristics of Health Systems
– Equity
core functions/building blocks essential Note: A health system – Quality
for well functioning health system consists of all the people and – Access
actions primarily aimed at
improving health. Each part of – Efficiency
the system is interdependent – Responsiveness
and must be strengthened – Governance
holistically to ensure – Integration
efficiency, quality, and – Comprehensiveness
resilience. – Sustainability
– Resilience
– Community participation
 Health System Strengthening
• Refers to strategic efforts aimed at improving the performance, resilience

and effectiveness of a health system.

• Consistently and efficiently deliver quality services, reach all populations, &

adapt to changing health needs.

• It encompasses workforce development, infrastructure improvement, health

financing reform, digitalization, and community engagement

 Health System Strengthening
•Why strengthen health systems?

– To improve health outcomes across the population.

– To achieve Universal Health Coverage (UHC) by providing essential

services without financial hardship.
– To build resilience against shocks such as pandemics or disasters.
 Health System Strengthening
•Examples of health system strengthening initiatives:

– Expanding healthcare infrastructure and facilities.

– Training and deploying more healthcare professionals.

– Strengthening supply chains for essential medicines.

– Enhancing digital health and health information systems.

– Promoting policy reforms and strategic health planning.

 Ethiopia Health System
Activity 1.1.1 – Reflection Discussion
Discuss and answer the following:
• What are the three main pillars of Ethiopia’s health system, and what
is the role of each?
• Briefly describe the three-tier healthcare delivery structure and
give one example of a service provided at each level.
Time: 5 minutes
 Pillars of the Health System
• Our health system is grounded in a three-pillar structure, as
defined in the national health policy
1. Service Providers - Facilities and professionals delivering health services.
2. Health Regulators - Institutions like EFDA ensuring safety, quality, and
compliance.
3. Service Purchasers - Bodies managing health financing and purchasing
services (e.g., insurance schemes).
Ethiopia’s Health Tier System

• Three Tier System

• Based on level of care
 What is Pharmaceutical System?
• Pharmaceutical system is defined as all structure, people,
resources, policies and processes, and their interactions within
the broader health system that aim to ensure equitable and
timely access to safe, effective, quality pharmaceutical
products and related services that promote their appropriate
and cost-effective use to improve health outcomes.
• It is a sub-system of the health system
• Figure 2: Components of Pharmaceutical Systems taken from
Includes both private and public sector actors Medicines, Technologies, and Pharmaceutical Services (MTaPS)
Program Brief report, February 2023.
• It has many core components (Figure 2)
 What is Pharmaceutical System?
 Characteristics of a strong pharmaceutical system:
 Clear leadership and accountable governance
 Stable, well-functioning and integrated regulatory frameworks
 Reliable financing mechanisms for medicines and services
 Competent pharmaceutical workforce and institutions
 Accurate product and patient information systems
 Consistent availability of quality-assured medical products

 Services that promote rational use and safeguard patient safety

Overview of Legal Basis for Regulation
Activity 1.2. – Group Brainstorm – Regulatory Foundation
In small groups, reflect on the mandates of EFDA and regional regulatory bodies.
Discuss the following:
• What is the legal basis for developing and enforcing community pharmacy
standards in Ethiopia?
• Who is responsible for enforcing these standards at national and regional levels?
• Who develops and owns the community pharmacy standards?
Time: 10 minutes
 Overview of Legal Basis for Regulation
• Legal foundation for regulating pharmacy practices in Ethiopia is grounded in
national proclamations, regulations, directives and standards.
• Legal instruments provide the authority to develop, implement, and enforce
standards for pharmacies and drug shops
– Food and Medicine Administration Proclamation No. 1112/2019

– Food, Medicine, and Health Care Administration and Control Proclamation No. 661/2009

– Regulation No. 531/2023

– Regional level laws

National Pharmacy and Drug Shop Standards
Activity 1.3 – Group Discussion

In groups, reflect on your knowledge and practice experiences.

