FAQs on Markeing Authorization
All human medicinal products, including prescription medicines, over-the-counter (OTC) drugs, vaccines, herbal and complementary products, biosimilars, and biologicals, require marketing authorization before being sold or distributed in Kenya.
Applicants must submit a dossier (in CTD format), product samples, labeling information, a certificate of pharmaceutical product (CPP), and other documents as outlined in the PPB registration guidelines.
Yes, PPB requires that dossiers for registration of medicinal products be submitted in the Common Technical Document (CTD) format on the PRIMs portal.
Yes, PPB allows reliance or abridged review for products approved by Reference Regulatory Authorities (RRAs) or prequalified by WHO, provided the product is identical and relevant documentation is submitted.
Applicants must submit a CTD-format dossier including preclinical and clinical data, evidence of neutralization activity against local snake species, GMP certification, product samples, and labeling. The product should also meet WHO guidelines for antivenoms.
Marketing authorizations in Kenya are valid for five (5) years and must be renewed 3 months before expiry to maintain the product on the market.
Renewal requires submission of updated safety data, proof of continued quality, payment of renewal fees, and fulfillment of any new regulatory requirements issued since initial approval.
Failure to renew a product may result in suspension of the marketing authorization.
Yes, changes (variations) such as formulation updates, manufacturing site changes, or label modifications must be submitted to and approved by PPB before implementation.Requirements for changes to products granted MA are prescribed in the PPB’s Variation Guidelines.
A variation is a post-approval change made to a registered product’s dossier, which may affect its quality, safety, efficacy, or administrative details. Variations must be reviewed and approved by PPB before implementation.
PPB classifies variations into the following categories:
- Annual Notification (AN): Minor changes with no significant impact, reported within 12 months of implementation.
- Immediate Notification (IN): Minor changes with minimal impact, that may be implemented within 30 days of reporting.
- Minor Variation (Vmin): Changes with limited impact on quality, safety, or efficacy, requiring submission of documentation and approval.
- Major Variation (Vmaj): Significant changes that may affect safety, efficacy, or quality, requiring prior approval before implementation
Submit the appropriate variation application form, supporting documents (e.g., justification, updated dossier sections), and proof of payment through the PPB online portal.
Bioequivalence refers to the absence of a significant difference in the rate and extent of absorption of the active ingredient from two pharmaceutical products; typically a generic and its innovator (reference) when administered under similar conditions.
BE studies demonstrate that a generic medicine is therapeutically equivalent to a reference product, ensuring it will provide the same clinical effect and safety profile, which is essential for marketing authorization.
BE studies must be conducted in compliant clinical research facilities (preferably accredited), with proper study design, validated analytical methods, ethical approvals, and adherence to GCP/GLP standards. The study report should follow the PPB compendium of Guidelines on Medicines Evaluation and Registration in guidelines.
Yes. PPB accepts foreign BE studies, provided they are conducted in accredited facilities and comply with international standards. However, the formulation tested must be identical to the one intended for the Kenyan market.
If a product is not demonstrated to be therapeutically equivalent to the reference product it will not be granted marketing authorization unless reformulated and resubmitted with new