How to Stay Compliant: Pharmacy Premises Licensing in Kenya

Opening and running a pharmacy in Kenya demands more than a business idea—it requires strict compliance with regulatory standards. The Pharmacy and Poisons Board (PPB) sets clear rules for licensing pharmacy premises.

In this article, you will discover the steps, requirements, and best practices to stay on the right side of the law.

Understanding Pharmacy Premises Licensing in Kenya

Licensing a pharmacy premises means registering the physical facility where pharmaceutical business occurs.

The PPB mandates that any business dispensing medicines must operate from a licensed, inspected, and compliant premise under the law.By obtaining the correct licence, you safeguard public health and protect your business from penalties.

Why Compliance Matters in the Pharmaceutical Sector

Operating without the correct licence or in non-compliant premises can lead to fines, closure or prosecution. The law protects consumers by requiring safe premises, qualified staff, and proper processes.

Also, compliance builds trust with customers, regulators and partners—helping your pharmacy establish a strong reputation.

Key Requirements for Licensing a Pharmacy Premises in Kenya

Here are the major areas you must meet:

1. Premises Suitability

Your building must meet hygiene, ventilation, storage, and layout standards. For example: floors and walls need to be wash-able, the premises must protect medicines from heat and pests.

The space should be dedicated solely for the pharmacy business and not a mixture with non-related trade.

2. Superintendent Pharmacist Responsibility

A licensed pharmacist must supervise the operations. The PPB requires that the superintendent holds a valid practice licence.

Without a qualified professional, the application will likely be rejected.

3. Documentation and Application Process

You must submit forms, floor plans, business registration, the pharmacist’s credentials, and payment as prescribed in the guidelines.

Clear and complete documentation increases your chances of approval.

Step-by-Step Licensing Process in Kenya

Follow these steps to secure your licence:

Step 1: Business Registration

Register your business entity with the relevant registry (for example BRS Kenya). This gives your pharmacy a legal structure before applying to PPB.

Step 2: Appoint and Register the Superintendent Pharmacist

Ensure the pharmacist is registered and holds the required practice licence. The pharmacist must be named and approved by PPB.

Step 3: Apply for Premises Registration

Submit the “Application for Registration of Premises” (Form 4), plus required annexes and documentation.
Pay attention to the portal or manual process as specified by PPB.

Step 4: Inspection by PPB

After submission, the PPB will inspect the premises to verify compliance with standards. Inspection covers premises layout, storage conditions, and pharmacist presence.

Step 5: Licence Issuance

If your premises pass inspection, PPB issues the licence. Note: some licences expire 31st December of each year and require renewal.

PPB Inspection Checklist: What Inspectors Look For

During the inspection, expect the following focus areas:

• Proper storage of pharmacy-only and over-the-counter drugs.

• Security for controlled substances and poisons.

• Licensed pharmacist on-site or evidence of supervision.

• Floor, wall and ceiling surfaces that are easy to clean.

• Documentation displayed: licence certificate, pharmacist’s credentials.

• Good dispensing area layout with no crowding and clear workflow.

 

Common Mistakes That Lead to Non-Compliance

Avoid these pitfalls:

• Operating without a licensed superintendent pharmacist.

• Using premises that don’t meet structural or hygiene standards.

• Failing to submit correct or complete documentation.

• Mixing retail and wholesale activities in one premise without separate licences.

• Late renewal of license or expiry of registration.

 

Penalties for Non-Compliance in Kenya

The law sets harsh consequences for unlicensed or non-compliant premises. Under the Pharmacy and Poisons Act Cap 244, offences can attract fines, imprisonment, or both.

Because of this, maintaining compliance is not optional—it is essential for sustainable business.

Renewal of Premises Licence

Most licences issued by PPB expire at the end of the calendar year (31 December). Applicants must apply each year to renew. Early renewal avoids late fees or business interruption.

Best Practices for Maintaining Compliance All Year Round

Here are practical steps you can implement:

• Perform monthly internal audits of your operations and premises.

• Keep the pharmacist’s credentials and licence displayed and up-to-date.

• Maintain records of inspections, temperature logs, expiry checks.

• Train staff on Good Pharmacy Practice and compliance culture.

• Engage with a professional consultancy for regular compliance reviews.

If you need expert support, Clarity Pharma Consultancy offers tailored advisory services on licensing, inspections, regulatory updates and compliance strategy for Kenyan pharmacies.

Licensing your pharmacy premises in Kenya is a rigorous process—but with the right preparation, you can succeed and build a reputable, compliant business.

Adhering to PPB’s standards, maintaining a qualified superintendent pharmacist, meeting the premises requirements, and staying compliant year-on-year will set you up for success.

Start today, stay ahead of regulatory changes, and safeguard both your business and your community.

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