Registering Medicines with the Pharmacy & Poisons Board in Kenya

Navigating medicine registration in Kenya can be complex. The Pharmacy & Poisons Board (PPB) regulates all medicinal substances under the Pharmacy and Poisons Act, Cap 244. This process ensures that only safe, effective, and quality medicines enter and remain in the Kenyan market.

In this guide, we walk you through each step — from application to approval — so you stay compliant, protect public health, and succeed with your pharmaceutical product.

Why Register Medicines with the PPB?

Before diving into the process, it’s worth understanding why registration matters:

1. Legal Obligation: Under the Pharmacy and Poisons (Registration of Drugs) Rules, no one can import, manufacture, or sell a drug in Kenya unless it is registered.

2. Public Safety: Registration ensures that medicines meet standards of safety, quality, and efficacy.

3. Market Authorization: The PPB issues a marketing authorization, which gives legal status to the product in Kenya.

 

Step 1: Prepare Your Dossier (Application Package)

First, compile a complete dossier in the required format. According to PPB guidelines, you should prepare:

- CTD (Common Technical Document) modules for quality, safety, and efficacy.
- A stability report for both active pharmaceutical ingredients (APIs) and finished products.
- A Summary of Product Characteristics (SmPC) detailing dose, side effects, contraindications, and more.
- Certificates, such as the Certificate of Pharmaceutical Product (CPP) from the country of origin if imported.

Make sure your documents are in English. If some are in another language, provide a certified translation.

Step 2: Appoint a Local Agent (If Applicable)

If your product is manufactured outside Kenya, PPB requires you to have a local agent or representative in Kenya:

• The local agent usually holds power of attorney.

• This agent must be a registered drug wholesaler with the PPB.

 

Step 3: Submit Your Application to PPB

Once your dossier is ready:

1. Fill out Form 1 (for new drug registration) or Form 1A (for renewal) as prescribed in the PPB rules.

2. Submit one hard copy and one electronic copy (PDF), along with a Word version for Modules 1 and 2.

3. Send three samples of the smallest commercial pack from one batch, along with certificates of analysis.

4. Include your non-refundable application fee. According to the rules, the fee is KES 5,000 for imported drugs, and KES 1,000 for locally manufactured ones.

 

Step 4: Pay Registration and Inspection Fees

After submitting your application, you must pay:

• The registration application fee (see step 3).

• If your manufacturing site hasn’t been inspected by PPB before, you may need to pay for a Good Manufacturing Practice (GMP) inspection.

PPB may inspect your plant to ensure compliance with GMP.

Step 5: PPB Evaluation Process

After you submit:

1. PPB reviews your dossier for completeness and scientific merit.

2. A Committee on Drug Registration evaluates the application.

3. PPB may request additional data or clarifications. You must respond within six months or risk withdrawal.

4. Once satisfied, PPB issues your Certificate of Registration (Form 2).

If they reject the application, they must provide written reasons. You can appeal or reapply.

Step 6: Post‑Approval: Retention, Variation, and Renewal

Retention

Registered medicines must be “retained” annually by submitting certain documentation.

Variations

If you change any part of your product (formulation, pack size, manufacturing site), apply for a variation through PPB.

Renewal

Drug registration is valid for five years, after which you must renew to continue marketing.

Step 7: Compliance & Market Surveillance

After registration, stay compliant by:

• Keeping accurate batch records

• Performing quality control tests on manufactured or imported batches

• Observing labeling requirements and package inserts

• Responding to PPB’s market surveillance checks

PPB has issued warnings against unregistered products. In 2025, they cautioned pharmacies and importers against selling drugs that reference the Indian Pharmacopoeia (IP), as they do not meet Kenya’s regulatory standards.

Common Challenges & How to Overcome Them

• Incomplete Dossier: Double-check every module before submission.

• Delayed Responses: Assign a responsible officer to handle PPB queries and follow up.

• Inspection Failures: Prepare thoroughly for GMP inspection; ensure your facility meets standards.

• Misunderstanding Fees: Know whether your product is imported or locally made — fees differ.

• Non‑compliance Post‑Registration: Set up internal quality systems to stay audit-ready.

 

How Clarity Pharma Consultancy Can Help

Navigating the PPB drug registration process can be daunting, especially for first-time applicants. Clarity Pharma Consultancy offers expert guidance on every step — from compiling your dossier to preparing for GMP inspections and maintaining compliance after registration.

If you want to fast‑track your application, avoid common pitfalls, and comply with all PPB requirements, reach out to Clarity Pharma Consultancy today for a tailored consultation.

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