How to Obtain a Pharmaceutical Wholesale Licence in Kenya

Any business that wants to import, store and distribute medicines to pharmacies, hospitals and clinics in Kenya needs a pharmaceutical wholesale licence before it sells a single unit. The legal basis is section 27 of the Pharmacy and Poisons Act (Cap. 244), which requires a licence from the Pharmacy and Poisons Board (PPB) to deal as a wholesale dealer in poisons. Because medicines included in the Poisons List made under section 25 are treated as poisons for the purposes of the Act, this licence is the gateway to the pharmaceutical distribution trade. This guide explains what the law requires, where foreign investors usually go wrong, and how the licence fits with product registration and premises approval.

What Section 27 Actually Requires

Section 27 gives the PPB a discretion, not a duty. The Board may issue or renew a wholesale dealer’s licence if it is satisfied that doing so is in the public interest, on a written application in the prescribed form and payment of the prescribed fee. Four features of the section shape every application:

• One licence per premises. Section 27(3) requires a separate licence for each set of premises where the business is carried on. A company with a Nairobi warehouse and a Mombasa depot needs two licences.
• A resident pharmacist in control. Under section 27(4), no licence may be issued or renewed unless the applicant is, or has, a registered pharmacist in control of the distribution of the poisons, and that pharmacist is resident in Kenya.
• Annual expiry. Every licence expires on 31 December of the year of issue (section 27(5)), so renewal is a yearly compliance event, not a one-off.
• Criminal liability. Dealing as a wholesale dealer without a licence is an offence under section 27(7).

The Board may also refuse, decline to renew or revoke a licence for any good and sufficient reason relating to the applicant or the premises. The appeal lies to the Cabinet Secretary responsible for health, whose decision the section describes as final, although judicial review remains available where the decision is unlawful, unreasonable or procedurally unfair.

Company Structure and the Superintendent Pharmacist

Most wholesalers operate through a limited company. Section 21 of the Act allows a body corporate to carry on the business of a pharmacist without itself being registered, provided its business is managed by a superintendent who is a registered pharmacist and a member of the company’s board of directors, and who is not acting as superintendent for any other company. A copy of the certificate of incorporation must be lodged with the Board.

For a foreign investor this means the Kenyan subsidiary must have a registered pharmacist on its board from the outset. The role carries real legal responsibility, and the person must actually exercise control. We cover the role in detail in our guide to the superintendent pharmacist in a Kenyan pharmaceutical company.

Premises Registration and Inspection

Section 23 makes it unlawful to carry on the business of a pharmacist except in premises registered with the Board. In practice, the PPB inspects the proposed warehouse before licensing, and expects storage conditions that meet its good distribution practice standards: temperature and humidity control, pest control, security, segregation of quarantined, rejected and returned stock, and documented stock management.

One provision catches many buyers out. Under section 23(3), the registration of premises becomes void thirty days after any change in the ownership of the business carried on there. An investor who buys a licensed business therefore cannot assume the existing approvals will simply continue; the change must be planned with the Board in advance.

The Licence Does Not Cover the Products

A wholesale licence authorises the business, not the medicines it handles. Rule 3 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 prohibits any person from importing, manufacturing or selling a health product in Kenya unless that product has been registered under the Rules. Every product a wholesaler intends to import must already be registered, usually by its manufacturer.

Where the applicant for product registration is not a Kenyan citizen or is a company incorporated outside Kenya, rule 4(2)(b) requires it to appoint a local representative who is a Kenyan citizen, a permanent resident or a Kenyan-incorporated company. A Kenyan wholesaler often takes on this role for its foreign principals, which creates contractual and regulatory obligations worth documenting carefully. Our guide on pharmaceutical product registration in Kenya covers that process.

Controlled Medicines Need a Separate Regime

A wholesale dealer’s licence does not authorise dealing in narcotic drugs or psychotropic substances. Those are governed by the Narcotic Drugs and Psychotropic Substances (Control) Act (Cap. 245), which requires a separate licence and, in practice, an authorisation for each import or export consignment. Importing a controlled medicine without the correct authority falls within that Act’s definition of trafficking. We explain the regime in our guide to importing narcotic and psychotropic medicines into Kenya.

Common Mistakes by New Entrants

• Treating the pharmacist as a formality. Name-lending, where a pharmacist’s registration is used without real involvement, exposes the company, its directors and the pharmacist. Section 49 of the Act makes every director, secretary and manager liable for an offence committed by the company unless they prove it happened without their consent and that they exercised due diligence.
• Signing a lease before the premises are approved. Negotiate a lease that is conditional on PPB approval, or at least gives an exit if the warehouse fails inspection.
• Ignoring pending reform. Parliament has been considering legislation to replace the PPB with a new regulator. Our note on the Health Products and Technologies Regulatory Authority Bill explains what may change.

Frequently asked questions

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.