by Mr. Maroa Noa | Nov 25, 2025 | Operations, Risk Management, Strategy
Managing medical devices in Kenya demands strict compliance with the standards set by the Pharmacy and Poisons Board (PPB). These rules protect the public, promote product quality, and ensure that only safe devices reach the market.
In recent years, PPB has strengthened regulatory oversight to align Kenya with global best practices.
As a result, manufacturers, distributors, healthcare facilities, and importers must understand and follow these guidelines carefully.
Understanding PPB’s Role in Medical Device Regulation
The Pharmacy and Poisons Board serves as the national regulatory authority for medical devices in Kenya. PPB oversees all activities related to registration, importation, distribution, installation, usage, and post-market surveillance of medical devices.
PPB’s mandate ensures that every device placed on the Kenyan market meets approved standards for safety, performance, and quality. This protects patients from device failures and promotes trust in the healthcare system.
What Counts as a Medical Device in Kenya?
PPB defines a medical device as any instrument, apparatus, implant, machine, software, or material intended for medical purposes such as:
This definition includes items like syringes, blood pressure monitors, infusion pumps, surgical equipment, laboratory analyzers, and medical software.
Medical Device Classification under PPB
PPB classifies medical devices into four main categories based on risk level. Understanding this classification is essential because it determines:
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Required documentation
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Approval timelines
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Registration fees
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Post-market obligations
Class A – Low Risk
Examples: tongue depressors, surgical gloves, walking sticks.
Class B – Low to Moderate Risk
Examples: suction pumps, infusion sets.
Class C – Moderate to High Risk
Examples: ventilators, infusion pumps, neonatal incubators.
Class D – High Risk
Examples: defibrillators, heart valves, implantable pacemakers.
This classification aligns with the International Medical Device Regulators Forum (IMDRF) framework.
Registration Requirements for Medical Devices
PPB requires registration of all medical devices before placement on the Kenyan market. The process verifies product safety, quality, and compliance with technical standards.
Key Registration Requirements
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Manufacturer authorization
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Free Sale Certificate from country of origin
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Quality management system documentation (e.g., ISO 13485)
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Device description and intended use
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Clinical evaluation or performance data
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Risk classification
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Labeling and packaging information
The PPB registration process is managed through the UDES (Unified Drug and Device Electronic System) platform.
Importation & Distribution Requirements
PPB regulates the importation and distribution of all medical devices. No individual or company may import devices without proper licensing.
Importation Requirements
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Valid device registration
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Import license for medical devices
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Customs documentation
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Batch traceability records
PPB also verifies that distributors maintain quality systems that ensure proper storage, transportation, and handling of medical devices.
Installation and Usage Standards
Some devices require installation and calibration before use. PPB emphasizes proper installation by qualified personnel, especially for high-risk devices such as imaging equipment.
Facilities must ensure that:
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Installers are certified
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User training is documented
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Maintenance logs are kept
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Equipment is calibrated regularly
These measures reduce operational risks and enhance patient safety.
Post-Market Surveillance (PMS)
Post-market surveillance is a key component of PPB regulation. PPB continuously monitors medical devices already in use to detect:
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Quality issues
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Adverse events
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Device failures
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Counterfeit products
Healthcare facilities must report adverse events or device malfunctions promptly. This requirement helps PPB take action, including product recalls and safety notices.
Quality Control and Compliance
To maintain compliance, facilities and distributors must establish strong internal quality systems. These systems ensure proper handling, documentation, and monitoring of all medical devices.
Critical Compliance Practices
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Maintain updated device records
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Keep calibration certificates
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Report any safety concerns
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Follow storage requirements
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Train staff on device usage
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Renew import licenses and registrations promptly
Continuous compliance protects both patients and healthcare providers.
Common Non-Compliance Issues and How to Avoid Them
PPB regularly identifies gaps during inspections. Understanding these common issues helps organizations avoid penalties.
Frequent Non-Compliance Areas
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Importing unregistered devices
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Missing calibration records
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Poor device storage
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Incomplete documentation
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Failure to report adverse events
Organizations can avoid these mistakes by conducting internal audits and ensuring all documentation is up to date.
Why Compliance Matters
Compliance protects patient safety and enhances operational efficiency. It also strengthens business credibility and prevents legal penalties such as:
Following PPB guidelines ensures that healthcare providers deliver safe and reliable medical services.
How Clarity Pharma Consultancy Can Help
If you work with medical devices, navigating PPB regulations can feel overwhelming. Clarity Pharma Consultancysupports healthcare facilities, importers, and distributors by offering:
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Guidance on device registration
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Compliance audits
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Documentation support
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Importation and licensing assistance
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PMS reporting support
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Quality management advisory
Their expertise ensures your organization remains compliant and avoids regulatory challenges.
For consultation or regulatory assistance, consider partnering with Clarity Pharma Consultancy.
Managing medical devices under PPB regulations requires attention to detail, proper documentation, and ongoing compliance.
By understanding device classification, registration requirements, importation controls, and post-market obligations, organizations can operate safely and confidently. Staying compliant not only protects patients but also strengthens the entire healthcare system.
FAQs
by Mr. Maroa Noa | Nov 24, 2025 | Law, Operations, Strategy
When pharmaceutical products reach the Kenyan market, stakeholders must guarantee they meet rigorous quality standards. The Pharmacy and Poisons Board (PPB) has long mandated these standards and published guidance that laboratories must follow.
This article unpacks PPB’s quality manual (and analogous standards) to help you understand what pharmaceutical testing labs must do.
Understanding PPB’s Role in Laboratory Standards
The PPB exists under the Pharmacy and Poisons Act (Cap 244) in Kenya. It regulates manufacture, trade, import/export, registration, and quality of medicines. As part of this mandate, the PPB influences the standardisation of pharmaceutical testing laboratories.
Laboratories that test medicines must operate under recognised quality management systems to produce valid and reliable results.
Why a Quality Manual for Pharmaceutical Testing Matters
A quality manual sets the blueprint for how labs should operate and ensures consistent, high-quality outcomes. Without it, results may vary, risking public health, regulatory non-compliance, and loss of credibility. Globally, standards like ISO/IEC 17025 define the competence of testing labs.
