Kenya Regulatory Cost Guide
PPB Fees in Kenya: The Complete Regulatory Cost Guide
Every official Pharmacy and Poisons Board (PPB) fee in one place: product and medical device registration, premises and professional licensing, import permits, and GMP audits. These are the statutory government charges, separate from any consultant or agent fee.
What these fees are
Two schedules set what the PPB charges. Product and medical device registration fees are billed in US Dollars under the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, Second Schedule. Premises, professional, import and GMP fees are billed in Kenya Shillings under the fee notice made under the Pharmacy and Poisons Act.
Some are one-off (registering a product, registering premises). Others recur every year (a wholesale dealer's licence, a device renewal, personnel retention). When we act for a client, these government charges are passed through to you at cost; our professional fee is quoted separately.
Figures below are the gazetted amounts. Schedules are revised from time to time, so confirm the current amount on your PPB PRIMS invoice before you pay.
Product and medical device registration fees (USD)
Per product. Registration and renewal are charged separately.
| Activity | Not made in Kenya | Made in Kenya |
|---|---|---|
| Registration of a health product | USD 1,000 | USD 500 |
| Renewal of registration | USD 1,000 | USD 500 |
| Fast-tracked evaluation | USD 2,000 | n/a |
| Donated health products | No fee | No fee |
Registration and annual renewal are the same amount per class.
| Device class | Registration | Renewal |
|---|---|---|
| Class A (lowest risk) | USD 100 | USD 100 |
| Class B | USD 200 | USD 200 |
| Class C | USD 1,000 | USD 1,000 |
| Class D (highest risk) | USD 1,000 | USD 1,000 |
| Emergency Use Authorization (device or IVD) | USD 2,500 | n/a |
| Activity | Foreign (imported) | Made in Kenya |
|---|---|---|
| Registration | USD 500 | USD 100 |
| Renewal of registration | USD 500 | USD 100 |
| Activity | Fee |
|---|---|
| Registration | USD 50 |
| Renewal or listing | USD 20 |
Licensing, premises and professional fees (KSh)
Charged under the Pharmacy and Poisons Act. Licences marked per year recur annually.
| Item | Fee (KSh) |
|---|---|
| Registration as a pharmacist or pharmaceutical technologist | 5,000 |
| Restoration of a name to the register | 5,000 |
| Professional practice | 5,000 |
| Registration of premises | 10,000 |
| Wholesale dealer's licence (per year) | 30,000 |
| Licence to deal in mining, agricultural and horticultural poisons (per year) | 5,000 |
| Licence to sell Part II poisons (per year) | 5,000 |
| Licence to manufacture drugs (per product) | 5,000 |
| Advertisement (per product) | 5,000 |
| Pharmaceutical representative permit | 5,000 |
Import permit and GMP audit fees
The charges that apply when you import, or when a manufacturing site is inspected.
| Item | Fee |
|---|---|
| Import permit approval | 2% of the FOB (Freight on Board) value |
| GMP audit per site, foreign manufacturing site | USD 4,000 |
| GMP audit per site, local manufacturing site | USD 1,000 |
The import permit fee scales with the shipment value, so a larger or higher-value consignment costs more to clear. GMP audit fees apply where the PPB inspects the manufacturing site as part of registration.
Training, assessment and education fees (KSh)
Show training and institution fees+
Training and assessment for pharmacists and pharmaceutical technologists
| Stage | Kenyan citizen | Foreigner |
|---|---|---|
| Stage / Level I | 9,500 | 22,000 |
| Stage / Level II | 7,000 | 20,000 |
Pharmacy training institutions (course approval)
| Programme | New application | Annual renewal | Student indexing |
|---|---|---|---|
| Degree programme | 400,000 | 60,000 | 1,000 |
| Diploma programme | 210,000 | 30,000 | 1,000 |
Want your own annual premises figure?
This page lists every official PPB fee. If you only need to budget your recurring location cost, the premises and personnel retention for a pharmacy, wholesaler or distributor, use the calculator.
Open the premises and personnel calculatorHow we handle these fees for clients
The figures above are government charges. When Pharma Partner manages a registration or licensing engagement, we pass these through to you at cost and show them as a separate line, so you always see what goes to the PPB and what is our professional fee.
We handle product and device registration through PRIMS, premises and wholesale licensing, import permits, and act as Local Technical Representative for manufacturers based outside Kenya.
Frequently Asked Questions
About PPB registration and licensing costs in Kenya