Kenya Pharmaceutical Licensing

The PPB regulates premises licensing, professional practice, product registration, imports and exports, and safety reporting as separate areas. Company incorporation or a business name search does not replace PPB premises licensing; nor does a premises licence automatically confer authority for products, trading or individual practice. The PPB is the national competent authority, and regional offices participate in inspections; the materials reviewed do not establish a list of additional trading, planning or health permits applicable across all counties. Pharmacy businesses are also subject to the PPB’s wording concerning the professional status of holders of financial interests; this must not be presented directly as a general conclusion about company form or foreign investment.

— Retail: premises, person-in-charge practice licence and GDP.

— Wholesale: premises/wholesale licence and GDP.

— Manufacturing: premises/GMP; products and trading require separate authorisations.

The PPB regulates the pharmacy profession and the manufacture and trade of medicines and poisons under Cap. 244. Its functions include premises/practice licensing, GMP for manufacturers, GDP for distributors, product market access, import/export controls and post-market surveillance. Kenya Law publishes the principal legislation and subsidiary rules; its 1957 rules page lists fees and import/export/manufacturing items, but the page itself marks the legal notice as “Uncommenced.” Therefore, where procedures and fees do not align with the current PPB portal, they should be verified with the PPB.

— PPB: licensing, inspections, and product and trade regulation.

— Regional PPB offices: contact for premises inspections.

— Kenya Law: publishes legal sources; does not receive applications.

For a new premises, a qualified professional should log in to the Practice Portal, select New Facility, enter the premises details and attach an E-citizen business name search. After the initial review, complete the requirements for the premises type and make payment; the regional office will contact the applicant to arrange an inspection, followed by a final review. Once approved, the licence holder can download and print the licence and display it at the premises. Retail pharmacies are subject to GDP inspections; online pharmacies and hospital pharmacies have separate additional requirements that are not automatically covered by a general retail licence.

— Apply for new premises through the PPB portal.

— Begin operations only after inspection and final review are complete.

— Display a valid licence and maintain the person-in-charge’s practice authorisation.

The PPB treats wholesale and retail as part of the therapeutic products supply chain and requires wholesalers to handle, store and distribute products safely. The GDP Division inspects wholesalers, retailers, hospital pharmacies and ports of entry, and applies risk-based supervision and compliance certification. Wholesalers should operate a quality system subject to inspection to manage receipt, storage, dispatch, transport, quarantine, returns and traceability; general official webpages do not specify a fixed warehouse area, temperature or humidity values, or staffing complement applicable in all cases.

— Apply for and undergo inspection for the actual wholesale premises.

— Maintain documented GDP controls and traceable records.

— Submit details of the person in charge and directors for renewal as required by the portal.

The PPB GMP Division inspects local and international manufacturing facilities to confirm that personnel, premises and practices comply with requirements; the PPB states that manufacturing licence holders must comply with GMP and that GMP compliance at the manufacturing site is also confirmed for market access. The manufacturing facility establishment guidelines apply to new construction, upgrades and maintenance/auditing of operating facilities, and cover layout, environmental controls, air/water, waste, cleanrooms, equipment validation and maintenance, and quality control. For renewal of a manufacturing premises licence, the current PPB GMP certificate must be uploaded.

— Design the facility in accordance with the processes, equipment and quality controls.

— Cooperate with GMP inspections and remedy deficiencies.

— Maintain the applicable PPB GMP certificate before renewal.

Individual authorisation and premises authorisation are separate. The PPB requires registered pharmacists and enrolled pharmaceutical technologists to obtain a practice licence; manufacturing, dispensing, compounding, prescription preparation and pharmaceutical services all constitute the practice of pharmacy. The person in charge of premises must be a registered/enrolled professional, have at least three years’ experience after enrolment, and be responsible for only one premises. Annual practice licences are subject to CPD requirements; the PPB FAQ specifies at least 20 CPD points.

— Individual: PPB registration/enrolment and a valid practice licence.

— Person in charge: meet the experience requirement, with one person per premises.

— Renewal: maintain CPD; the person in charge must apply first.