When the PPB requires such frameworks, laboratories align with them to gain regulatory approval and maintain trust. In short, a strong quality manual = reliable test results + regulatory confidence + public safety.
Core Elements of a Laboratory Quality Manual for PPB Compliance
Here are the key topics your quality manual should cover:
Policies and Organisational Structure
Define the lab’s mission, scope of activities, and authority structure. Make clear who’s responsible for quality, competence, and compliance.
Describe how the facility meets PPB norms, including oversight, internal audits, and training programmes.
Document Control and Records Management
Establish procedures for version control of documents, secure storage of test records, and retention timelines.
Ensure records include calibration logs, reagent lot numbers, equipment maintenance, and test results.
Equipment, Calibration and Maintenance
State how equipment is selected, calibrated, qualified, and maintained.
Include schedules for preventive maintenance, calibration certificates, and logbooks.
Calibration traceability ensures test accuracy and aligns with external regulatory bodies.
Test Methods and Validation
Clearly document test methods (e.g., pharmacopoeial methods). Declare how methods are validated, verified, and reviewed.
Define acceptance criteria and how to handle deviations or out-of-specification results.
Ensure all standard operating procedures (SOPs) link to the manual.
Quality Control and Assurance
Include internal QC (e.g., control samples) and external QA (e.g., proficiency testing) programmes.
Cover how non-conforming work is managed, corrective actions implemented, and trends analysed.
Show how continuous improvement is embedded in lab culture.
Personnel and Training
Detail staff qualifications, roles, responsibilities, and training programmes.
Keep training records, supervise juniors, and update competency assessments regularly.
Safety, Environmental Conditions and Facilities
Define safe practices for handling hazardous materials, waste disposal, and chemical storage.
Ensure facility conditions (temperature, humidity) meet required tolerances for tests.
Show how the lab meets infrastructure requirements and environmental safety standards.
Monitoring, Audits and Review
Describe how internal audits occur, how management reviews take place, and how the quality manual is updated.
Continuous review ensures alignment with PPB updates and best-practice standards.
Practical Steps to Develop or Update Your Quality Manual
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Perform a Gap Analysis – Compare existing lab practices against PPB guidance and ISO/IEC 17025 fundamentals.
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Define Scope and Document Structure – Use clear headings, version controls, and table of contents.
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Draft Policies for Each Element – Write concise statements for each section above.
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Link SOPs and Records – Ensure each policy refers to relevant SOPs and forms.
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Train Staff on New Manual – Conduct workshops and obtain staff acknowledgement.
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Implement and Monitor – Execute the manual, run internal audits, capture non-conformances.
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Review Annually or On Regulatory Change – Adjust manual content when PPB or industry standards change.
How Clarity Pharma Consultancy Can Help
If you need expert guidance to develop, review or implement a laboratory quality manual aligned with PPB standards, Clarity Pharma Consultancy stands ready. We offer tailored support in documentation, staff training, audit preparation and regulatory readiness. Contact us for consulting services that ensure your laboratory meets the highest standards.
FAQs
by Mr. Maroa Noa | Nov 24, 2025 | Legal Framework, Operations, Strategy
Alcohol-based hand rubs (ABHRs) remain a key part of infection prevention in Kenya. Pharmacies across the country often produce these products to meet local demand, especially during public health emergencies.
However, the Pharmacy and Poisons Board (PPB) and the World Health Organization (WHO) provide strict guidelines to ensure that hand rubs are effective and safe for community use.
This article explains these requirements in a simple and practical way, giving Kenyan pharmacy operators a clear path toward compliant production.
Understanding Alcohol-Based Hand Rubs
Alcohol-based hand rubs are disinfectant formulations used to inactivate harmful microorganisms. They provide fast action and require no water, making them ideal for both community and clinical settings. WHO recommends ABHRs containing ethanol or isopropyl alcohol at specific concentrations to maintain antimicrobial activity.
Why Kenyan Pharmacies Must Follow Approved Guidelines
Regulatory compliance protects consumers and protects your pharmacy from penalties. PPB enforces production standards to ensure safety, prevent contamination, and reduce the circulation of substandard products.
Adhering to guidelines also builds trust. Customers are more likely to rely on pharmacies that follow scientific and regulatory instructions. Furthermore, compliant production promotes public health during outbreaks such as COVID-19, cholera, and flu waves.
Essential Ingredients for Hand Rub Production
A compliant alcohol-based hand rub must use high-quality pharmaceutical-grade ingredients. WHO recommends only four main ingredients:
1. Alcohol (Ethanol 80% v/v or Isopropyl Alcohol 75% v/v)
This is the active ingredient that kills germs. Concentrations lower than recommended weaken the product’s effectiveness.
2. Hydrogen Peroxide 3%
Hydrogen peroxide inactivates bacterial spores in the solution. It protects the formulation during storage but does not act on the skin.
3. Glycerol (Glycerine) 98%
Glycerol acts as a humectant, preventing skin dryness. Only small amounts are needed to maintain skin comfort.
4. Sterile Distilled or Boiled Water
Water is used to dilute the alcohol to the required concentration. Ordinary tap water is not allowed.
These ingredients must remain pure and uncontaminated. Kenyan pharmacies should source them from PPB-approved suppliers.
Required Equipment for Production
Safe production requires clean, well-organised pharmacy space and proper equipment. Common tools include:
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Measuring cylinders and beakers
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Stainless steel mixing containers
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Funnel and spouted bottles
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Alcoholometers for concentration verification
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PPE: gloves, masks, goggles
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Clean, dust-free working benches
Using food containers or unverified plastic bottles may lead to contamination or chemical reactions. Pharmacies should use chemical-resistant materials that comply with PPB and WHO guidelines.
Step-by-Step Production Process (WHO Standard Method)
Step 1: Prepare the Working Space
Begin by cleaning and disinfecting surfaces. Ensure good ventilation because alcohol vapors accumulate easily.
Step 2: Measure Ingredients Accurately
Use calibrated tools to avoid errors. Even small inaccuracies may alter the alcohol concentration, rendering the product ineffective.
Step 3: Mix Ingredients in the Correct Order
Add alcohol first, then hydrogen peroxide, followed by glycerol. Mix using sterile conditions. Finally, add water to achieve the exact volume.
Step 4: Transfer Solution to Storage Containers
Seal containers tightly to prevent evaporation. Alcohol evaporates quickly and any exposure reduces the final concentration.
