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Pharmacists are required to register and obtain credentials to access Pharmacy and Poisons Board's (PPB) online service portal.
Pharmacists are required to register and obtain credentials to access Pharmacy and Poisons Board's (PPB) online service portal.
Product registration is mandatory for new drugs manufactured in Kenya for export. As the regulator, Pharmacy and Poisons Board (PPB) , will issue a product registration certificate upon successful product evaluation. Prior to issuance of the certificate, traders are also required to obtain a certificate of analysis from a recognized laboratory and a certificate of good manufacturing practices issued by PPB.
A wholesale dealer is an individual who intends to deal with distribution, storage, importation and exportation of medical products. Registration of wholesale dealers must be one by registered pharmacists. As the regulator, Pharmacy and Poisons Board (PPB) will carry out inspection on the premises prior to issuance of the wholesale dealer's licence. The licence issued expires on 31st December in the year of issue.
A certificate of analysis is a document issued after a drug has been analyzed and evaluated by a recognized laboratory in Kenya upon meeting its product specification. For importation and exportation of a new drug; the certificate must be submitted to Pharmacy and Poisons Board (PPB) to facilitate registration of the drug.
In Kenya there are three main labs that perform product analysis which include:
1. Mission for essential Drugs and Supplies ( MEDS)
The Trade Facilitation Platform (TFP) is an electronic system that facilitates the online application, processing, approvals and issuance of export and import permits, and declaration of goods. Training is mandatory for new users of the system prior to registration on the system; this includes new staff from organisations already registered on the system. The TFP is managed by the Kenya Trade Network Agency (KenTrade). For more information on how to register with TFP, click the link.
All pharmaceutical products registered in Kenya must be retained by applying for a product retention certificate which is issued by Pharmacy and Poisons Board (PPB). The certificate issued expires on 31st December every year.
The Import Standardization Mark (ISM) is a mandatory requirement for all imported products intended for sale in the local market. The Kenya Bureau of Standards (KEBS) is the competent Authority that regulates issuance of the ISM stickers. Traders are advised to apply for the ISM sticker once the goods have arrived, and the customs entry has been verified and passed by the Kenya Revenue Authority (KRA).
The following products are exempted from the ISM sticker; medicines, medical devices, pest control products, seeds (plant materials), printed materials, for example, books, newspaper, magazines etc., precious stones, jewellery etc., illuminated signs and name plates etc., motor vehicles and bike (covered under a different inspection regime), artificial flowers, walking sticks, antiques etc., products manufactured in an East African Community (EAC) Partner State, and bears a quality mark of that partner state.