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Wildlife & wildlife products
- Permits per consignment
  - Wildlife & wildlife products export permit
    - Export permit for wildlife & wildlife products (Non-CITES)
    - Export permit for wildlife & wildlife products (CITES)

You are viewing procedures for the

Import

Licit drugs (Dawa za leseni) See associated HS codes

280610 280700 284161 290230 290911 291411 291412 291431 291524 291634 292243 292423 293291 293292 293293 293294 293332 293941 293942 293944 293961 293962 293963

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Preliminary registrations, licences & certificates

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Wholesale dealer's licence

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. Import of licit drugs is regulated by PPB. Registration and application for licences is done on the PPB online service portal. A wholesale dealer is an individual who intends to deal with the distribution, storage, importation & exportation of medical products. Registered pharmacists are required to register wholesale dealers on their behalf with PPB who carry out inspection on the premises prior to issuance of a wholesale dealer's licence. The licence expires on the 31st of December in the year of issue. For more information on how to obtain a wholesale dealer's licence, click the link.

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Import of a drug sample

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. Import of licit drugs is regulated by PPB. Registration and application for licences is done on the PPB online service portal. Prior to the importation of a pharmaceutical product that has not been previously registered in Kenya, importers are required to submit a sample of the drug to PPB and to a recognized laboratory which will issue a certificate of analysis, which is required for product registration. For more information on how to import a drug sample, click the link.

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Certificate of analysis

Prior to the importation of a pharmaceutical product that has not been previously registered in Kenya, importers are required to submit a sample of the drug to PPB and to a recognized laboratory which will issue a certificate of analysis, which is required for product registration. The certificate is issued after a drug has been analyzed & evaluated and has met its product specification. In Kenya there are three (3) main labs that perform product analysis which include:

1. Mission for essential Drugs & Supplies (MEDS)

2. Drug Analysis & Research Unit (DARU)

3. National Quality Control Laboratory (NQCL)

For more information on how to obtain a certificate of analysis, click the link.

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Certificate of good manufacturing practices

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. Import of licit drugs is regulated by PPB. Registration and application for licences is done on the PPB online service portal. Good manufacturing practices are part of the quality assurance that ensures drugs are being produced & controlled as per the quality standards that are appropriate for the end users. Upon the inspection of the manufacturing site by PPB who check for compliance, a certificate of good manufacturing practices is issued. For more information on how to obtain a certificate of good manufacturing practices, click the link.

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Product registration certificate

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. Import of licit drugs is regulated by PPB. Registration and application for licences is done on the PPB online service portal. Product registration is mandatory for all drugs imported into Kenya. PPB issues a product registration certificate upon successful product evaluation. For more information on how to obtain a product registration certificate, click the link.

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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.

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Licences & certificates renewals

Wholesale dealer's licence & certificate of premise registration

A wholesale dealer is an individual who intends to deal with the distribution, storage, importation & exportation of medical products. Registered pharmacists are required to register wholesale dealers on their behalf with the Pharmacy & Poisons Board (PPB) who carry out inspection on the premises prior to issuance of a wholesale dealer's licence. The licence expires on the 31st of December in the year of issue. Applications for renewals are required to be submitted not later the 31st of December each year. For more information on how to obtain a renewal of a wholesale dealer's licence & certificate of registration, click the link.

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Product retention certificate

Product registration is mandatory for all drugs imported into Kenya. The Pharmacy & Poisons Board (PPB) issues a product registration certificate upon successful product evaluation. All medical & pharmaceutical products registered in Kenya are required to be retained by obtaining a product retention certificate which expires on the 31st of December every year. For more information on how to obtain a product retention certificate, click the link.

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Permits

Certificate of radioanalysis

The Kenya Nuclear Regulatory Authority (KNRA) is a public entity established to provide radiation protection, nuclear safety, nuclear security, nuclear safeguards, and the protection of persons, property and the environment against the harmful effects of ionizing & non-ionizing radiation through the establishment of a system of regulatory control. For more information on how to obtain a certificate of radioanalysis for consignments imported through the Jomo Kenyatta International Airport (JKIA), the Inland Container Depot, Nairobi (ICDN), or the Port of Mombasa, select from the options below.

Import Declaration Form (IDF)

The Import Declaration Form (IDF) is a declaration of the customs value of a consignment, and is issued by the Kenya Revenue Authority’s (KRA), Customs Services Department. Importers are required to complete an IDF and sign it to show that they have declared the true & accurate value of the imported goods before they leave the country of origin. IDFs that remain unutilized after three (3) months from the date of issuance will automatically attract the appropriate sanctions. For more information on how to obtain an IDF, click the link.

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Commercial medicines import permit

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. Import of licit drugs is regulated by PPB. Import of licit drugs is regulated by PPB who will issue a commercial medicines import permit per consignment. Prior to issuance of the permit, importers must obtain an import authorization & certificate of approval of import from PPB in compliance with the Narcotics & Psychotropic substances Regulations. The permit is processed through the Trade Facilitation Platform (TFP). For more information on how to obtain a commercial medicines import permit, click the link.

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Local Certificate of Conformity (CoC) (only applies to consignments that arrive without a CoC)

A Certificate of Conformity (CoC) is a certified document issued by the Kenya Bureau of Standards (KEBS), which assures that commodities have met the required standards & specifications. When a consignment arrives in Kenya without a CoC, indicating that the consignment was inspected at the country of origin, an importer is required to obtain a local CoC. The certificate is only issued after successful inspection & verification of the consignment is carried out by KEBS. For more information on how to obtain a local CoC, click the link.

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Import Standardization Mark (ISM) permit (only applies to consignments for sale in the local market)

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 & bikes (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.

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Clearance

Licit drugs import procedure through the Jomo Kenyatta International Airport (JKIA)

In accordance with the provisions of the East African Community Customs Management Act (EACCMA), goods for importation shall be entered (declared) within twenty-one (21) days after the commencement of discharge or in the case of vehicles, on arrival. Importers are required to acquire the services of a licensed customs clearing agent, who is mandated to process the importation documents in the Customs system and assist in clearing goods on the importer’s behalf. For more information on how to import a consignment of licit drugs through JKIA, click the link.

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Procedures for a first-time trader

Licit drugs import procedure through Jomo Kenyatta International Airport (JKIA)

This procedure sequentially compiles the licences, permits and clearance steps to be fulfilled by a registered business owner importing a consignment of licit drugs, of more than $2000 of value, through Jomo Kenyatta International Airport (JKIA).

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