Step 5: Label the Final Product Clearly
Labels should include:
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Product name
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Composition
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Production date
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Batch number
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Expiry date
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Storage instructions
Clear labelling helps pharmacies track quality and respond to customer queries.
Step 6: Store in a Cool, Controlled Environment
Keep the product away from heat and sunlight. High temperatures degrade alcohol concentration and compromise efficacy.
Regulatory Requirements in Kenya
1. PPB Approval
PPB regulates pharmaceutical manufacturing and compounding. Pharmacies producing hand rubs must comply with PPB compounding and good manufacturing practice (GMP) guidelines.
2. Quality Assurance
Pharmacies must verify alcohol concentration through alcoholometers or laboratory tests. Substandard products violate the Public Health Act and may attract penalties.
3. Documentation and Batch Records
Every batch must have clear records for traceability. These include quantities used, dates, staff involved, and final yields.
4. Packaging Requirements
PPB requires safe packaging, child-proof caps, and tamper-evident seals where possible.
5. Retail and Distribution Standards
Pharmacies must separate production from service areas to maintain hygiene and customer safety.
Common Mistakes to Avoid
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Using non-pharmaceutical-grade ingredients
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Inaccurate measurements that weaken alcohol concentration
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Storing hand rubs in hot environments
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Poor labelling
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Using unsterile bottles
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Ignoring PPE and hygiene protocols
Avoiding these mistakes protects consumers and improves product quality.
Safety Precautions for Pharmacy Staff
Alcohol-based products are highly flammable. Pharmacies must:
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Keep fire extinguishers nearby
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Avoid open flames and sparks
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Train staff on safe handling
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Ensure proper ventilation
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Store alcohol securely away from heat
These precautions reduce risks during production.
Why Quality Matters for Kenyan Pharmacies
High-quality hand rubs reduce infections within communities and healthcare environments. Kenya’s busy public spaces, transport systems, and hospitals rely heavily on effective sanitizers. Pharmacies that produce quality ABHRs fulfil a public health duty while building stronger customer trust.
Professional Support for Compliant Production
Pharmacies that want to improve their production processes can benefit from expert guidance. Clarity Pharma Consultancy offers support on regulatory compliance, WHO production protocols, PPB requirements, and quality assurance systems.
Their team helps pharmacies set up safe procedures and avoid common compliance errors in ABHR production.
FAQs
by Mr. Maroa Noa | Nov 24, 2025 | Legal, Operations, Strategy
Managing controlled substances in Kenya demands attention to detail, strong systems and full regulatory compliance. This article walks you through the key steps—from licences to safe-storage to record-keeping—so you can operate confidently and legally.
Understanding Controlled Substances in Kenya
In Kenya, the regulation of drugs and poisons falls under the Pharmacy and Poisons Board (PPB) established via the Pharmacy and Poisons Act (Cap 244).
The Act gives the Board powers to make rules relating to “safe custody and storage of poisons” and to require registers and books to be kept.
Controlled substances typically include Part I poisons and other regulated medicines. You must treat them with stricter control.
Licensing: Getting Authorised to Handle Controlled Substances
Before you handle controlled substances, you must ensure proper licensing:
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Apply for the correct licence via the PPB’s Online Licensing portal.
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Ensure your business registration and professional staff (e.g., a registered pharmacist) are in place.
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Submit documentation for premises, storage, and security arrangements.
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Await inspection and approval before stocking or dispensing controlled substances.
By securing the correct licence, you mitigate risks of non-compliance and enforcement action.
Storage & Safe Custody: Protecting Controlled Substances
Once licensed, proper storage becomes crucial.
Key Storage Practices
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Store controlled substances in a separate room or compartment locked and clearly labelled “Poisons Only”.
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Restrict access so that only authorised personnel can reach the controlled substance area.
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Keep storage physically apart from food or drink, and maintain environmental conditions (temperature, light, humidity) appropriate for the medicines.
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Ensure containers are appropriate, secure, and clearly labelled. The law demands poisons be placed in impervious containers and sealed properly.
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Periodic inspections—within your own facility—help monitor storage integrity and prevent diversion or theft.
By applying these measures you maintain integrity of your stock and protect public health.
Record-Keeping: Tracking, Auditing & Compliance
Accurate records form the backbone of your system for controlled substances.
What to Document
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Maintain a Poison Book or equivalent register for Part I poisons as required under the Act and Rules.
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Log incoming quantities (batch numbers, expiry dates), outgoing supplies, prescriptions filled, returns and destructions.
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Ensure records are retained for the time period specified by law and are readily available for inspection.
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Conduct internal audits regularly to reconcile stock, compare with records and identify discrepancies early.
Records help you trace each unit of controlled substance from receipt to dispensing or disposal.
Inspection & Audit: What Regulators Expect
The PPB and authorised officers hold statutory powers to inspect your premises, paperwork and storage.
During an inspection they will check:
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Licence validity and display
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Storage conditions (locked, labelled, separated)
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Record-books and registers
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Proof of authorised personnel handling the substances
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Compliance with rules on supply and possession
Preparing in advance reduces risk of penalties and operational disruptions.
Common Compliance Mistakes & How to Avoid Them
Here are typical pitfalls—and how you can avoid them:
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Mistake: Storing controlled substances alongside general stock or food.
Solution: Create a dedicated locked compartment and train staff accordingly.
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Mistake: Failing to maintain up-to-date registers.
Solution: Use daily logs and reconcile monthly.
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Mistake: Operating without the correct licence or registration.
Solution: Verify licencing status before handling any controlled substance.
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Mistake: Delayed inspection preparation.
Solution: Implement regular mock audits and keep documentation ready.
Avoiding these helps you stay compliant and safeguard your business.
Best Practices: Building a Robust Compliance System
To operate at a high standard, follow these practices:
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Develop standard operating procedures (SOPs) for receipt, storage, dispensing and destruction of controlled substances.
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Train all staff in the rules: Part I poisons, lock-and-key storage, record-keeping.
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Schedule regular internal audits (weekly/monthly) to check logs and stock.
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Review licences and registrations annually and renew on time.
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Display your licence and relevant signage prominently in your facility.
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Use technology where possible: digital registers, barcode systems, alerts for expiry and stock discrepancies.
