Strong pain medicines such as morphine, oxycodone and fentanyl, and many sedatives and anaesthetics, are essential to Kenyan healthcare and in chronically short supply. They are also among the most tightly controlled goods anyone can trade. Importing narcotic and psychotropic medicines into Kenya requires three separate layers of authority: a business licence to deal in medicines, registration of each product, and a specific licence and authorisation under the Narcotic Drugs and Psychotropic Substances (Control) Act (Cap. 245). This guide explains how those layers fit together and why getting any one of them wrong carries some of the heaviest penalties in Kenyan law.
Unlicensed Importation Is Trafficking
The starting point is the definition of “trafficking” in section 2 of Cap. 245. It covers the importation, exportation, manufacture, sale, supply, storage, conveyance and distribution of any narcotic drug or psychotropic substance. The definition excludes importation or exportation by or on behalf of a person who holds a licence under the Act, provided it is done in accordance with that licence. It also excludes supply for medicinal purposes by medical practitioners and by registered pharmacists acting within the Act.
The practical effect is stark. A company that imports a controlled medicine without the correct licence, or outside the terms of its licence, is not committing a regulatory breach. It is trafficking. Section 4 of the Act, as consolidated on Kenya Law, sets penalties for trafficking in narcotic drugs or psychotropic substances that include fines of not less than thirty million shillings and imprisonment for thirty years, rising to fifty years where more than 100 grams is involved. Medicinal intent is not a defence to an unlicensed import.
Who Issues the Licence
Section 16 of Cap. 245 requires the Cabinet Secretary to establish a Board, made up of representatives of the Attorney-General, the ministries responsible for internal security and for health, the Inspector General of Police and three appointed members. That Board issues licences for the importation, exportation, sale, manufacture and distribution of narcotic drugs and psychotropic substances, names the ports through which they may enter or leave Kenya, and prescribes the records that importers and distributors must keep.
In practice, applications for import and export authorisations for controlled medicines are processed by the Pharmacy and Poisons Board (PPB). The PPB moved this process online in 2019 using the National Drug Control System developed by the United Nations Office on Drugs and Crime. Anyone planning to trade in these products should confirm the current application route with the PPB before relying on any published procedure.
Each Consignment Needs Its Own Authorisation
Kenya is a party to the international drug control treaties, which operate a closed trading system. Under the 1961 Single Convention, each country submits annual estimates of its medical and scientific requirements for narcotic drugs to the International Narcotics Control Board (INCB). The confirmed estimates set the maximum quantity a country may acquire through import or manufacture in a year.
Two consequences follow for importers:
- Authorisation is per shipment. A licence to import is not a standing permission to buy as much as the market wants. Each consignment needs an import authorisation from Kenya, which the exporting country’s authority must see before it issues its own export authorisation.
- Volumes must match medical need. Quantities are tied to Kenya’s estimates. An importer that cannot show where the product will go, and that the demand is genuine medical demand from hospitals, hospices and pharmacies, should expect scrutiny or refusal.
The European exporter faces the mirror-image controls in its own country, so a legitimate supply chain will involve licensed parties and paperwork at both ends.
The Other Two Layers
The business licence. Distributing medicines at wholesale requires a wholesale dealer’s licence under section 27 of the Pharmacy and Poisons Act (Cap. 244), issued per premises and renewed every year, with a resident registered pharmacist in control of distribution. Our guide on obtaining a pharmaceutical wholesale licence in Kenya explains this licence. It does not, by itself, authorise any dealing in controlled substances.
Product registration. Rule 3 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 prohibits importing or selling any health product in Kenya unless it is registered. Each controlled medicine, in each strength and dosage form, must be registered before it can lawfully be imported.
Record-Keeping, Security and Diversion Risk
The section 16 Board can prescribe the records to be kept by anyone who imports, receives, sells or distributes controlled substances, and section 18 of Cap. 245 makes it an offence to fail to furnish information or produce records when lawfully required. Controlled stock must be stored securely, reconciled frequently and supplied only to persons authorised to receive it.
Regulators and banks look closely at controlled-substance businesses because of the risk that legitimate supply chains are used to divert opioids into illicit markets. A credible applicant can show a clear ownership structure, licensed counterparties, realistic volumes and named institutional customers. An enquiry that leads with a specific opioid, offers no customer base and seeks to acquire an existing licence quickly has the opposite profile.
How We Can Help
Clay & Associates Advocates advises pharmaceutical companies, hospitals and distributors on controlled-medicine licensing, product registration and compliance frameworks, after full client due diligence. Our guide for foreign pharmaceutical companies entering Kenya covers the wider regulatory map. Contact our Life Sciences and Healthcare team or our Regulatory and Compliance practice to discuss a compliant structure.
Sources: Narcotic Drugs and Psychotropic Substances (Control) Act (Cap. 245), sections 2, 4, 16 and 18; Pharmacy and Poisons Act (Cap. 244), section 27; Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, rule 3; International Narcotics Control Board, estimated world requirements for narcotic drugs.
Frequently asked questions
Is a PPB wholesale licence enough to import morphine or oxycodone?
No. A wholesale licence covers the business of dealing in medicines. Controlled medicines also need a licence under Cap. 245, an import authorisation for each consignment, and registration of each product.
Can we import as much as our customers order?
Not necessarily. Imports of narcotic drugs are capped by Kenya’s estimates confirmed by the INCB, and each consignment is authorised separately.
What happens if a consignment arrives without the right authorisation?
Unlicensed importation falls within the statutory definition of trafficking, which carries heavy fines, long prison terms and forfeiture of the goods.
Can we buy a company that already holds these licences?
Licences and premises registrations are tied to the holder and its circumstances, and a change in ownership triggers regulatory consequences. Any acquisition needs regulator engagement before completion, not after.
Need advice on your own matter?
Tell us what you are dealing with. You will know what it involves and what it costs before you commit.
This article is general information on Kenyan law as at its publication date, not legal advice. Reading it does not create an advocate and client relationship.
