InfoTradeKenya

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Export

Medical products (Bidhaa za matibabu) See associated HS codes

300120 300190 300211 300212 300213 300214 300215 300219 300220 300230 300290 300310 300320 300331 300339 300341 300342 300343 300349 300360 300390 300410 300420 300431 300432 300439 300441 300442 300443 300449 300450 300460 300490 300510 300590 300610 300620 300630 300640 300650 300660 300670 300691 300692

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Preliminary registrations, licences & certificates

Medical professionals dealing with medical products, devices, food supplements, cosmetics, Non Profit Organizations and development partners products are required to register and obtain credentials to access PPB's online service portal. For more information on how to register as a pharmacist or medical professional, select from the options below.

Product registration certificate

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.

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Wholesale dealer's licence

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.

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Certificate of good manufacturing practices

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.

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Certificate of analysis

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)

2. Drug Analysis and Research unit (DARU)

3. National Quality Control Laboratory (NQCL)

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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 and 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 and credibility in your business to mention a few.

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Train & register on the Trade Facilitation Platform (TFP)

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. Traders are required to be trained and then registered on the TFP as users of the system. The TFP is managed by the Kenya Trade Network Agency (KenTrade). For more information on how to train and register on the TFP, select from the options below

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.

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Food hygiene licence

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.

Licences and certificates renewal

Permits

Export permit for pharmaceutical products

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).

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Standardization mark permit

The Standardization Mark (S Mark) is a mandatory mark of quality required for goods that are processed and packaged locally intended for local consumption or for export within the East African Community (EAC) region. Traders wishing to export processed goods within the EAC region are therefore required to obtain an S Mark permit which is issued by the Kenya Bureau of Standards (KEBS). The permit is valid for one (1) calendar year from the date of issue.

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Certificate of radioanalysis

The Kenya Nuclear Regulatory Authority (KNRA) is the Authority that regulates all radioactive materials, materials that contain radioactive elements and equipment that produce radioactive waves in Kenya. As the regulator, KNRA issues the certificate of radio analysis to ascertain that commodities are free of radioactive elements. For more information on how to obtain the certificate, select from the options below and click the link.

Certificate of origin

The Certificate of Origin (COO) is an international trade document which certifies that, a certain product being exported is wholly manufactured, produced, processed or obtained from the exporting country. For more information on how to obtain the COO, please select from the options below.

Non-preferential certificate of origin

A non-preferential certificate of origin is an export document issued by the Kenya National Chamber of Commerce and Industry (KNCCI) that confirms the country of origin of goods being exported. The AfCFTA certificate of origin is issued by the Kenya Revenue Authority (KRA), Rules of Origin Section. For more information on how to obtain a non-preferential certificate of origin, select from the options below.

Preferential certificate of origin

Clearance

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Procedures for a first-time trader

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Export pharmaceutical products through Lunga Lunga One Stop Border Post (OSBP)

This procedure sequentially compiles the licences, permits and clearance steps to be fulfilled by a registered business owner exporting a consignment of pharmaceutical products, of more than $2000 of value, for the first time out of Kenya, via the Lunga Lunga OSBP.

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Export pharmaceutical products through Jomo Kenyatta International Airport (JKIA)

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Export pharmaceutical products through the Namanga One Stop Border Post (OSBP)

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Export pharmaceutical products through Isebania One Stop Border Post (OSBP)

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Export pharmaceutical products through Malaba One Stop Border Post (OSBP)

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Export pharmaceutical products through Eldoret International Airport (EIA)

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Export pharmaceutical products through the Port of Mombasa