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Medical professionals dealing with medical products are required to register and obtain credentials to access Pharmacy and Poisons Board's (PPB) online service portal. For more information on how to obtain the credentials, click the link.
The Pharmacy & Poisons Board (PPB) is the drug regulatory authority that regulates the practice of pharmacy, and the manufacture & trade in drugs and poisons. PPB aims to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy & quality for all drugs, chemical substances & medical devices, locally manufactured, imported, exported, distributed, sold, or used, to ensure the protection of the consumer as envisaged by the laws regulating drugs in force in Kenya. Export of food supplements is regulated by PPB. Registration and application for licences is done on the PPB online service portal. For more information on how to register on the PPB online service portal, click the link.
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.
For a local manufacturer who intends to manufacture drugs for export, the manufacturer must obtain a certificate of good manufacturing practices which is issued after the manufacturing site has been inspected by inspectors from Pharmacy and Poisons Board to ensure that they have complied with the set good manufacturing practices.
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 Kenya Trade Network Agency (KenTrade) is a State Corporation mandated to establish, implement & manage the Trade Facilitation Platform (TFP), and to facilitate trade. The TFP is an online platform that serves as a single entry point for parties involved in international trade & transport logistics to lodge documents electronically, for processing, approvals and to make payments electronically for fees, levies, duties & taxes due to the Government, on imported or exported goods. Training is mandatory for new users of the system prior to registration on the system; this includes new staff from organizations already registered on the TFP. For more information on how to register on the TFP, click the link.
This procedure applies to first time traders who require to obtain a preferential certificate of origin during export. Traders are required to register with the Kenya Revenue Authority’s (KRA) Rules of Origin Section to obtain a registration letter. The letter confirms the country of origin of the goods to be exported and is a requirement when applying for the preferential certificate of origin.
The Kenya National Chamber of Commerce & Industry (KNCCI) is the umbrella body of the private sector in Kenya. The Chamber is an autonomous, non-profit, membership-based & private sector lobby institution. Membership to the Chamber is not mandatory however, membership is diverse and has benefits such as networking opportunities, training consultancy, customer referrals & credibility in your business to mention a few. For more information on how to register with KNCCI, click the link.
A food hygiene licence is required for all facilities that process and package products that are for human consumption, e.g packhouses. The licence is issued by Port Health Services Kenya (PHS) or by Public Health Officers, from the respective County Governments where the premises are located. The licence is valid for one (1) calendar year. For more information on how to obtain a food hygiene licence from either the County Government or County Public Health Office, select from the options below.
Export of pharmaceutical products is regulated by Pharmacy and Poisons Board (PPB) who issues an export permit for each consignment. The export permits are processed through the Trade Facilitation Platform (TFP).
The AfCFTA certificate of origin is an international trade document which certifies that a certain product being exported is wholly manufactured, produced, processed or obtained from the exporting country. COO is issued by the Kenya Revenue Authority (KRA), Rules of Origin Section. For more information on how to obtain the certificate, click the link.
The European Union (EU) certificate of origin is required for goods obtained, manufactured, produced or processed in Kenya, and are to be exported within the European community. The certificate is issued per consignment. For more information on how to obtain the certificate, click the link.
The COMESA certificate of origin is required for goods obtained, manufactured, produced or processed in Kenya, and are to be exported within the Common Market for Eastern and Southern Africa (COMESA) region. The certificate is issued per consignment. For more information on how to obtain the certificate, click the link.
The Generalised System of Preferences (GSP) certificate of origin is required for goods obtained, manufactured, produced or processed in Kenya, and are to be exported to a member state. The certificate is issued per consignment. For more information on how to obtain the certificate, click the link.
The EAC certificate of origin is required for goods obtained, manufactured, produced or processed in Kenya, and are to be exported within the East African Community (EAC) region. The certificate is issued per consignment. For more information on how to obtain the certificate, click the link.
The African Growth & Opportunity Act (AGOA) certificate of origin is required for goods obtained, manufactured, produced or processed in Kenya, and are to be exported to a country within the AGOA trade Act. The certificate is issued per consignment. For more information on how to obtain the certificate, click the link.
The Kenya National Chamber of Commerce and Industry (KNCCI) has the mandate to issue the (ordinary/non-preferential) Certificate of Origin (COO) to all exporters of goods originating from Kenya. For more information on how to obtain the certificate, click the link.
Export of medical products is regulated by Pharmacy and Poisons Board (PPB) who issue product registration certificates for all new products, licences & certificates, and export permits per consignment. For more information on how to clear your consignment of medical products through Jomo Kenyatta International Airport (JKIA), click on the link.