Scope

Applies to all health supplements intended for importation, manufacture, sale, or distribution within Kenya.

Main Content

• Application Requirements– dossier submission with product composition, manufacturing details, quality control measures, safety information, and labelling.
• Evaluation Criteria– safety (toxicological profile, history of safe use), quality (GMP compliance, stability data, specifications), and accurate representation of ingredients.
• Labelling & Claims– labelling and allowable health maintenance or nutritional claims. Specific annexures provide permitted dosage ranges and claim wordings for various categories of supplements.
• Post-Market Surveillance of food supplements

Objective

To regulate the safe use and fair marketing of health supplements, safeguarding public health while facilitating access to beneficial products.

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Kenya, was established under the Pharmacy and Poisons Act, Cap 244 laws of Kenya with a mandate to protect the health of the public by regulating the profession of pharmacy and ensuring the quality, safety and efficacy of medical products and health technologies. Pursuant to this mission and the ultimate goal of Medically Assisted Therapy (MAT) to reduce harmful health, psychological and socioeconomic consequences of drug use, PPB developed this guideline to provide a broad regulatory guide and a framework for the management of Pharmaceutical services within MAT Clinics and standardize MAT Pharmacy set up and Pharmacy Practice in both the Public and Private sectors and hence to establish national consistency in approach, while acknowledging responsibility for health care and legal requirements relating to Narcotic and Psychotropic Substances. The pharmacy and poisons board strongly encourages the widespread implementation of these guidelines and is ready to assist users in implementing them.

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Scope

Applies to all health products and technologies, including medicines, vaccines, biologics, and medical devices,submitted for registration in Kenya where reliance pathways are applicable.

Reliance Pathways

• Verification – confirms sameness of a product with one already approved by a reference regulatory authority.
• Abridged Review – relies on full or partial assessment reports from reference regulatory authorities to inform local decisions, evaluating the product under local conditions and regulatory requirements.
• Joint Assessment/Work-sharing – involves collaborative review with other regulators (e.g., AMRH, EAC-MRH, AMA, IGAD, EU-M4ALL, MAGHP).
• Recognition – accepts the regulatory decision of another authority either under mutual recognition agreements or unilaterally.

Recognized Reference Regulatory Authorities (RRAs):

The PPB recognizes and may rely on assessments from:

• World Health Organization (WHO) – Prequalification Programme, Collaborative Registration Procedure.
• Stringent Regulatory Authorities (SRAs) – such as the U.S. FDA, European Medicines Agency (EMA), Health Canada, Swissmedic, PMDA (Japan), TGA (Australia), and others recognized as SRAs.
• Regional Regulatory Mechanisms – including the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative and other African regulatory platforms.

Main Content

• Principles of Reliance – sovereignty, legal basis, transparency, competency, consistency, and universality.
• Health Products Framework – requirements for reliance applications, eligibility criteria for selecting reference authorities, and procedures for variations.
• Medical Devices and IVDs – reliance approaches adapted to device class and public health impact, requirements for reliance applications, eligibility criteria for selecting reference authorities
• Implementation – timelines, documentation standards, and mechanisms for post-approval changes.

Objective

To streamline regulatory processes, avoid duplication, and ensure timely access to safe, effective, and quality-assured health products and technologies in Kenya, while maintaining national regulatory independence. The guideline strengthens PPB’s regulatory capacity, aligns with global best practices, and supports attainment of Universal Health Coverage.

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Regulations governing discipline in the Board and the procedure to be followed in

cases of breach of discipline are contained in this manual.

In addition, an officer is required to comply with the provisions of Chapter Six of the Constitution on Leadership and Integrity and Articles 10 and 232 of the Constitution; Leadership and Integrity Act, 2012; Public Officer Ethics Act, 2003; Anti-corruption and Economic Crimes Act, 2003; Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya, Labour Relations Act, 2007 and the Employment Act, 2007.

Officers are required to adhere to their respective professional codes of conduct. It is imperative that an officer adheres to these rules of conduct, and such other rules which may be introduced from time to time.

All employees shall be required to sign the code of code of conduct upon employment and they will be bound by any amendments to the code of conduct.

