PRODUCT REGISTRATION
REGISRATION INFORMATION
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The Pharmacy and Poisons Board is empowered by law to regulate and control the manufacture, importation, exportation, advertisement, distribution and sale of regulated goods like drugs, food and dietary supplements, chemical substances and medical devices in Kenya.
Muthoni Advocates’ services include full registration of products in both categories, as currently set out by the Pharmacy and Poisons Board : drugs and food.
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Drugs include medical devices, vaccines, chemicals and pesticides, veterinary products, nutraceuticals and supplements, herbal preparations and cosmetics.
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Food products include processed and semi-processed food, bottled or sachet water, alcoholic and non-alcoholic drinks, etc.
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Requirements for procurement of samples:
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During the registration process, the Board will require samples of the product. therefore grants special authorization to import such samples if manufactured outside Kenya.
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Documents for clearing and taking delivery of samples must be submitted to the Pharmacy and Poisons Board
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Certificate of Analysis issued by the manufacturer
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Certificate of Manufacture and Free Sale issued by the appropriate regulatory authority in the country of origin
How long does the full registration procedure take?
Product registration can be divided into two stages and although the required documentation varies for different drug and food categories, the general procedure is similar.
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Stage one: One month - applying and obtaining approval to import samples (not applicable if the product is locally manufactured), for procurement and completion of the application for each product.
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Stage two: Two months - Issuance of the Pharmacy and Poisons Board registration number.
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To work within the time frame, all required documents must be submitted by the applicant when filing the application.​
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