Discuss the following:
• What are the levels or classifications of community pharmacies in Ethiopia?
• How do community pharmacies differ from hospital pharmacies in terms of
purpose and regulation?
• What types of community pharmacy outlets exist across the country?
Time: 5 minutes
 Terms and Definitions
• Pharmacy: a private, government or non-government owned community pharmacy led by a registered
and licensed pharmacist to provide pharmaceutical care and dispense medicines to consumers.
• Community pharmacy: a licensed pharmacies and drug shops that provide pharmacy services where
pharmacy professionals directly in contact with patients and dispense medicines with monitoring drug
therapy. Dispensing of medicine may be either on prescription order or over-the-counter.
• Self-contained: containing in oneself all necessary service rooms and that do not connect with other
service room using doors and windows. This does not include common stairs.
• Prescription: a paper or electronic order for medicine that meets requirements set by the authority, and
written and signed by a duly licensed medical professional and issued to patients to collect medications.
 National Pharmacy and Drug Shop Standards
• The Ethiopian standards for pharmacies and drug shops are formally
designated as CES 363:2024 and CES 362:2024, respectively.
• These Compulsory Ethiopian Standards (CES) were developed under the
coordination of the IES with technical input from EFDA and the TC 88 and
endorsed by the National Standards Council.
• The CES 363 and CES 362 represent national requirements for the establishment,
operation, and management of community pharmacies and drug shops.
 National Pharmacy and Drug Shop Standards
• Compulsory Standards: requirements that are legally • Voluntary Standards: recommendations that are not
required, meaning organizations must adhere to them to legally binding
comply with. • Key Features of Voluntary Standards:

• Key Features of Compulsory Standards: – Non-legally Binding: not enforced by law. Companies can choose
whether or not to comply.
 Legally Enforceable: Required by law, and businesses shall
– Market-driven: Compliance with voluntary standards can enhance a
comply with them.
company’s reputation, competitiveness, and trust with clients.
 Safety and Health: They often focus on ensuring the safety,
– Industry Best Practices: They often reflect the best practices or ideal
health, and well-being of users.
operational benchmarks within a given industry.
 Regulatory Bodies: usually imposed and enforced by government
– Certification Opportunities: Businesses that comply with
bodies. voluntary standards can often earn certifications or labels,
 Penalties for Non-compliance: Non-compliance leads to fines, which can improve marketability and consumer trust (e.g., ISO
lawsuits, or shutdowns. certifications).
 National Pharmacy and Drug Shop Standards
SN Name of the standards Designation • Anyone can propose or initiate standards

1 Pharmacy - requirements CES 363:2024 • Institute of Ethiopian Standards issue standards

• TC 88 and endorsed by the National Standards

2 Drug Shop - requirements CES 362:2024
Council
3 Community pharmacy certification Issued 2024 • CES 363:2024 for pharmacy and CES 362:2024
scheme for drug shop

• “CES" stands for Compulsory Ethiopian

Standards, and the numbers following "CES"
The implementation of the standards shall be effective
refers to the specific documents that outline the
as of January 09, 2024
requirements.
 National Pharmacy and Drug Shop Standards
• Components of the community pharmacy standards:
– Terms and definitions, such as community pharmacy, self-contained, etc.
– General Requirements
– Specific Requirements – practice, premises, profession and products
– Certification scheme – licensing, admin measure, roles and responsibilities.
 National Pharmacy and Drug Shop Standards
• Importance of the standards

– Protect public health by ensuring the safety, quality, and efficacy of medicines

– Increase consumer trust and confidence in pharmacy services, and professionals

– Enhance uniform and consistent regulatory operations across the country

– Improve regulatory maturity to ensure competition in the regulatory arena

– Minimize unethical and malpractices in pharmacy services

– Promote rational use of medicines, containment of AMR, and minimize the infiltration of SF medicines

– Ensure consistent service delivery in community pharmacies throughout the country

– Guarantee equitable and timely access to medicines and pharmacy services to the public

– Promote professional standards - maintain high professional and ethical standards.

 National Pharmacy and Drug Shop Standards
• Applicable to community pharmacies operating independently of healthcare
institutions, covering government, non-government, and private entities, including:

– Private Pharmacies and drug shops

– Kenema pharmacies

– Red cross pharmacies

– Public Model pharmacies

Note: Hospital-based pharmacies within healthcare facilities are not covered under CES 363 and CES 362
Regulatory Terminology and Interpretation
Activity 1.4 – Reflection
Working in pairs or small groups, select one or two clauses from the pharmacy or drug
shop standards. Reflect on and discuss the following:
• Have you ever encountered challenges interpreting these clauses in practice?
• What were the specific difficulties, and how were they resolved?
• Did different regulatory personnel (e.g., inspectors, supervisors) interpret the same clause
differently?
• What actions did you take to clarify or apply the requirement?
• In what ways has clearer understanding of these clauses improved your regulatory or
professional practice?
Time: 10 minutes
 Regulatory Terminology and Interpretation
• Specific terminologies are used in the standards to convey varying degrees of
obligation or flexibility.
• Terms “shall,” “may,” and “should” are used intentionally within the standards to
guide interpretation, enforcement, and implementation.
• A clear understanding of these terms is essential for consistent regulatory
compliance and decision-making across all levels of pharmacy practice.
 Regulatory Terminology and Interpretation
SN Terms Interpretation Obligation level