By embedding compliance into your daily operations you stay ahead of regulation and reassure stakeholders.
How Clarity Pharma Consultancy Can Support You
If navigating licences, storage rules and record-keeping for controlled substances seems complex, you’re not alone. At Clarity Pharma Consultancy we support Kenyan health-sector businesses with:
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Regulatory gap analyses and readiness checks
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Licence application assistance with the PPB
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Designing secure storage facilities and SOP documentation
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Staff training on controlled substance handling and record systems
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Internal audit frameworks and mock inspections
Partner with us to ensure you stay compliant, minimise risk and maintain smooth operations.
Handling controlled substances in Kenya requires more than just compliance—it demands a system. Licensing under the PPB, secure storage, meticulous record-keeping and proactive auditing form the core of a strong compliance programme.
When you build solid practices and partner with knowledgeable consultants, you safeguard your business, patients and reputation.
FAQs
by Mr. Maroa Noa | Nov 24, 2025 | Operations, Strategy
n Kenya, regulatory efficiency matters. The Pharmacy and Poisons Board (PPB) has introduced a set of reliance mechanisms. These mechanisms allow the agency to leverage decisions from trusted regulators. In doing so, they speed up medicine approvals without compromising safety, efficacy or quality.
This article explains what reliance mechanisms are, how they work in Kenya, and what companies need to do to take advantage of them.
What Are Reliance Mechanisms?
A reliance mechanism is a regulatory tool where one national regulatory authority gives significant weight to the work performed by another trusted regulator when approving a medicine.
The World Health Organization defines this approach as beneficial in optimising resources and improving timelines.
In Kenya’s context, the PPB issued the “Guidelines on Reliance Mechanisms for Marketing Authorization of Health Products and Technologies in Kenya”. These guidelines create pathways for faster approvals by recognising work done by reference authorities, reducing duplication.
Why Kenya Needs Faster Medicine Approvals
Kenya faces increasing pressure to deliver essential medicines timely. Demand for new treatments, emerging diseases and technology‐driven innovations have grown. By adopting reliance pathways, the PPB aims to reduce regulatory bottlenecks and improve access.
Also, global regulatory convergence encourages Kenya to align with international best practice. A recent workshop in Nairobi highlighted the low adoption but significant potential of reliance approaches in Kenya.
The Legal and Regulatory Framework
The PPB derives its mandate from the Pharmacy and Poisons Act and supportive regulations such as the Medicines and Allied Substances Act (as amended).
Under these laws, the PPB may approve, suspend or revoke marketing authorisations. With the new reliance guideline, the PPB formalises the use of trusted regulators’ assessments to inform its decisions.
Key Reliance Pathways Introduced by PPB
1. Reference Regulator Pathway
This pathway accepts a marketing authorisation granted by a recognised stringent or well-established regulatory authority. The PPB then uses that approval as a basis to expedite review.
2. Work-sharing or Collaborative Review Pathway
Applicants submit data simultaneously to multiple jurisdictions. The PPB may coordinate with other regulators and leverage their findings to shorten timelines.
3. Verification or Abridged Review Pathway
For products already approved elsewhere, the PPB conducts a targeted review of specific modules (such as manufacturing or clinical summary) instead of full standard review.
4. Emergency/Expedited Reliance Pathway
In public health emergencies, the PPB may use reliance mechanisms to fast-track approvals of vital medicines or vaccines.
Benefits of Using Reliance Mechanisms
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Shorter approval timelines – Applicants spend less time waiting for decisions.
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Reduced duplication of effort – The PPB uses existing assessments from trusted regulators, reducing the burden on applicants.
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Resource optimisation – The regulator can focus its resources on high-risk products and post-market surveillance.
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Improved access – Patients gain faster access to new, safe, effective medicines.
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Global alignment – Kenya signals commitment to regulatory convergence and international standards.
Practical Steps for Applicants: Navigating the Reliance Pathways
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Check eligibility – Verify whether the product is approved by a recognised reference regulator and meets the criteria in the guideline.
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Prepare a robust dossier – Include a summary of the reference agency’s approval, quality/manufacturing data, clinical evidence and safety profile.
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Engage with PPB early – Consider pre-submission meetings to clarify which reliance pathway applies and what supporting documents are needed.
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Submit through the designated online portal – Use PPB’s submission channel and tag the application as “Reliance Pathway”.
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Respond promptly to queries – Once submitted, engage quickly with regulators to avoid delays.
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Plan for post-market obligations – Even with reliance pathways, maintain pharmacovigilance, manufacturing oversight and local registration obligations.
Challenges and Considerations
The reliance model brings advantages but also challenges:
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Data transparency – Companies must supply unredacted reports from reference regulators.
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Local relevance – The regulator still assesses local context, disease profile and manufacturing site suitability.
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Infrastructure/Capacity – PPB and applicants need strong systems to handle reliance workflows. As one workshop found, industry awareness and regulatory capacity remain gaps in Kenya.
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Legal clarity – The guideline is relatively recent and stakeholders must monitor updates as practice evolves.
How Clarity Pharma Consultancy Can Help
If you are an innovator, manufacturer or distributor looking to leverage Kenya’s reliance pathways, Clarity Pharma Consultancy offers expert support.
We guide clients through the eligibility assessment, dossier preparation, submission planning, regulator engagement and post-market compliance.
Contact us for a tailored consultation and ensure your products are fast-tracked under Kenya’s reliance framework.
Kenya’s adoption of reliance mechanisms marks an important step toward faster, efficient, and safe access to medicines. The PPB’s guideline sets out clear pathways that reduce duplication and speed review without lowering standards. If you plan to register your product in Kenya, understanding and leveraging these mechanisms becomes vital. Early engagement, precise documentation and strategic planning position you for success.
FAQs
by Mr. Maroa Noa | Nov 21, 2025 | Legal Framework, Marketing, Risk Management
When you hold marketing authorisation for a medicine in Kenya, it is vital to keep it updated. Regulatory authorities expect any change—minor or major—to be reported promptly. In Kenya the Pharmacy and Poisons Act (Cap 244) and the associated rules govern such changes.
This article guides you through what you must know, how you should act, and how your business can remain fully compliant.
