How to Submit Changes to Registered Medicines in Kenya

When you hold marketing authorisation for a medicine in Kenya, it is vital to keep it updated. Regulatory authorities expect any change—minor or major—to be reported promptly. In Kenya the Pharmacy and Poisons Act (Cap 244) and the associated rules govern such changes.

This article guides you through what you must know, how you should act, and how your business can remain fully compliant.

Understanding What “Changes to Registered Medicines” Means

A “change” or “variation” refers to any alteration in a registered medicine’s details after its approval. Examples include:

• A new manufacturing site,

• Changes in formulation or strength,

• Label or packaging changes,

• Change in distribution channel or licence holder,

• New indication or withdrawal of an indication.

Under the Rules, the Pharmacy and Poisons Board (PPB) must be notified of any alteration that could affect safety, efficacy or quality.

Staying proactive helps avoid enforcement action, delays in marketing or supply disruptions.

When Should You Submit a Change?

You should submit a variation:

• Before implementing the change, if it is major (e.g., manufacturing site, formulation).

• Within a defined timeframe after implementing smaller changes (e.g., labelling wording).

• Immediately when there is a safety-related change (e.g., adverse event, defect).

Failing to notify the regulator may lead to revocation of your registration certificate.

Key Requirements for Submitting a Variation

Here are the main compliance elements when preparing your submission:

Document the Change Clearly

You must describe the change, rationale, supporting data and impact on product quality, safety or efficacy.
The PPB’s guideline emphasises structured dossiers for variations.

Refer to the Legal Framework

Ensure your submission aligns with the Pharmacy & Poisons Act (Cap 244) and Regulations.

Use the Online Portal

The PPB requires submissions through its portal (for instance for registration and renewals).

Pay Applicable Fees

Variations may carry fees or retention requirements depending on the type of change and timeframe. Consult the current fee schedule.

Keep Records and Track Changes

Document the change, internal approvals, and retain submission proof. That helps during inspections or audits.

Step-by-Step Process to Submit a Change

Here’s a practical sequence you can follow:

1. Assess the Nature of the Change
   Determine whether the change is minor, major or safety-related.
   Minor: packaging, non-critical labelling text.
   Major: formulation, manufacturing site, indication.
   Safety-related: adverse reaction, defect.

2. Prepare Supporting Data
   For major changes, include technical documents: justification, validation, stability, risk assessment.
   The PPB guideline highlights the need for detailed information especially for APIs and finished products.

3. Complete Variation Application Form
   Log into the PPB submission portal → fill the variation request form → attach required documents.

4. Submit Payment and Application
   Ensure fees are paid. Submit the form with supporting documents via the portal or according to PPB instructions.

5. Await Acknowledgement and Reference Number
   The PPB assigns a submission number. Use it for tracking and communication.

6. Implement the Change (if allowed) or Wait for Approval
   Some major changes require PPB approval before implementation. For minor ones, you may implement while awaiting formal acknowledgement (depending on PPB policy).

7. Monitor the Review Process
   Respond to queries from PPB promptly. Delay may result in rejection or request for more data.

8. Receive Variation Approval
   Upon approval, update your marketing documents, labels, packaging and supply chain accordingly.

9. Update Internal Systems and Records
   Inform relevant stakeholders, update SOPs, quality systems, staff training.

 

Best Practices to Improve Your Submission Success

• Use clear, active-voice language in your submission.

• Label documents with version numbers and dates.

• Keep paragraphs short and headings distinct for readability.

• Provide a cover letter summarising the change.

• Use transition words like “furthermore”, “consequently”, “therefore” to ensure flow.

• Link to authoritative external sources to support your rationale.

• Maintain high-quality formatting, naming conventions and consistent references.

 

How Clarity Pharma Consultancy Can Assist You 

If you need expert support navigating variation submissions to the PPB, we can help. At Clarity Pharma Consultancy, our team guides you through regulatory classification of change, dossier preparation, submission tracking and compliance assurance. We ensure your product stays compliant and supply continuity remains intact.

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