Pharmaceutical Manufacturing Licence Kenya 2026: PPB Fees and GMP

Updated 1 November 2026

A pharmaceutical manufacturing licence Kenya factories need is issued by the Pharmacy and Poisons Board (PPB) and only after the site shows acceptable Good Manufacturing Practice (GMP) compliance. PPB’s October 2025 premises guidelines list four charges for manufacturing premises: KSh 50,000 for the manufacturing licence, KSh 30,000 for a wholesale dealer’s licence, KSh 10,000 for premises registration and KSh 5,000 for the annual practice licence, so KSh 95,000 in year one. The licence covers specific dosage forms, products and operations, and expires every 31 December.

Updated 1 November 2026 from the PPB Guidelines for Registration and Licensing of Premises (October 2025), sections 2.20, 4.3 and 5.0.

Pharmaceutical manufacturing licence Kenya fees

Source: PPB Guidelines for Registration and Licensing of Premises, section 5.0. Facilities in Special Economic Zones and EPZs may be exempt from the premises, wholesale and manufacturing licence fees, though staff must still hold paid-up practice licences. Product registration fees are separate and billed in US dollars under the 2022 registration rules.

What PPB requires before licensing a factory

• GMP first. A manufacturing licence cannot be issued, varied or reinstated on paperwork alone; PPB must confirm acceptable GMP status in every case, reflected in a PPB GMP certificate on the PRIMS portal.
• Facility standards follow the Guidance Notes for Establishing Medical Products and Health Technologies Manufacturing Facilities (HPT/ISE/GMP/MAN/006).
• Key personnel must meet document HPT/ISE/GMP/MAN/009 on qualifications, experience and responsibilities.
• Product list: submit the approved products to be made at the site.
• Two-level review of every new licence and every variation, suspension or reinstatement, with specific reasons if declined.

Documents for the application

1. Certificate of incorporation
2. Signed memorandum and articles, or a current CR12
3. Company KRA PIN certificate (company KRA PIN guide)
4. Affidavit and/or appointment letter of the superintendent pharmacist
5. List and CVs of key technical personnel
6. Any other documents PPB specifies for your scope

Declaring your manufacturing scope

You must declare, and PPB must approve, the scope of the licence:

• Dosage forms (for example oral solids, oral liquids)
• Broad categories (sterile, non-sterile, biological)
• Specific categories (general products, cephalosporins, penicillins and other beta-lactams)
• Product types (for example hard gelatin capsules, dry syrups in glass bottles, oral powders)
• Each product made or proposed
• Site activities: manufacturing, processing, batch certification, primary and secondary packaging, testing, storage

No activity or product outside the approved scope is allowed without prior PPB approval. You can apply for a variation during the licence year.

How the licence is issued

1. The company pharmacist applies on the PPB online licensing portal, attaching GMP evidence.
2. Export-only products (not registered in Kenya) are declared on the GMP portal and verified by PPB’s GMP division.
3. After final approval you download the licence with an annex listing export-only products.
4. You then declare products with Kenyan marketing authorisation; after verification, PPB lets you re-download the licence with a second annex listing them.

Temporary manufacturing licence

Where some GMP requirements can only be proven by actually manufacturing (process validation, equipment qualification, cleaning validation, media fills, validation batches), PPB may issue a temporary licence with a set scope, conditions, duration and exit criteria, but only once all critical quality, safety, personnel and facility requirements are met.

Renewal

All PPB licences expire on 31 December. Apply through the portal’s Renewal tab at least 30 days before expiry, attaching a valid PPB GMP certificate. Late applications attract penalties.

Other approvals for a pharma plant

Expect a NEMA EIA licence (see our NEMA EIA licence guide), county permits and building approvals. For distribution, see the list of pharmaceutical importers and distributors in Kenya and how to register a pharmacy.

Pharmaceutical manufacturing licence Kenya: planning timeline

Because GMP evidence is required before PPB issues the licence, plan the project in stages: design the facility to the PPB guidance notes, build and qualify equipment, hire qualified key personnel, prepare documentation (SOPs, batch records, validation protocols), then request the GMP inspection. Where validation batches are needed, the temporary licence route allows controlled production. Engaging PPB early on facility drawings avoids costly rebuilding later.

Budget for more than the KSh 95,000 in PPB licence fees. Product registration is charged per product in US dollars, and each new dosage form or product category needs PPB approval of scope. Annual costs include the manufacturing and wholesale licences, practice licences for each pharmacist, GMP re-inspections and quality control testing. Keeping the pharmaceutical manufacturing licence Kenya regulators grant depends on staying inside the approved scope and passing those inspections.

Frequently asked questions

How much is a pharmaceutical manufacturing licence in Kenya?

The manufacturing licence is KSh 50,000. With the wholesale licence, premises registration and practice licence, year one totals KSh 95,000 in PPB fees.

Do I need GMP certification to get a manufacturing licence?

Yes. PPB requires confirmation of acceptable GMP compliance in every case.

Can PPB issue a temporary licence?

Yes, for limited, controlled manufacturing needed to complete GMP validation, once critical requirements are already met.

When does the licence expire?

On 31 December each year.