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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.
Product registration certificate (for herbal medicine) Product registration is mandatory for herbal medicines imported into Kenya. Pharmacy and Poisons Board (PPB) is the mandated authority to issue traders with a product registration certificate upon successful product evaluation. Prior to issuance of the certificate, the trader is also required to have obtained 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:
Wholesale dealer's licence (renewal)A wholesale dealer's licence is a mandatory requirement for a trader who intends to deal with distribution, storage, importation and exportation of medical products. The licence is only issued to registered pharmacists as regulated by the Pharmacy and Poisons Board (PPB). The licence expires on 31st December in the year of issue.
Traders are required to lodge applications for renewals not later than 31st December every year.
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.
All importers are required to obtain an import declaration form (IDF) for each consignment prior to importation of any commodity. Import declaration forms are processed through the Kenya National TradeNet System (KESWS). Applications can either be made by the importer or the clearing agent appointed by the importer.
An import health certificate is required for the import of all commodities that are for human consumption. Issuance of the certificate is regulated by Port Health Services and is required for each consignment.
Before applying for the IDF, traders are advised to obtain permits/get a go ahead from the respective regulating Agencies for the consignment of import. Also, application for the IDF should be done before goods leave the country of origin.
Full procedure view - for a first time trader
Pharmaceutical products import procedure through JKIAThis procedure sequentially compiles the licences, permits and clearance steps to be fulfilled by a registered business owner importing a consignment of pharmaceutical products, of more than $2000 of value, through Jomo Kenyatta International Airport (JKIA).