Understanding What “Changes to Registered Medicines” Means
A “change” or “variation” refers to any alteration in a registered medicine’s details after its approval. Examples include:
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A new manufacturing site,
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Changes in formulation or strength,
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Label or packaging changes,
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Change in distribution channel or licence holder,
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New indication or withdrawal of an indication.
Under the Rules, the Pharmacy and Poisons Board (PPB) must be notified of any alteration that could affect safety, efficacy or quality.
Staying proactive helps avoid enforcement action, delays in marketing or supply disruptions.
When Should You Submit a Change?
You should submit a variation:
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Before implementing the change, if it is major (e.g., manufacturing site, formulation).
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Within a defined timeframe after implementing smaller changes (e.g., labelling wording).
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Immediately when there is a safety-related change (e.g., adverse event, defect).
Failing to notify the regulator may lead to revocation of your registration certificate.
Key Requirements for Submitting a Variation
Here are the main compliance elements when preparing your submission:
Document the Change Clearly
You must describe the change, rationale, supporting data and impact on product quality, safety or efficacy.
The PPB’s guideline emphasises structured dossiers for variations.
Refer to the Legal Framework
Ensure your submission aligns with the Pharmacy & Poisons Act (Cap 244) and Regulations.
Use the Online Portal
The PPB requires submissions through its portal (for instance for registration and renewals).
Pay Applicable Fees
Variations may carry fees or retention requirements depending on the type of change and timeframe. Consult the current fee schedule.
Keep Records and Track Changes
Document the change, internal approvals, and retain submission proof. That helps during inspections or audits.
Step-by-Step Process to Submit a Change
Here’s a practical sequence you can follow:
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Assess the Nature of the Change
Determine whether the change is minor, major or safety-related.
Minor: packaging, non-critical labelling text.
Major: formulation, manufacturing site, indication.
Safety-related: adverse reaction, defect.
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Prepare Supporting Data
For major changes, include technical documents: justification, validation, stability, risk assessment.
The PPB guideline highlights the need for detailed information especially for APIs and finished products.
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Complete Variation Application Form
Log into the PPB submission portal → fill the variation request form → attach required documents.
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Submit Payment and Application
Ensure fees are paid. Submit the form with supporting documents via the portal or according to PPB instructions.
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Await Acknowledgement and Reference Number
The PPB assigns a submission number. Use it for tracking and communication.
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Implement the Change (if allowed) or Wait for Approval
Some major changes require PPB approval before implementation. For minor ones, you may implement while awaiting formal acknowledgement (depending on PPB policy).
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Monitor the Review Process
Respond to queries from PPB promptly. Delay may result in rejection or request for more data.
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Receive Variation Approval
Upon approval, update your marketing documents, labels, packaging and supply chain accordingly.
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Update Internal Systems and Records
Inform relevant stakeholders, update SOPs, quality systems, staff training.
Best Practices to Improve Your Submission Success
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Use clear, active-voice language in your submission.
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Label documents with version numbers and dates.
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Keep paragraphs short and headings distinct for readability.
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Provide a cover letter summarising the change.
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Use transition words like “furthermore”, “consequently”, “therefore” to ensure flow.
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Link to authoritative external sources to support your rationale.
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Maintain high-quality formatting, naming conventions and consistent references.
How Clarity Pharma Consultancy Can Assist You
If you need expert support navigating variation submissions to the PPB, we can help. At Clarity Pharma Consultancy, our team guides you through regulatory classification of change, dossier preparation, submission tracking and compliance assurance. We ensure your product stays compliant and supply continuity remains intact.
FAQs
by Mr. Maroa Noa | Nov 21, 2025 | Legal Framework, Marketing, Operations
In today’s global market, pharmaceutical supply chains face increasing risks and complexity. You must plan well, coordinate stakeholders, follow regulations, and deploy the right controls.
This article guides you step-by-step through best practices for securing pharmaceutical imports and exports, making your operations stronger and compliant.
Understanding the Importance of Supply Chain Security
A secure supply chain ensures that medicines remain safe, effective and authentic from origin to patient. It prevents counterfeits, product damage, regulatory breach and brand harm.
For companies involved in imports or exports, weak links in logistics, documentation or traceability can lead to major losses and reputational damage.
According to one review, pharmaceutical supply chains must manage regulatory compliance, complex networks of suppliers and the growing risk of counterfeits.
Key Regulatory Requirements for Imports & Exports
Before shipping or receiving pharmaceuticals across borders, you must know the rules. For example, Pharmacy and Poisons Board in Kenya publishes the Guideline on Import and Export of Health Products and Technologies, which emphasises the need for regulatory oversight for imports and exports, to prevent substandard or falsified products.
Elsewhere, Good Distribution Practices (GDP) define standards for how products must be stored, transported and traced.
Best Practices at Each Stage of the Supply Chain
Here are practices you should adopt for every major phase of your import or export cycle.
Supplier and Manufacturer Selection
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Choose suppliers with strong quality systems and certifications.
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Conduct audits of manufacturing sites, packaging and distribution.
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Require transparency about component sourcing and subcontractors.
Documentation & Regulatory Compliance
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Prepare accurate import/export customs documentation, licences and permits.
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Label shipments clearly with lot numbers, expiry dates, handling instructions.
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Validate that products meet destination country regulatory standards.
Packaging, Storage & Transportation
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Use validated packaging that maintains required conditions (temperature, humidity).
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Monitor cold-chain shipments with sensors and alerts.
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Track shipments in real-time and record environmental data.
Traceability & Anti-Counterfeiting Measures
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Assign unique identifiers to shipments and batches.
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Consider technologies like blockchain or IoT for traceability.
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Secure seals, tamper-evident packaging, and random checks.
Customs Clearance & Border Management
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Ensure correct classification of products, tariffs, duty exemptions where applicable.
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Coordinate with logistics providers, customs brokers and regulators.
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Plan for inspections, delays and documentation mismatches.
Risk Management & Contingency Planning
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Map out risks: supplier failure, transport disruption, regulatory changes, natural disasters. ResearchGate
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Maintain safety stocks or alternate sources.
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Monitor for alerts: recalls, counterfeit reports, import bans.
Continuous Monitoring & Audit
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Perform regular internal audits of supply-chain practices and vendor performance.
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Implement corrective and preventive actions (CAPAs) when deviations occur.