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Guidance Overview

The Guideline for Safe Management of Pharmaceutical Waste provides a comprehensive framework for the proper handling, segregation, storage, transportation, treatment, and disposal of pharmaceutical waste in Kenya. Developed by the Pharmacy and Poisons Board (PPB) in collaboration with key stakeholders, the guideline seeks to ensure public health and environmental safety by providing clear processes for managing pharmaceutical waste across the healthcare supply chain.

Purpose and Scope

Purpose:

1. • To establish best practices for the safe management of pharmaceutical waste to protect public health and the environment.
   • To align pharmaceutical waste management in Kenya with international standards, including those set by the World Health Organization (WHO) and the National Environment Management Authority (NEMA).
   • To prevent environmental contamination and public health hazards arising from improper disposal of pharmaceutical waste.

Scope:

• The guideline applies to all pharmaceutical waste generated within Kenya’s healthcare sector, including expired drugs, contaminated materials, substandard or falsified medical products, and unused investigational products.
• It does not apply to other types of healthcare waste, such as sharps, infectious waste, pathological waste, radioactive waste, chemical waste, or general healthcare waste.

Key Features of the Guidance

1. Pharmaceutical Waste Minimization:

1. • Emphasizes strategies to reduce waste, including first-expiry-first-out (FEFO) stock management, refusal of short-dated pharmaceuticals, and returns of expired products to suppliers.

1. Segregation and Packaging:

1. • Details procedures for separating pharmaceutical waste from other healthcare waste.
   • Requires the use of appropriately labeled, leak-proof, and tamper-proof containers for storage and transport.

1. Storage Requirements:

1. • Stipulates that pharmaceutical waste must be stored in clearly marked, secured quarantine areas to prevent accidental use or access by unauthorized persons.
   • Encourages disposal within one year of generation to avoid prolonged storage.

1. Transportation of Pharmaceutical Waste:

1. • Provides requirements for transporting pharmaceutical waste, including vehicle licensing, driver training, and preparation of consignment notes for traceability.

1. Disposal Methods:

1. • Outlines approved methods such as incineration, encapsulation, and inertization to ensure safe and environmentally friendly disposal.
   • Highlights specific handling of hazardous pharmaceuticals, such as cytotoxic drugs, which require high-temperature incineration.

1. Supervision of Disposal:

1. • Mandates that all disposal activities be supervised by the PPB and carried out at NEMA-approved disposal sites.
   • Requires facilities to apply for disposal using prescribed forms and pay applicable supervision fees.

Roles and Responsibilities

1. Pharmacy and Poisons Board (PPB):

• Provides oversight, sensitization, and enforcement of the guideline.
• Issues certificates for pharmaceutical waste disposal and supervises disposal activities.

2. Pharmaceutical Waste Generators:

• Includes manufacturers, healthcare facilities, pharmacies, and distributors.
• Responsible for collecting, recording, segregating, and safely storing waste.
• Must transfer pharmaceutical waste to licensed disposal handlers.

3. Waste Transporters:

• Must be licensed by NEMA and use vehicles equipped with safety and containment features.
• Drivers must be trained in handling pharmaceutical waste and responding to emergencies.

4. Disposal Facility Operators:

• Must comply with PPB and NEMA regulations for waste treatment and disposal.
• Provide proof of safe disposal by issuing certificates of destruction.

5. National Environmental Management Authorities (NEMA):

• Ensure that disposal sites meet environmental safety standards and monitor emissions from incinerators and other treatment facilities.

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What is a Quality Manual?

A Quality Manual is a comprehensive document that outlines the quality management system (QMS) of a laboratory. It serves as a reference for ensuring consistent service delivery, regulatory compliance, and continuous improvement.

Importance of the Quality Manual

• Standardization:Ensures uniform procedures across all laboratory operations.
• Compliance:Supports adherence to national and international quality standards.
• Transparency:Clearly defines roles, responsibilities, and processes.
• Continuous Improvement:Facilitates ongoing development and quality enhancement.

Key Components of the Quality Manual

• Quality Policy:Statement of the laboratory’s quality commitment.
• Organizational Structure:Roles and responsibilities of personnel.
• Standard Operating Procedures (SOPs):Detailed operational guidelines.
• Document Control:Procedures for maintaining updated records.
• Internal Audits:Regular reviews to assess system effectiveness.
• Corrective Actions:Processes for resolving non-conformities.

