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1.
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Notifying
Member: KENYA
If applicable, name of local government involved (Articles 3.2 and 7.2):
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2.
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Agency
responsible:
Pharmacy and
Poisons Board (PPB)
Pharmacy
& Poisons Board Hse
Lenana Road
P.O. Box
27663-00506
NAIROBI.
Telephone:
0709770100
Email: info@ppb.go.ke; tradeaffairs@ppb.go.ke
Website:
www.pharmacyboardkenya.org
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3.
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Notified
under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:
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4.
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Products covered (HS codes or national tariff lines. ICS numbers may
be provided in addition, where applicable): Pharmaceutical
preparations and products of subheadings 3006.10.10 to 3006.93.00 (HS
code(s): 3006); Pharmaceutics (ICS code(s): 11.120)
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5.
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Details of notified document(s) (title,
number of pages and languages, means of access): Authentication and
Traceability Standard (A&T) of Health Products and Technologies (HPTs),
Version 0, 2025; (46 page(s), in English)
Link to notified document(s) and/or contact
details for agency or authority which can provide copies upon request:
Text - https://web.pharmacyboardkenya.org/download/standards-for-authentication-and-traceability-of-health-products-and-technologies/
Comments Template - https://web.pharmacyboardkenya.org/download/track-and-trace-standards-stakeholder-comments-template/
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6.
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Description
of content: This document provides
a comprehensive framework for the implementation of Authentication and Traceability (A&T) standards
for Health Products and Technologies (HPTs) in Kenya. It aims to safeguard patient safety, ensure product integrity, and secure the medical supply chain from falsified and
substandard products.
The standard
applies to all stakeholders involved in
the supply chain of regulated medical products—from manufacturers to pharmacists—including
importers, distributors, wholesalers, healthcare providers, and A&T
service providers. It covers therapeutic
and non-therapeutic products, such as: Oral and non-oral
medications, Herbal medicines, Medical devices and diagnostics, Cosmetic
products with medical claims.
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: Prevention of deceptive practices and consumer protection;
Protection of human health or safety; Quality requirements
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8.
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Relevant
documents:
1._
Global
Standards Organization (GS1)
2._
ISO 23023
(track and trace for medical devices)
3._
ISO 17971 (risk
management for medical devices)
4._
Policy paper on
traceability of medical products. Geneva: World Health Organization; 2021.
Licence: CC BY-NC-SA 3.0 IGO
5._
5. EU. -
DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June
2011 amending Directive 2001/83/EC on the Community code relating to
medicinal products for human use
6._
6. U.S. - Drug
Quality and Security Act. 21 USC 301 - Public Law 113–54
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9.
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Proposed
date of adoption: 30 May 2026
Proposed date of entry into force: To be determined
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10.
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Provision of comments
Final
date for comments: 10 December 2025
[ ] 60 days from notification
Contact details of agency or authority designated to handle comments
regarding the notification:
Kenya Bureau
of Standards (KEBS)
KEBS Centre
Contact
Person: Managing Director
Popo Road,
off Mombasa Road, Behind Bellevue Cinema
P.O. Box 54974
Nairobi 00200
Tel: +(254) 722 202137; +(254) 724 255242
Fax: +(254) 20 609660; +(254) 20 604031
Email: info@kebs.org
Website: https://www.kebs.org
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