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Review KPIs: lead time, temperature excursions, shipment damage, regulatory findings.
How Technology Supports Supply Chain Security
Modern technologies provide strong support:
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IoT sensors monitor temperature, humidity and location in real-time for shipments.
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Blockchain ledgers ensure immutable records of product origin and movement.
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Advanced analytics / AI predict demand, identify risk patterns and optimise supply-chain networks.
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Digital platforms manage documentation, compliance tracking and stakeholder collaboration.
Challenges You Should Be Aware Of
Despite best efforts, you may still face headwinds:
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Varying regulatory frameworks across countries complicate compliance.
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Cold-chain logistics remain expensive and prone to failure.
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Counterfeiting and diversion stay persistent, especially in complex networks.
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Data visibility across multiple tiers of suppliers is often limited.
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Disruptions (pandemics, geopolitics, transport delays) continue to test resilience.
Practical Checklist for Importers & Exporters
Use this checklist to ensure you cover all bases:
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Verify supplier credentials and quality system.
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Confirm destination country import permits and regulatory standards.
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Package and label products according to GDP and local laws.
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Monitor shipment conditions and track real-time data.
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Maintain complete documentation: invoices, licences, certificates of analysis.
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Register unique identifiers for traceability and anti-tampering.
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Coordinate customs, logistics, regulatory stakeholders early.
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Conduct periodic audits and risk assessments of your network.
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Implement a contingency plan for disruptions (alternate routes, suppliers).
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Review performance metrics regularly and adjust operations as needed.
How Clarity Pharma Consultancy Can Help
At Clarity Pharma Consultancy, we support pharmaceutical importers and exporters in building secure, compliant, and resilient supply chains.
We offer:
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Compliance review and regulatory gap analysis
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Supply-chain audit and vendor assessment
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Cold-chain validation and monitoring setup
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Traceability strategy using technology tools
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Documentation and customs advisory
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Training for staff in supply-chain best practices
If you want to fortify your pharmaceutical imports/exports and minimise risk, contact us today to schedule a consultation.
FAQs
by Mr. Maroa Noa | Nov 20, 2025 | Marketing, Operations, Strategy
Trust is the foundation of every successful healthcare interaction, especially in pharmacy practice. In Kenya, patients rely on pharmacists not only for medications but also for guidance, assurance, and accurate health information.
As healthcare continues to evolve, Good Pharmacy Practice (GPP) has become an essential framework for enhancing professionalism, accountability, and quality service delivery.
GPP provides clearly defined standards that help pharmacists offer safe, ethical, and patient-centered care. When these standards are consistently applied, patients feel valued, informed, and protected—leading to better health outcomes and stronger relationships between pharmacists and the community.
Understanding Good Pharmacy Practice (GPP) in Kenya
Good Pharmacy Practice refers to the standards set to ensure that pharmacists deliver quality pharmaceutical care responsibly and safely. In Kenya, GPP is guided by the Pharmacy and Poisons Board (PPB), which outlines the minimum requirements for ethical practice, patient safety, and professional conduct.
GPP also aligns with international recommendations issued by the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP). These guidelines emphasize the need for competent, patient-focused services across all pharmaceutical settings.
Why Trust Matters in Pharmacy Practice
Trust influences how patients follow treatment plans, share accurate health information, and return for continued care. When patients trust their pharmacists, they feel confident about medication use and are more likely to avoid harmful self-medication.
Moreover, trusted pharmacists play a key role in public health by providing reliable advice on immunization, chronic disease management, and rational drug use.
In environments where misinformation is common, trust becomes a critical protective factor for community well-being.
Core Principles of Good Pharmacy Practice (GPP)
1. Patient-Centered Care
GPP emphasizes that every pharmacy interaction should prioritize patient needs. Pharmacists must offer individualized counseling, listen actively, and ensure each patient understands their treatment.
Through patient-centered care, pharmacists strengthen relationships built on empathy, respect, and clear communication. This approach improves adherence and empowers patients to take control of their health.
2. Professional Competence and Continuous Learning
Pharmacists must remain competent by updating their knowledge and staying informed about new therapies, safety alerts, and emerging diseases. In Kenya, PPB requires pharmacists to participate in Continuing Professional Development (CPD) programs.
Continuous learning ensures pharmacies maintain high professional standards and provide patients with safe, evidence-based recommendations.
3. Ethical and Responsible Service Delivery
Ethical practice is central to GPP implementation. Pharmacists must protect patient confidentiality, avoid conflicts of interest, and make decisions that put patient safety first.
Responsible service delivery also means refusing to dispense medications without valid prescriptions and reporting suspected misuse. These measures protect patients and promote responsible pharmaceutical use.
4. Quality Assurance and Safety Standards
GPP requires pharmacies to maintain strict quality control measures from medication procurement to dispensing. These measures include proper storage conditions, batch tracking, and adherence to expiry-date protocols.
With strong quality assurance systems in place, patients receive genuine, safe, and effective medications. This transparency strengthens their confidence in the pharmacy’s services.
5. Effective Communication and Counseling
Clear, friendly, and professional communication helps patients understand their medications and avoid dangerous errors. Pharmacists should use simple language, check for understanding, and encourage patients to ask questions.
Good counseling supports better health outcomes and prevents confusion, especially among patients managing chronic illnesses.
Implementing GPP in Kenyan Pharmacies
1. Strengthening Standard Operating Procedures (SOPs)
Pharmacies must establish SOPs that outline daily workflows for dispensing, record-keeping, counseling, and handling controlled substances. SOPs ensure consistency and reduce risks related to human error.
Additionally, SOPs help new staff integrate smoothly while maintaining the organization’s expected service standards.
2. Enhancing Pharmacy Infrastructure
A well-organized pharmacy signals professionalism and competence. Clean counters, well-labeled shelves, and secure storage areas demonstrate the pharmacist’s commitment to safety.
Modern infrastructure—such as computerized stock systems—also reduces errors and enhances service efficiency.
3. Training and Empowering Pharmacy Staff
Support staff such as technicians and assistants must receive proper training to maintain the integrity of GPP standards. Skilled staff create a seamless patient experience and reduce unnecessary delays.
Furthermore, empowered staff contribute to a culture of accountability and teamwork.