1 Shall, shall not Mandatory, must be done, legal High (legal requirement)
binding

2 May, may not Permissible, but not required. Low (permitted, but required)

3 Should, should not Recommended, Advisory, Moderate (preferred, but not

Suggested best practices mandatory)
 Regulatory Terminology and Interpretation
• Stan1: The pharmacy shall not dispense any medicine without prescription. This shall not include over the counter medicines
• Int 1: Interpretation: The pharmacy is legally obligated to not dispense prescription medicines without a valid prescription. But
OTC medicines are not subject to this restriction, and can be dispensed without a prescription.
• Stan 2: The pharmacy may provide compounding services
• Int 2: Interpretation: It is permissible, but not mandatory, for the pharmacy to offer compounding services. The pharmacy
can choose to provide compounding services if it has the necessary resources and qualifications. If the pharmacy offers
compounding services, it shall adhere to the relevant regulations and standards for compounding practices to ensure safety
and compliance.
• Stan 3: The pharmacist should provide a clear explanation of the medication's side effects to the patient.
• Int 3: Interpretation: The pharmacist is encouraged to provide this explanation as it promotes safe use of the medication, but
it’s not strictly required.
 Licensing and Inspection
Activity 1.5: Case Study on Licensing Process
Kidane, a pharmacist with 2.5 years of experience, plans to open “Healthy Roots
Pharmacy” in Bole Sub-city, Addis Ababa. He must follow the required procedures to
obtain a pharmacy license.
Discuss:
• What steps must he follow in the licensing ?
• As an inspector, which key criteria would you evaluate before granting a license?
• Is Kidane eligible to apply for and receive a license?
Time allotted: 10 minutes
 Terms and Definitions
• Certificate of competence: A permit issued for a person to carry out pharmacy services at community pharmacy level
as stated under the appropriate laws and the standards.
 Inspector: Any professional authorized by the authority to perform inspection activities pursuant to standards for
community pharmacies.
 Pharmacy professionals: a pharmacist, druggist or pharmacy technician licensed by an appropriate health
professional regulatory organ.
 Technical manager: a licensed pharmacist or druggist/level IV pharmacy technician who is either an owner or
designated by the owner of a pharmacy to have authority over and be responsible for the operation of the pharmacy
and who is named in the certificate of competence issued by appropriate regulatory body for the pharmacy as the
manager.
 Licensing Process
• Licensing ensures that the outlet meets legal and professional
requirements. The process includes:
– Application Submission Activity 1.5.2: Reading Assignment on
Certification Scheme
– Document Review
Review Sections I, II, and III of the 2024
– Pre-licensing Inspection
Certification Scheme in pairs and
– License Issuance summarize key points on roles, licensure,
and administrative actions.
• Renewal, replacement, etc.
 Inspection Process
• Effective inspection is a cornerstone of pharmaceutical regulation

• Ensuring national standards are met related to premises, personnel, practice,

and products.

• Inspections promote compliance, protect public health, and strengthen the

credibility of pharmaceutical services
 Inspection Process
Activity 1.5.4: Case Study on Inspection Process
Shewit Pharmacy found in Lideta Sub-city is scheduled for a routine inspection by
AAFDA, Lideta Branch. Participants should:
1. Identify key preparatory steps before inspection.
2. Prioritize inspection focus areas.
3. Describe follow-up actions post-inspection.
4. Explain the pharmacy’s expected response to deficiencies.
5. List records to be retained by AAFDA, Lideta Branch.
Time: 10 Minutes
 Inspection Process - Types
• Types of Inspections
– Inspections are generally categorized into two broad types
• Pre-licensing inspections - which assess eligibility before licensure,
• Post-licensing inspections - which ensure ongoing compliance after
licensure
 Inspection Process - Types
• Five specific inspection types are recognized
– Routine inspection
– Concise inspection
– Follow-up inspection
– Special inspection
– Investigative inspection
 Inspection Process
• A standard inspection follows a structured process- consistency, transparency, and
effectiveness
– Planning: Map out facilities, define scope and objectives, review previous reports, prepare necessary tools and checklists,
logistical arrangements and team assignments
– Entry Meeting: Introduces themselves, presents identification, and explains purpose and scope.

