Misunderstanding these requirements is not limited to Marketing Authorization Holders; importers, distributors, and LTRs also struggle with clarity. This article explains the difference and consequences of each, based on PPB’s official guidelines.
Annual retention
Definition: Retention is the yearly requirement to keep a registered product active in the PPB database.
Process: The MAH or Local Technical Representative confirms product details, submits updates if required, and pays the annual retention fee.
Consequence of non-compliance: Failure to retain means the product cannot be imported, distributed, or sold until retention is completed.
Purpose: Ensures PPB maintains an up-to-date record of all products on the Kenyan market.
Key point: Retention is about continuity — keeping the product “live” in the system year by year.
Renewal
Definition: Renewal is the five-year requirement to extend the validity of a Marketing Authorization (MA).
Process: Renewal applications must be submitted at least three months before expiry.
Consequence of non-compliance: Failure to renew leads to deregistration or removal from the PPB register, meaning the product loses its legal authorization and must undergo a fresh registration process.
Purpose: Ensures long-term compliance and that products continue to meet evolving regulatory standards.
Key point: Renewal is about validity — extending the legal authorization beyond its initial five-year term.
Retention vs renewal: at a glance
| Requirement | Frequency | Responsibility | Consequence if missed |
|---|---|---|---|
| Annual retention | Every year | MAH / LTR | Product cannot be imported or sold until retention is completed |
| Renewal | Every 5 years | MAH / LTR | Deregistration or removal from PPB register; product loses authorization |
Practical guidance for MAHs
- Build retention into your regulatory calendar as a yearly compliance anchor.
- Track renewal dates well in advance — start preparation at least 12 months before expiry.
- Use your LTR to manage communication with PPB and ensure submissions are timely.
- Consult PPB’s Service Charter for timelines specific to your product category.
Conclusion
Retention and renewal are complementary obligations: retention keeps your product active year by year, while renewal extends its legal authorization every five years. Missing retention halts importation until resolved, but missing renewal results in deregistration — a far more disruptive outcome. Together, they form the backbone of Kenya’s regulatory lifecycle, and mastering both ensures uninterrupted market access.