4. Promoting Digital Health Tools
Digital tools improve efficiency, accuracy, and patient engagement. Electronic dispensing systems, telepharmacy, and digital recordkeeping support faster decision-making and reduce medication errors.
In Kenya, digital platforms also help pharmacies collaborate with insurers, clinicians, and supply chains to improve service quality.
5. Ensuring Transparency in Pricing and Medication Availability
Patients value honesty and clarity. Transparent pricing builds trust and prevents misunderstandings. Pharmacies should clearly display service charges and inform patients about affordable generic options when appropriate.
Additionally, keeping essential medicines in stock reduces frustrations and enhances trust.
How GPP Builds Trust with Patients
Implementing GPP creates a safe environment where patients feel respected and protected. When pharmacies operate ethically and professionally, patients develop long-term loyalty.
Moreover, GPP reduces medication errors, improves patient understanding, and ensures ethical responsibility. These efforts build credibility, strengthen community confidence, and enhance public health outcomes.
The Role of Technology in Advancing GPP in Kenya
Technology is reshaping pharmacy practice in Kenya. Digital prescription systems, automated stock management, and online patient education improve accuracy and efficiency.
Furthermore, technology helps pharmacists track patient history, identify interactions, and provide personalized care. These capabilities enhance safety and foster deeper patient trust.
Regulatory Bodies Supporting GPP in Kenya
Kenya’s regulatory ecosystem supports GPP through strict licensing, inspection, and compliance protocols. Key bodies include:
These institutions ensure pharmacies uphold standards that promote patient safety and trust.
How Pharmacies Can Strengthen Patient Engagement
Pharmacies can adopt simple but effective strategies to engage patients:
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Provide friendly consultations.
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Offer follow-up support for chronic conditions.
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Educate patients on proper medication use.
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Guide patients on preventive care services.
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Use digital reminders for refills and monitoring.
Such strategies demonstrate commitment, deepen patient relationships, and enhance community trust.
Challenges Affecting GPP Implementation in Kenya
Pharmacies often face challenges such as limited staffing, high patient volumes, and supply chain inconsistencies. Additionally, counterfeit medications and rapid changes in treatment guidelines create operational pressure.
However, through professional collaboration, government support, and continuous training, pharmacies can overcome these challenges and improve service quality.
Good Pharmacy Practice forms the backbone of trustworthy, reliable, and patient-centered pharmacy services in Kenya. By applying GPP principles, pharmacies strengthen patient relationships, reduce errors, and deliver safe, ethical, and high-quality healthcare.
As the sector continues to evolve, embracing GPP remains essential for building strong, lasting trust between pharmacists and the communities they serve.
FAQs
by Mr. Maroa Noa | Nov 20, 2025 | Legal, Legal Framework, Marketing
Medicine advertising influences how people choose and use pharmaceutical products. When the information is misleading or exaggerated, the public faces serious risks.
Because of this, the Pharmacy and Poisons Board (PPB) plays a central role in protecting Kenyans from unsafe promotion.
Through strict guidelines, consistent monitoring, and strong enforcement, the PPB ensures advertising remains responsible, truthful, and safe.
What Is the Pharmacy and Poisons Board (PPB)?
The PPB is Kenya’s national drug regulatory authority established under the Pharmacy and Poisons Act (Cap 244).
It oversees the quality, safety, and efficacy of all human medicines circulating in the country. In addition, the Board regulates every stage of the pharmaceutical chain—from manufacture and importation to distribution and promotion.
Why Regulating Medicine Advertising Matters
1. Preventing Misleading Claims
Misleading advertisements can cause people to trust medicines that do not work or that they do not need. Because of this risk, the PPB reviews every advertisement to ensure the claims remain factual. This approach prevents exploitation and protects vulnerable groups.
2. Reducing Self-Medication and Misuse
Aggressive promotion may encourage people to self-prescribe. As a result, they may delay proper treatment or overdose. By regulating advertisements, the PPB limits harmful self-medication and promotes safer health-seeking behavior.
3. Combating Counterfeit or Unapproved Medicines
Kenya faces challenges with counterfeit and illegal pharmaceuticals. Therefore, monitoring advertisements helps block unregistered or dangerous products from reaching the public. This enforcement reduces exposure to unsafe medicines.
4. Promoting Rational Use of Medicines
When advertisements remain accurate, people learn the correct uses and limitations of medicines. Consequently, the public benefits from better treatment outcomes and fewer complications.
How the PPB Regulates Medicine Advertising
1. Advertisement Approval Process
Before any medicine is advertised in Kenya, the PPB must issue written approval. Applicants submit an official form, pay a review fee, and provide the exact wording intended for public use.
This early review ensures every claim aligns with scientific evidence. It also filters out false and exaggerated promotional language.
2. Restrictions on Certain Disease Claims
The Pharmacy and Poisons Act prohibits advertisements that claim to cure certain severe conditions. These include cancer, tuberculosis, epilepsy, diabetes, and several other chronic diseases.
Because such conditions require specialized care, the Board blocks advertisements that may misguide desperate patients.
3. Reviewing Content for Accuracy and Balance
The PPB examines every message to ensure it does not oversell benefits or hide risks. When an advert appears extravagant or misleading, the Board rejects it or demands corrections.
These checks ensure that marketing focuses on facts rather than sensational promises.
4. Penalties for Non-Compliance
Companies that advertise without approval or violate advertising rules face fines or imprisonment. Offenders risk penalties such as fines up to KSh 20,000 or a year in jail for a first offence.
Since repeated breaches attract heavier punishment, organizations are encouraged to comply.
The PPB’s Wider Role in Protecting Public Health
1. Market Authorization and Licensing
Before a medicine reaches the market, the PPB evaluates it for safety, quality, and effectiveness. Once approved, the Board licenses manufacturers, distributors, and pharmacies. This licensing system ensures that only trained and certified professionals handle pharmaceuticals.
2. Pharmacovigilance and Post-Market Monitoring
Even after approval, medicines require continuous monitoring. Therefore, the PPB collects reports of side effects through its pharmacovigilance program. It also performs post-market surveillance to confirm that products in circulation meet safety standards. When risks appear, the Board issues warnings or recalls.
3. Enforcement Against Illegal Pharmaceutical Trade
The PPB regularly partners with police and county governments to shut down illegal pharmacies and seize unregistered medicines. These operations help maintain a safe pharmaceutical environment and protect communities from harmful products.
