Frequently asked questions
The questions we are asked before every engagement.
Straight answers on representation requirements, dossier delays, quality system alignment, brand protection, and what non-compliance actually costs.
Working with VeroMed
Resolving registration challengesOur product registration in Kenya is facing costly delays. How does VeroMed help resolve this?
We review your dossier for completeness, identify gaps that may be causing PPB queries, and align your submission with assessor expectations. We also provide regulatory intelligence and structured communication support to help you overcome bottlenecks efficiently.
Scientific Office & LTR requirementsWe do not have a physical presence in Kenya. Do we need a local representative to register our products?
Yes. PPB requires foreign companies to operate through a licensed Scientific Office or an authorized Local Technical Representative. VeroMed provides this compliant representation without requiring you to establish a local subsidiary.
The LTR acts as the official point of contact with PPB and is responsible for regulatory submissions, communication, and ensuring compliance obligations are met.
Industry coverageWhich industries does VeroMed support beyond pharmaceuticals?
We work with medical device manufacturers, biotech innovators, distributors, MAHs, and health-system partners seeking compliant market entry into Kenya.
Confidentiality practicesHow does VeroMed protect our confidential regulatory and product information?
We use secure document-handling protocols, controlled access systems, and confidentiality agreements to safeguard all client information throughout the engagement. Our Confidentiality Commitment sets this out in full.
Regulatory & market insightsCan VeroMed provide reliable regulatory and market information to support our entry into Kenya?
Yes. We offer evidence-based regulatory intelligence, competitor landscape reviews, and compliance risk assessments to help you make informed decisions before committing resources.
Quality & brand protection
Quality system alignmentOur internal quality system was designed for another region. Can VeroMed help us align it with Kenya’s expectations?
Yes. We assess your existing QMS, identify gaps against PPB and WHO GxP standards, and support you in adapting SOPs, documentation practices, and operational controls to meet Kenya-specific compliance requirements.
Trademark protectionHow does VeroMed help protect our brand name when entering the Kenyan market?
We conduct trademark searches, assess regulatory naming suitability, and coordinate filings with KIPI. This ensures your brand is protected and avoids conflicts that could delay registration or force rebranding.
Non-compliance risksWhat are the risks if a company does not meet Kenya’s regulatory requirements?
Non-compliance can result in delayed registration and product launches, supply chain disruptions, reputational damage, and regulatory sanctions including, but not limited to, suspension or revocation of licences. VeroMed helps you prevent these risks through proactive compliance planning, quality system alignment, and continuous regulatory oversight.
Kenyan regulatory basics
What is the difference between annual retention and renewal?
Retention is the yearly requirement to keep a registered product active in the PPB database. Missing it means the product cannot be imported, distributed, or sold until retention is completed.
Renewal is the five-year requirement to extend the validity of a Marketing Authorization. Missing it leads to deregistration or removal from the PPB register — the product loses its legal authorization and must undergo a fresh registration process.
How long is a Kenyan Marketing Authorization valid?
Marketing Authorizations are valid for five years. Renewal applications must be submitted at least three months before expiry to maintain continuous authorization and prevent deregistration. We recommend beginning preparation at least twelve months ahead.
Which product categories does PPB regulate, and how are they registered?
PPB regulates medicines, medical devices, cosmetics, supplements, and herbal products. Medicines are submitted via a CTD dossier supported by GMP evidence and a Certificate of Pharmaceutical Product. Supplements and nutraceuticals are registered under PPB’s nutraceutical pathway where no medicinal claims are made. Medical devices and IVDs are classified by risk category A–D and submitted under the Common Submission Dossier Template (CSDT).
All applications are submitted through PRIMS, PPB’s online Pharmaceutical Registration and Information Management System. See the Market Entry Guide →
Who does what between the MAH, the LTR, and the importer?
The MAH holds responsibility for product authorization and compliance. The LTR acts as the regulatory liaison with PPB, ensuring submissions, renewals, and retention are handled correctly. The importer or distributor manages logistics, warehousing, and distribution. Strong collaboration among all three parties ensures smooth market entry and sustained compliance.
Do foreign manufacturing sites need a GMP inspection?
PPB requires compliance with GMP for manufacturing facilities. Foreign sites must undergo a GMP inspection or provide evidence of compliance. Importers must also comply with GSDP for distribution, storage, and cold-chain management. We handle gap analysis, GMP application dossiers, inspection coordination, and follow-up until certification is issued.
Question not answered here? Book a consultation and we will address it against your specific product and portfolio.