Publications - Pharmacy and Poisons Board

November 2025 Exams

ppb_admin — Tue, 16 Sep 2025 05:23:29 +0000

The Pharmacy and Poisons Board will conduct the Pre-registration Exams (Stage I & II) and Enrolment exams (Level I & II) on November 17^t^h, 18^th, 19^th, and 20^th, 2025.

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Pharmacovigilance Summary Report: October 1st to December 31st 2024 (Q2)

ppb_admin — Tue, 11 Feb 2025 17:19:58 +0000

In Quarter 2 (from October 1 to December 31, 2024), the National Pharmacovigilance Centre received 278 reports of suspected adverse drug reactions (SADRs). Among these, 271 reports (97.48%) were initial reports and 7 reports (2.52%) were follow-up reports. To avoid duplication, only one copy of each Individual Case Safety Report (ICSR) was included in the analysis, resulting in a total of 271 reports for this quarterly summary. All 271 initial reports pertained to suspected adverse drug reactions (SADRs).

The post Pharmacovigilance Summary Report: October 1st to December 31st 2024 (Q2) first appeared on Pharmacy and Poisons Board.

Verbiage Immigration

ppb_admin — Mon, 16 Dec 2024 07:43:23 +0000

REPUBLIC OF KENYA

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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Promoting Safe and Reliable Healthcare Through Good Distribution Practices

Public Relations — Wed, 04 Dec 2024 13:24:43 +0000

The post Promoting Safe and Reliable Healthcare Through Good Distribution Practices first appeared on Pharmacy and Poisons Board.

NOTIFICATION ON RENEWALS OF MEDICINES AND VACCINES

Tony Kemboi — Tue, 03 Dec 2024 21:32:48 +0000

In accordance with Rule 10 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, the Board would like to notify all Marketing Authorization Holders (MAH’s) on the expiry of the validity of the certificates of registration for medicines and vaccines issued in the year 2019.

The post NOTIFICATION ON RENEWALS OF MEDICINES AND VACCINES first appeared on Pharmacy and Poisons Board.

Notice is given on the Renewal of Reregistration of Medical Devices Including In-Vitro Diagnostics

Tony Kemboi — Tue, 03 Dec 2024 21:29:48 +0000

The Pharmacy and Poisons Board (“the Board”), is empowered under Section 3A(c) of the Pharmacy and Poisons Act, Chapter 244 Laws of Kenya, to grant or withdraw marketing authorization for Medical Devices including In-Vitro Diagnostics subject to appropriate conditions. In line with this mandate, in order to ensure continued quality, safety and performance of registered medical Devices including In-Vitro Diagnostics, the Board grants certificates of registration with a limited validity period of five (5) years from the date of issue, subject to the requirement of annual retention in the register and renewal of registration.

In light of the above, all Marketing Authorization Holders (MAHs) are hereby notified of the obligation to initiate the renewal process for products that are approaching or have exceeded their validity period in accordance with Rule 9 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022. Therefore, MAHs are guided as follows:

a)For MDs/IVDs granted marketing authorization (MA) in 2020, submit renewal applications at least two (2) months prior to expiration of the MA;
b)For MDs/IVDs initially authorized in 2018 and 2019, ensure re-registration is completed no later than 1^st January 2026.

For more details on implementation of the re-registration requirements, kindly access the Guidelines on Registration of Medical devices including In-Vitro Diagnostics (HPT/PER/GUD/011) on our website web.pharmacyboardkenya.org. Additionally, you may contact the Board through phone number, +254 709 770 100, for any inquiries or clarifications.

Your cooperation is appreciated.

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PPB Public Awareness Posters

Public Relations — Wed, 13 Nov 2024 19:52:59 +0000

The post PPB Public Awareness Posters first appeared on Pharmacy and Poisons Board.

Quality Policy

Tony Kemboi — Mon, 11 Nov 2024 21:32:00 +0000

The Pharmacy and Poisons Board (PPB) aims at being a global leader in promoting and protecting public health through regulating the profession of pharmacy and ensuring access to quality, safe, efficacious and affordable health products and technologies. The Board’s strategic direction is to improve access through leveraging on research and technological innovation which translate into real-world solution for diagnostics, treatments, and cures.

Our commitment is to maintain and continually improve a quality management system and ensure customer satisfaction based on ISO 9001:2015, customer, statutory and regulatory requirements and emerging trends in the pharmaceutical sector.

Quality objectives have been established at corporate and functional levels in line with the strategic plan and international best practices. This quality policy and objectives shall be communicated to all staff, made available to relevant interested parties and reviewed periodically for continuing suitability.

The post Quality Policy first appeared on Pharmacy and Poisons Board.

Pharmacovigilance Summary Report: July 1st to Sept 30th 2024 (Q1)

Tony Kemboi — Mon, 11 Nov 2024 21:08:34 +0000

The Pharmacy and Poisons Board is the National Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board regulates the Practice of Pharmacy and the manufacture and trade of drugs and poisons. The PPB has 4 directorates of which the Department of Product Safety (PDS) under the Health Product and Technologies Directorate is responsible for Pharmacovigilance, Post- Marketing Surveillance, Clinical Trials & Medicines Information activities. PDS shares quarterly pharmacovigilance reports with stakeholders to serve as a feedback mechanism and also encourage all stakeholders to report adverse events. Since the introduction of PV in Kenya, a total of 19,754 individual case safety reports (ICSRs) have been submitted to the global database representing 2.7% of the total ICSRs submitted by African countries.

The post Pharmacovigilance Summary Report: July 1st to Sept 30th 2024 (Q1) first appeared on Pharmacy and Poisons Board.

Protected: Completing The AEFI Reporting Form (Click the download button to watch )

ppb_admin — Tue, 06 Aug 2024 12:34:01 +0000

The post Protected: Completing The AEFI Reporting Form (Click the download button to watch ) first appeared on Pharmacy and Poisons Board.