4. Public Awareness and Education
Beyond inspections and approvals, the PPB invests in public education. Through advisories, social media updates, and community outreach, the Board encourages responsible medicine use and alerts the public to emerging threats.
Key Challenges Faced by the PPB
Even with strong systems in place, the PPB faces several obstacles:
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Growth of online advertising, which spreads unverified claims quickly.
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Resource constraints, which limit monitoring capacity.
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Low public awareness, especially in rural regions.
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Emerging digital marketing tactics, such as influencer promotions.
Because the pharmaceutical environment keeps evolving, the PPB must continually strengthen its strategies.
Why the PPB’s Role Is Essential for Kenyans
Kenya’s public health relies heavily on accurate drug information. When advertisements are truthful and regulated, people can make informed decisions about their health.
Moreover, strict oversight builds confidence in the healthcare system and prevents exploitation. Ultimately, PPB’s role in regulating advertising contributes directly to safer, healthier communities.
The PPB plays a crucial role in safeguarding public health in Kenya. By regulating medicine advertising, approving products, monitoring safety, and enforcing laws, the Board prevents misinformation and protects consumers from harm.
As advertising grows more creative and digital, the PPB continues to strengthen its oversight to ensure that every promotional message remains accurate, honest, and safe.
FAQs
by Mr. Maroa Noa | Nov 20, 2025 | Legal, Marketing, Operations
In recent years, Kenya’s Pharmacy and Poisons Board (PPB) has embraced digital transformation by shifting many of its permit and licensing processes online.
This strategic move strengthens regulatory efficiency, improves stakeholder experience, and enhances transparency.
In this article, we’ll explore how this journey is unfolding, its benefits, and what it means for pharmacists, drug distributors, and the general public.
Why PPB Went Digital
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Enhancing Efficiency
By digitizing licensing processes, the PPB significantly reduces paperwork, manual processing, and human error. Stakeholders can now apply, pay, and monitor their applications in real time via the PPB Online Services Portal.
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Promoting Transparency
Online systems allow real‑time tracking of license status, so applicants always know where they stand. This reduces opacity and helps curb corrupt practices.
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Boosting Compliance
The automated portal encourages higher compliance since it’s easier, faster, and more accessible. Stakeholders are more likely to renew their licenses and follow regulations.
Key Components of the PPB Online Permits & Licenses System
1. Online Services Portal
Through the PPB Online Services Portal, users can register an account, apply for various licenses, make payments, and download permits. This all-in-one platform streamlines the entire regulatory lifecycle.
2. eCitizen Integration
To access many PPB online services, users must log in via eCitizen, Kenya’s central government services portal. This ensures identity verification, enhances security, and aligns PPB services with national digital infrastructure.
3. Licensing for Premises and Practitioners
The PPB regulates both pharmacy premises and the practitioners (pharmacists, pharmaceutical technologists). Licenses for premises, annual practice, and other permits now go through the online system, speeding up approval and renewal.
4. Online Exams for Pharmacists
PPB now uses its portal to manage professional exams. For example, in June 2025, candidates registered and sat for online pre-registration and enrollment exams via the online system. This process reduces administrative burdens and improves accessibility.
5. Pharmacovigilance & Clinical Trials
Beyond routine licensure, PPB’s digital infrastructure supports clinical trial registration and pharmacovigilance reporting. Their Clinical Trials Registry and Electronic Pharmacovigilance Reporting System help streamline regulatory oversight of drug safety.
Major Benefits of the Digital Shift
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Speed: Applications that once took weeks can now be processed faster due to electronic workflows.
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Accessibility: Stakeholders anywhere in Kenya can apply for licenses, check status, or renew without physically visiting PPB offices.
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Cost-savings: Reduces costs for both PPB and applicants (e.g., less paper, fewer visits).
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Better Tracking & Auditing: Digital logs make it easier to audit applications, detect fraud, and ensure accountability.
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Public Safety: With a live, updated register of licensed pharmacies, the public can verify the legitimacy of outlets — even by scanning QR codes on licenses.
Challenges & How PPB Is Addressing Them
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Digital Literacy: Not all stakeholders may be comfortable with online systems. The PPB may need to provide training or user guides.
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Internet Access: In remote areas, poor connectivity could hinder use of the portal. PPB may collaborate with local agencies to provide support.
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Security Risks: Handling sensitive data online requires robust cybersecurity. PPB’s integration with eCitizen helps by leveraging existing secure identity systems.
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Regulatory Adaptation: As services go digital (e.g., online pharmacies), PPB has proposed new rules to manage online prescribing, counselling, and medicine sales.
The Impact on Stakeholders
Pharmacists & Pharmaceutical Technologists
They benefit from simplified license renewals, faster permit approvals, and a centralized dashboard where they can track their submissions.
Pharmacy Owners / Premises
Owners can apply for premises registration, submit required documents online, and map compliance against PPB standards.
Drug Manufacturers & Importers
These parties can apply for Good Manufacturing Practice (GMP) inspections via digital forms. The portal also supports import/export registration, reducing bureaucratic delays.
Public / Consumers
Members of the public can verify if a pharmacy is licensed by checking PPB’s online registry — and even scanning a QR code on the displayed license. This boosts trust and safety.
Regulators
PPB itself gains from more streamlined internal workflows, better data, and improved capacity to enforce compliance.
Future Outlook
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Expansion of Services: We may see more modules on the portal covering inspections, drug waste disposal, and enforcement.
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Enhanced Analytics: Digital data gives PPB insights into licensing trends, compliance gaps, and risk areas.
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Interoperability: The portal could integrate with other government systems (e.g., health records, national trade systems) to create synergies.
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Regulating Online Pharmacies: As digital pharmacies grow, the PPB is expected to continue developing stricter regulatory frameworks.
The digital transformation at PPB marks a pivotal moment for Kenya’s pharmaceutical regulatory sector. By moving permits and licenses online, the Board not only enhances efficiency, but also strengthens transparency, compliance, and public trust.
This shift helps all stakeholders—from pharmacists and business owners to everyday Kenyans—navigate the system more easily.
As PPB continues to evolve, its focus on innovation and accessibility promises to shape a safer, more regulated pharmaceutical landscape.
FAQs