Roles and Responsibilities

• Management:Provides leadership, resources, and oversight.
• Quality Assurance Team:Monitors and maintains the QMS.
• Laboratory Analyst:Performs testing according to established protocols.
• Clients and Stakeholders:Provide feedback for service improvement.

Quality Management Procedures

1. Policy Development:Define and document quality policies.
2. Personnel Training:Ensure staff competency through continuous training.
3. SOP Implementation:Apply standard procedures in all testing activities.
4. Data Management:Maintain accurate and secure records.
5. Performance Evaluation:Conduct regular audits and performance reviews.
6. Corrective and Preventive Actions:Address issues and prevent recurrence.

Key Challenges in Quality Management

• Resource Limitations:Balancing workload and available resources.
• Compliance Burden:Keeping up with evolving regulatory standards.
• Data Integrity:Ensuring reliability and accuracy of test results.
• Risk Management:Identifying and mitigating potential risks.

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Mamlaka ya Halmashauri  ni kulinda na kukuza afya ya umma kwa kuthibiti taaluma ya dawa na kuhakikisha upatikanaji wa bidhaa na vifaa vya matibabu bora, yenye kuleta matokeo yanayotakiwa na salama.

Halmashauri  inatambua kwamba hati ya huduma kwa mteja ni kiungo muhimu cha utoaji wa huduma kwa wakati na thabiti na ni mkakati muhimu wa kutimiza maono na malengo saidizi.    Zaidi, hati hii ya utoaji wa huduma kwa mteja ni mchakato jumla wa usimamizi utakaotumika katika ngazi zote za shughuli za taasisi.

Wadau na washirika wengine wanatambuliwa wakati wa utoaji wa huduma na kuhakikisha kuna usawa wenye heshima. Usimamizi, kila mara utatambua mahitaji ya mteja, kutathmini na kurekebisha hati ya huduma ili kuhakikisha kuna utoaji wa huduma wa kuridhisha.

Halmashauri  inatoa hakikisho kwa wateja na wadau wa kujitolea kwake kutimiza na kuzidisha matarajio yao. Utekelezaji wa Hati hii ya Utoaji Huduma kwa Mteja kwa hivyo kutaboresha utoaji wa huduma, uwajibikaji huku ikihakikisha mchango wake wa kulinda na kukuza afya ya umma.

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MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD 

Importation of Healthcare Products: Individuals and organizations seeking to import healthcare products, including medicines and medical devices, must comply with the Kenya Pharmacy and Poisons Act and related regulations. The government of Kenya mandates specific requirements, such as temperature and humidity monitoring, import/export authorization permits, and advance notification for certain consignments. Regulated items include: (1) Sample and donated consignments; (2) medicines, including those for personal use; (3) Body parts for transplants and scientific purposes; (4) Finished pharmaceuticals and chemical products; and (5) vaccines and medical devices.

Not only is the importation of expired products strictly prohibited, but the government of Kenya requires that products must still possess at least two-thirds of their original shelf life (i.e., time between the manufactured date and the expiration date) at the time of importation.  All products require market authorization from the Kenya Pharmacy and Poisons Board for legal importation. Non-compliant items are subject to seizure, and importers may face criminal and civil penalties.

Inquiries and applications for import authorizations should be directed to the Kenya Pharmacy and Poisons Board via info@ppb.go.ke or drug_reg@ppb.go.ke.

Location: Local Laws and Special Circumstances: https://travel.state.gov/content/travel/en/international-travel/International-Travel-Country-Information-Pages/Kenya.html

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Scope

This guidance applies to the  drug substances in products submitted for registration in Kenya where  BCS-classification may be considered in the context of bioequivalence study requirements and granting of biowaivers for certain classes of drugs

Main Content

• Biopharmaceutical Classification System– classification of drug substances into four classes:
  • Class I: High solubility, high permeability.
  • Class II: Low solubility, high permeability.
  • Class III: High solubility, low permeability.
  • Class IV: Low solubility, low permeability.
• Listing of drug substances according to the BCS Class.

Objective

This guidance aims to provide a structured framework for classifying drug substances based on solubility and permeability, in line with international regulatory practices.

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