InfoTradeKenya

Welcome to Kenya's Trade Information Portal More information

Official Kenya Government website

A .go.ke website belongs to an official government organization in Kenya. The Kenya Trade Information Portal is managed by the Kenya Trade Network Agency (KenTrade)

Secure .go.ke websites use HTTPS

A lock ( ) or https:// means you're safely connected to the .go.ke website.

Share sensitive information only on official, secure websites.

Search by

Search all

Inquiry

You are viewing procedures for the

Import

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

Understand how we structure the search results and procedures

Preliminary registrations, licences & certificates

Pharmacists are required to register and obtain credentials to access Pharmacy and Poisons Board's (PPB) online service portal.

View procedure

Pharmacists are required to register and obtain credentials to access Pharmacy and Poisons Board's (PPB) online service portal.

View procedure

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.

View procedure

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.

View procedure

Product registration certificate (for food supplements)

Product registration is mandatory for all food supplements 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 good manufacturing practices issued by PPB.

View procedure

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.

View procedure

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)

View procedure

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.

Licences and certificates renewal

Permits

Import declaration form (IDF)

All importers are required to obtain an import declaration form (IDF) for each consignment prior to importation of any commodity. 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.

View procedure

Import permit for pharmaceutical products

Import of pharmaceutical products is regulated by Pharmacy and Poisons Board (PPB) who also issues an import permit for each consignment. The import permits are processed through the Trade Facilitation Platform (TFP).

View procedure

Import licence for radioactive devices

The Kenya Nuclear Regulatory Authority (KNRA) is mandated to provide protection of persons, property and the environment against the harmful effects of ionizing and non-ionizing radiation through the establishment of a system of regulatory control. Prior to importation of radioactive devices and/or sources, importers must obtain an import licence from KNRA. For more information on how to obtain the licence, click the link.

View procedure

Local certificate of conformity (COC)

A certificate of compliance is a certified document issued by the Kenya Bureau of Standards (KEBS), which assures that commodities have met the required standards and specifications. When a consignment arrives in Kenya without a certificate of conformity, indicating that the consignment was inspected at the country of origin, an importer will have to obtain a certificate of compliance. The certificate is only issued after successful inspection and verification of the consignment is carried out by KEBS.

View procedure

Import standardization mark (ISM)

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.

View procedure

Import declaration form (IDF)

All importers are required to obtain an import declaration form (IDF) for each consignment prior to importation of any commodity. Before applying for the IDF, traders are advised to obtain the relevant 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.

View procedure

Certificate of radioanalysis