THE KENYA HEALTH PRODUCTS AND TECHNOLOGIES REGULATORY AUTHORITY BILL, 2022
Status Timeline
Proposed
Active now
Public Review
Pending
Debate
Pending
Executive
Pending
Final
Pending
New Regulatory Authority Established
Establishes the Kenya Health Products and Technologies Regulatory Authority under Section 4 to inspect, register, and regulate health products, medical devices, and cosmetics.
Strict Licensing and Registration Rules
Prohibits the manufacture, sale, or distribution of unregistered health products under Section 21. Violations carry a fine of up to KSh 1 million or 3 months imprisonment for first offences, and up to KSh 2 million or 5 years imprisonment for subsequent offences.
Regulation of Scheduled Substances
Restricts the possession of scheduled substances under Section 42 to licensed wholesale dealers, pharmacists, and medical practitioners. Unlawful possession carries a fine of up to KSh 2 million or up to 3 years imprisonment.
Transition and Repeal of Cap. 244
Repeals the Pharmacy and Poisons Act (Cap. 244) and outlines transitional provisions under Section 99 to transfer all assets, liabilities, and staff from the former board to the new Authority.
Bill No.
N.A. /B/No. 54/2022
Gazette No.
Supplement No. 184 of 2022
Background
The Kenya Health Products and Technologies Regulatory Authority Bill, 2022 seeks to establish a comprehensive legal framework for the regulation of health products and technologies in Kenya. The legislation is designed to safeguard public health by ensuring the safety, quality, efficacy, and performance of medicines, medical devices, cosmetics, and scheduled substances.
Key Amendments
- Repeals Cap. 244: The Bill repeals the Pharmacy and Poisons Act (Cap. 244) in its entirety (Section 100).
- Amends Cap. 247: Amends the Narcotic Drugs and Psychotropic Substances (Control) Act (Cap. 247) by repealing Sections 16, 17, and 18 (Fifth Schedule).
- Establishes National Quality Control Laboratory: Establishes a dedicated laboratory under Section 67 to conduct chemical, biological, and biopharmaceutical analysis of health products.
New Obligations
- Product Registration: Any person intending to import, manufacture, or sell a health product or technology must apply for registration in the prescribed form under Section 26.
- Manufacturing Licences: Manufacturers must obtain a license from the Authority and comply with good manufacturing practices prescribed under Section 51.
- Wholesale and Distribution: Wholesale dealers must hold a valid Wholesale Dealer's Licence (Section 43) and maintain a Scheduled Substances Book (Section 45) to record sales.
- Medical Device Establishments: Establishments dealing in medical devices must be registered under Section 65.
Penalties
- Sale of Unregistered Products: Selling unregistered, adulterated, or substandard health products is an offence under Section 21, carrying a fine of up to KSh 1 million or 3 months imprisonment for a first offence, and KSh 2 million or 5 years imprisonment for subsequent offences.
- Unauthorised Possession of Scheduled Substances: Possession of scheduled substances outside the specified exemptions is punishable under Section 42 by a fine of up to KSh 2 million, imprisonment for up to 3 years, or both.
- Deception and Falsification: Falsifying or misrepresenting health products, cosmetics, or medical devices carries a fine of up to KSh 2 million or imprisonment up to 3 years for a first offence (Sections 22, 62).
Transitional Provisions
- Asset and Staff Transfer: Section 99 dissolves the former Board and transfers all assets, liabilities, and ongoing agreements to the newly established Authority. Former staff are deemed to be staff of the new Authority.
- Winding Down Period: The Pharmacy and Poisons Board will continue to exist for up to 24 months from the commencement date to oversee the transition of pharmacy practice regulation (Section 99(3)).
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