Pharmaceutical premises must correspond to the licence and the actual business activity. New applications are based on the actual address and an inspection; the licence may be downloaded and displayed only after approval. Distribution should be managed under GDP, covering personnel, premises and actual practices; manufacturing should be managed under GMP, covering structure/layout, environmental controls, equipment and quality control. Hospital renewals require the medical council licence for that year, while manufacturing renewals require a current PPB GMP certificate, showing that requirements for different premises types are not interchangeable.

— Retail/wholesale: prepare for an on-site GDP inspection.

— Manufacturing: premises and equipment must support a GMP quality system.

— Obtain approval for a change before relocating or making a significant change to premises details.

For new premises, the person in charge logs in to the portal using their PPB registration/enrolment number and submits premises details, a business name search and applicable attachments, then provides any additional documents, makes payment and undergoes an inspection as instructed. The PPB FAQ gives examples: sole proprietorships, partnerships and Kenyan private limited companies should provide documents such as BN3, a partnership deed, a certificate of incorporation and CR12, respectively. The business name, ownership selection and attachments must be consistent. Manufacturing applications should also prepare GMP/facility documentation, while product applications are submitted separately with documents such as a CTD dossier.

— First confirm the premises type, person in charge, business and actual address.

— Submit through the portal and cooperate with requests for further information, payment and inspection.

— Prepare GMP and market access documentation in parallel for manufacturing and product applications.

The PPB FAQ states that fees are prescribed by law, listing KSh 5,000 for an annual individual practice licence, KSh 10,000 for premises registration, KSh 30,000 for an annual wholesaler licence, and KSh 50,000 for a manufacturing licence. The Kenya Law rules page also lists some amounts, but states “KSh 5,000 per product” for manufacturing, and indicates that the legal notice has not entered into force. Manufacturing applicants should first obtain PPB confirmation for their actual project. PPB has not published a guaranteed processing period in working days or an expedited route on the process pages reviewed; all PPB licences currently expire on 31/12 of the licensing year.

— Confirm fees against the current PPB portal, licence category and scope of business.

— Payment does not guarantee a timeframe or outcome.

— Renew individual, premises and applicable GMP status before expiry.

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The PPB requires those licensed to distribute and sell to comply with GDP and conducts risk-based inspections of retail, wholesale and hospital pharmacies; manufacturers must maintain GMP, accurate and up-to-date manufacturing/quality documentation, and site compliance. For renewals by the person in charge, retailers or wholesalers submit director details, hospitals upload the annual medical council licence, and manufacturers upload the current PPB GMP certificate. The PPB also conducts post-market surveillance, including sampling, testing, alerts, market withdrawals and recalls.

— Renew premises and individual licences on time and maintain CPD.

— Maintain GDP for distribution; maintain GMP and certification for manufacturing.

— Establish responses to quality incidents, complaints, returns and recalls.

The PPB defines a variation as a post-licensing change made before the licence expires and states that the law requires the PPB to be notified and approval obtained. The portal requires the applicant to select a variation category, state the reason, upload evidence and pay where necessary. Evidence may include a resignation letter, appointment letter, formal employment contract and company documents; ownership, director/shareholder and beneficial owner details should be supported by documents such as CR12, BN3 or a partnership deed. The PPB does not describe an equity transaction as automatically transferring a licence.

— First distinguish changes to individual practice from changes to premises/business licences.

— Submit the correct category and matching evidence through the portal.

— Verify financial interests, the person in charge and beneficial ownership details before a transaction.

Product market access is separate from premises licensing. The PPB states that all human medicines must obtain market access before sale or distribution; applications generally include a CTD dossier, samples, labelling, CPP and other documents. Market access is valid for five years and should be renewed three months before expiry; product changes such as formulation, manufacturing site or labelling must be submitted and approved in advance. Import/export permits are handled online by the PPB Trade Affairs Unit; at the port of entry, documents are verified, pre-clearance inspections are conducted, and release or refusal is decided.

Narcotic drugs, psychotropic substances and precursor chemicals are additionally governed by PPB controlled substances guidelines. Authorised importers/exporters, manufacturers and wholesalers must also comply with DDA licensing, secure storage, controlled stock, recordkeeping for at least five years, and quarterly/annual reporting requirements; a general business licence cannot substitute for this authorisation.

— Check market access, authorisation holder and manufacturing site for each SKU.

— Prepare each cross-border shipment in accordance with PPB permits and port requirements.

— Obtain separate DDA permits, and maintain records and submit reports for controlled substances.