Importing medicines into Kenya

The regulator

The Pharmacy and Poisons Board (PPB) is the state corporation under the Ministry of Health that regulates medicines under the Pharmacy and Poisons Act (Cap 244). Its Guideline on Import and Export of Health Products and Technologies (revision 2, February 2026) sets out 14 types of import permit.

Key rules from that guideline:

• Import permits are pre-shipment applications, filed on the Trade Facilitation Platform of the Kenya National Electronic Single Window (KenTrade).
• A permit is used once, cannot be transferred and is valid for one year, with a possible extension of one to three months.
• Goods enter only through gazetted ports of entry, where PPB inspectors check the declared batch numbers before release.
• Import records must be kept for five years.

Legal routes for unregistered medicines

Letter of authorization to import unregistered products

PPB issues this letter to authorize import through the non-routine marketing authorization pathway. The guideline makes it a prerequisite for any import permit covering a product that is not registered.

Compassionate use authorization

PPB's emergency and compassionate use guidelines (2020) cover patients with a chronically or seriously debilitating or life-threatening condition who cannot be treated satisfactorily with a registered product. The marketing authorization holder files a cover letter and dossier. Published review targets are 7 calendar days for abridged or WHO EUL-listed products and 30 calendar days for an initial assessment.

Prescription drug import permit

This permit covers medicines for a specific patient, limited to 3 months of supply in most cases. The patient, guardian, doctor or hospital appoints a pharmaceutical company with a wholesale dealer's licence to apply. It needs a proforma invoice, a prescription, a doctor's letter of duty of care or a compassionate use letter, and the wholesaler's licence. There is no fee.

Donations and other permits

Donated products need a PPB donation authorization certificate and a donation import permit. A separate priority import permit, with no fee, covers registered oncology, antimalarial, antiretroviral and anti-tuberculosis medicines. The parallel import rules of 2019 do not apply to unregistered medicines for named patients and hospitals, orphan medicines or compassionate use.

Documents a buyer usually needs

• PPB import permit approved on KenTrade
• Letter of authorization to import unregistered products, or a compassionate use authorization letter
• Prescription or the doctor's letter of duty of care for the patient
• Wholesale dealer's licence of the Kenyan importer
• Proforma invoice, commercial invoice and packing list
• Certificate of analysis for each batch, and a certificate of pharmaceutical product from the country of origin
• Air waybill, and for donations the donation authorization certificate

Timeline: a worked example

A teaching hospital in Nairobi needs an oncology medicine that is not registered in Kenya for a named patient.

Total: roughly 2 to 7 weeks, depending mainly on whether PPB asks for a separate authorization letter. These are planning estimates, not published service times.

Shipping lanes from India

Kenya Airways and IndiGo both fly nonstop between Mumbai and Nairobi, a flight of about six hours into Jomo Kenyatta International Airport (NBO). Shipments from Delhi, Hyderabad, Bengaluru or Chennai usually connect through Mumbai or a hub such as Dubai, Doha or Addis Ababa. Express courier service is usually 3 to 6 days door to door. Air cargo is usually 4 to 9 days including PPB checks and customs.

CIP, CPT and DAP to Nairobi are common, and FCA suits importers with their own forwarder. The Kenyan importer must add batch or lot numbers on the trade platform before the goods arrive, so share them as soon as the batch is allocated.

Practical tips for buyers

• In January 2025 PPB warned against unregistered products citing the Indian Pharmacopoeia, saying that standard is not within Kenya's registration requirements. Check which pharmacopoeial standard the product's specification cites before quoting.
• Duty on HS 3004 medicines is 0 percent under the East African Community tariff according to World Bank WITS data.
• KRA's July 2026 list shows HS 3004 medicaments as VAT exempt. An import declaration fee of 2.5 percent and a railway development levy of 2 percent are reported, so ask a customs agent whether an exemption applies.
• The commercial medicine permit carries a fee of 0.75 percent of FOB value. Prescription, priority and donation permits carry no fee.