Market Surveillance and Control
The Market Surveillance and Control (MC) function plays a crucial role in assuring the safety of medical product consumers. Its main objective is to ensure that products on the Kenyan market comply with pre-set standards of quality, safety, and efficacy, in line with their marketing authorization and good practices guidelines.
PPB’s Market Control activities focus on:
- Control of import and export activities
- Prevention, detection, and response to substandard and falsified (SF) products
- Market surveillance of product quality across the supply chain
- Oversight of promotional, marketing, and advertising practices
Our Role
- Monitor the quality of medicines and health technologies once they are on the market.
- Detect and address substandard and falsified (SF) products.
- Protect public health through timely regulatory actions including recalls, alerts, and withdrawals.
How We Work
- Risk-based approach: Active PMS (complaint handling, poor-quality reports) and Proactive PMS (planned product quality surveys).
- Laboratory testing: Products are sampled and tested in accredited labs.
- Collaboration: We work with healthcare providers, manufacturers, importers, law enforcement, and the public.
- Transparency: PMS survey results and regulatory actions are published for stakeholders.
Reporting Suspected Products
If you encounter a suspected poor-quality, unsafe, or falsified medical product, report it through:
- PvERS online system ( https://pv.pharmacyboardkenya.org/ )
- Email: pms@ppb.go.ke
- Phone: +254 795 743 049
The Pharmacy and Poisons Board (PPB), under Section 3B of the Act, regulates the import and export of medicinal products to ensure they meet prescribed standards of quality, safety, and efficacy.
Additionally, Section 3B (h) empowers the Board to oversee the licit use of narcotics, psychotropic substances, and precursor chemicals in compliance with:
- The Single Convention on Narcotic Drugs (1961)
- The Convention on Psychotropic Substances (1971)
- The UN Convention Against Illicit Trafficking of Narcotic Drugs and Psychotropic Substances (1988)
This function is implemented through the Trade Affairs Unit.
We also engage in:
- Trade policy formulation and implementation
- Addressing Specific Trade Concerns (STCs)
- Addressing technical barriers to trade
- Participating in bilateral and multilateral engagements with other government agencies
How We Work
To streamline operations, the Unit has embraced an online system for submission and evaluation of import and export permits.
Contact Information
Tel: +254 709 770 511
Email: tradeaffairs@ppb.go.ke
The Medicines Information (MI) function of the Pharmacy and Poisons Board reviews, monitors, and ensures that information provided to healthcare professionals, policy makers, and the public is accurate, timely, and evidence based. It responds to inquiries on product safety, quality, efficacy, and registration status, maintains accessible public registers and alerts, and promotes the ethical promotion and advertising of medicines. By supporting the rational use of medicines and strengthening transparency, MI contributes to informed decision-making and improved patient safety.
To achieve its objectives within the Market Surveillance and Control (MSC) function, the MIU collaborates with key departments including Post-Market Surveillance (PMS), Ports of Entry (POE), and the Trade Affairs Unit.
Core Function
The MIU is responsible for reviewing and approving promotional materials; providing accurate and up-to-date medicine information; supporting post-market surveillance through the review of complaints and investigations related to misleading claims, unauthorized promotions, or non-compliant advertising; offering regulatory guidance to stakeholders; and collaborating across regulatory functions to ensure that health products in Kenya are safe, effective, and truthfully represented.
📞 Contact Information
Email: mi@ppb.go.ke
The Pharmacy and Poisons Board (PPB), under Section 3B(d) of the Pharmacy and Poisons Act, is mandated to enforce standards of quality, safety, and efficacy for all medicinal substances manufactured, imported, or exported through Kenya’s ports of entry (POEs). The POE ensures compliance with Good Distribution Practices by inspecting and verifying consignments of health products and technologies before approving release or denying entry to safeguard public health.
Our Role:
- Verification of import and export documents for Health Products and Technologies (HPTs)
- Pre-clearance inspection of health products, laboratory reagents, precursor substances, and cosmetics
- Investigation, detection and prevention of illicit trade practices of HPTs
- Routine sampling of HPTs for testing
- Approving consignments for release or denial of entry
How we work:
- PPB initiated inspection and verification approach
- Risk based inspection approach
- Multiagency Joint verification and collaboration approach
- Joint border patrols
- Monitoring of imports and Surveillance activities at the border points
Gazetted Ports of Entry
Health products and technologies are expected to be imported through designated and gazetted ports namely:
- Airports: JKIA and Eldoret International
- Seaports: Kilindini (Mombasa), Inland Container Depot-Embakasi
- Dry Land Ports: Busia, Malaba, Isibania, Namanga and Lunga Lunga One Stop Border Points (OSBPs)
- Post Offices & Courier Services: City Square (Nairobi), Express Mail Service (EMS) & General Post Office (GPO) Nairobi
For enquiries, please contact us through:
- Email: poe@ppb.go.ke , jkia@ppb.go.ke
- Phone: +254 795 743 049,
Kilindini: +254 702475695
Resources
- Guideline for Management of Narcotics, Psychotropics, and Precursor Chemical Substances
- National Guideline for Medically Assisted Therapy (MAT) Pharmacies in Kenya
- Pharmacy and Poisons Act (Cap. 244)- Section 3B(g)