– Conducting Inspection: systematic assessment of operations, examine records, interview staff, and observe routine
practices, samples
– Exit Meeting: Summarize initial findings with the pharmacy’s management.

– Report Writing: Report detailing key findings, identified non-compliance, corrective actions with timelines.

– Corrective Actions: Take corrective measures within the specified timeline, follow-up inspections.

– Record Keeping: Inspection-related records must be properly dated, signed, and securely stored
 Inspection Process - areas
• Key area to be inspected - Multiple domains covering
– Personnel: qualifications, training, licensing, and adherence to professional and ethical conduct.
– Premises: evaluation of physical infrastructure such as storage, dispensing and counseling rooms,
sanitation, safety, and surrounding environment.
– Practices: Assessment of procurement sources, storage conditions, dispensing procedures, patient
counseling, and documentation systems.
– Products and Equipment: check the functionality, suitability, and calibration of storage,
compounding, and dispensing equipment and materials.
– Legal Compliance: Verification of adherence to federal and regional regulatory requirements,
including licensing, record retention, and reporting obligations.
 Inspection Process – Frequency
• Frequency of Inspection
– Determined by risk-based protocols.

– High-performing facilities with consistent compliance records may be

inspected less frequently.

– Facilities with repeated deficiencies, complaints, or those newly licensed

may undergo more frequent or unannounced inspections.
 Inspection Process – Self inspection
•Self-Inspection
– Self-inspection is a voluntary, internal quality assurance process conducted by
pharmacy or drug shop
– It involves reviewing all domains of the pharmacy or drug shop
– Regular self-inspections promote continuous improvement, ensure operational
quality, and enhance preparedness for external regulatory reviews
 Chapter Summary – Take Away Points
 Health systems strengthening aims to make health systems more resilient, efficient, and capable of
addressing the health needs of a population both now and in the future.
 Ensure all pharmaceutical regulations are grounded in national laws and standards that define the mandate
of RB.
 Enforce the requirements of pharmacies and drug shops to ensure uniform regulatory operations.
 Use “shall” for mandatory actions, “should” for recommendations, and “may” for discretionary actions, with
consistent interpretation across all the requirements.
 Conduct Regular Inspections: Implement routine and risk-based inspections to monitor compliance and
ensure continuous improvement.
 Educate stakeholders on regulatory requirements and processes to foster cooperation and accountability.
 References
• FDRE. Food and Medicine Administration Proclamation No. 1112/2019. Addis Ababa: Federal Democratic Republic of Ethiopia; 2019.
• FDRE. The Ethiopian Health Policy. Addis Ababa: Federal Democratic Republic of Ethiopia; 2024.
• Institute of Ethiopian Standards (IES). Pharmacy - requirements (CES 363:2024). Addis Ababa, Ethiopia: IES; 2024.
• Institute of Ethiopian Standards (IES). Drug shop - requirements (CES 362:2024). Addis Ababa, Ethiopia: IES; 2024.
• Institute of Ethiopian Standards (IES). Certification Scheme. Addis Ababa, Ethiopia: IES; 2024.
• Ethiopian Food and Drug Authority (EFDA). Community Pharmacy Implementation Guideline. Addis Ababa, Ethiopia: EFDA; 2024.
• Ethiopian Food, Medicine and Healthcare Administration and Control Authority. Inspection Manual for Inspectors. Addis Ababa, Ethiopia: EFMHACA; 2018.
• The Medicines, Technologies, and Pharmaceutical Services Program. Approaches and Tools for Strengthening Pharmaceutical Systems. Technical Brief, Published:
February 28, 2023. https://www.mtapsprogram.org/our-resources/approaches-and-tools-for-strengthening-pharmaceutical-systems/ accessed on April 07, 2025.
• Hafner T, Walkowiak H, Lee D, Aboagye-Nyame F. Defining pharmaceutical systems strengthening: concepts to enable measurement. Health Policy Plan. 2017 May
1;32(4):572-584. doi: 10.1093/heapol/czw153.
• Everybody’s business: strengthening health systems to improve health outcomes: WHO’s Framework for Action. Geneva: World Health Organization; 2007.
• Building health system resilience to public health challenges: guidance for implementation in countries. Geneva: World Health Organization; 2024. Licence: CC BY-
NC-SA 3.0 IGO.
Thank You for Your Attention