Kenya Fast Track Review and Emergency Use Authorization: Fees and Temporary Certificates

Content verified as of October 30, 2026

1. Key takeaways

• Expedited review is open to Class B and Class C/D products under PPB guideline HPT/PER/GUD/041; the fee is USD 2,000 for expedited review of health products not manufactured in Kenya.
• The fee for an Emergency Use Authorization (EUA) for medical devices and in vitro diagnostics is USD 2,500, running in parallel with rather than in place of the regular registration fee.
• Section 14 governs provisional registration certificates in emergency situations, applied for on Form 2; overseas applicants must appoint a local representative, and any change to the representative agreement must be notified to PPB within 7 days.
• Section 14(8): a provisional certificate is valid for 2 years from the date of issue, or until the declaration under Section 35 of the Public Health Act (Cap. 242) is revoked, whichever comes first.
• Regular registration certificates are valid for 5 years (Section 10(1) and guideline Section 2.12); in emergency or public interest situations PPB may issue certificates valid for 2 years.
• Section 14(6): the provisional certificate holder bears responsibility for labeling, packaging, advertising and the pharmacovigilance system; obligations are not reduced because of the emergency.

2. Legal basis

3. Expert insights

Insight 1: The two fast channels are of entirely different natures

Expedited review is a process acceleration: the same dossier and the same standards, only earlier in the queue, producing a regular registration certificate. An emergency use authorization is a change in the form of access: it produces a provisional registration certificate whose very existence presupposes the emergency itself. Confusing the two produces misjudgments in both directions: assuming that an EUA completes regular registration, or assuming that applying for expedited review relaxes the evidence requirements. GRZAN’s assessment: an EUA answers whether the product may be used temporarily, while regular registration answers whether it may be sold long term. The two must be advanced in parallel.

Insight 2: Two years and five years are not a shortened version of each other

Section 10(1) gives regular certificates a 5-year validity and Section 14(8) gives provisional certificates 2 years, and guideline Section 2.12 adds that certificates valid 2 years may be issued in emergency or public interest situations. The key is the second limb of Section 14(8): the provisional certificate runs only until the declaration under Section 35 of Cap. 242 is revoked, whichever comes first. The 2 years is a ceiling, not a promise. Once the public health declaration is revoked, the certificate lapses immediately, even if issued a month earlier. A company that builds inventory and tender arrangements on the full 2 years carries exposure to early lapse of the certificate.

Insight 3: The four responsibilities of a provisional holder carry no discount

Section 14(6) places responsibility for labeling, packaging, advertising and the pharmacovigilance system squarely on the certificate holder. The provision rejects the reading that emergency means exemption: what the provisional license relaxes is the intensity of premarket review, not the intensity of post-market obligations. Overseas applicants must also observe the 7-day notice duty for the appointment of, and any change to, the local representative. The Local Authorized Representative (LAR) is PPB’s contact and enforcement handle during an emergency; an unreachable representative means obligations that cannot be performed.

Insight 4: The fee structure needs to be calculated on an additive basis

In the Second Schedule, the EUA is USD 2,500, expedited review of health products not manufactured in Kenya is USD 2,000, regular Class C/D registration is USD 1,000 and Class B is USD 200. These items are listed separately, which shows that they are independent, stackable application matters. GRZAN’s note: budgets should not be built on an EUA-replaces-registration basis but on an EUA-plus-regular-registration basis, and if acceleration is genuinely needed, the USD 2,000 for expedited review must be added as a separate line. Donated products carry an application fee of USD 0 but fall under the reporting obligations of Section 16, making that a separate channel.

4. Practical recommendations

1. Run both channels in parallel. Initiate the EUA and the regular registration at the same time; never substitute the provisional certificate for long-term registration.
2. Schedule on a whichever-comes-first basis. Roll supply chain and tender plans forward on cycles shorter than 2 years.
3. Appoint and lock in the local representative. Overseas applicants must appoint one and notify PPB within 7 days of any agreement change.
4. Operate vigilance normally during the provisional period. Assign the labeling, packaging, advertising and pharmacovigilance responsibilities under Section 14(6) to named owners and logs.
5. Budget on an additive basis. Include USD 2,500 EUA, USD 1,000 regular registration and, where applicable, USD 2,000 expedited review.
6. Prepare the full regular dossier in advance. When the provisional certificate expires or the declaration is revoked, the regular route should take over seamlessly.

5. Verification checklist

• □ Has it been confirmed whether expedited review (HPT/PER/GUD/041) or Section 14 provisional registration applies?
• □ Has the overseas applicant appointed a local representative and acknowledged the 7-day change notice duty?
• □ Is the 2-year ceiling of the provisional certificate understood on a whichever-comes-first basis?
• □ Are the four Section 14(6) responsibilities (labeling, packaging, advertising, vigilance) assigned to named owners?
• □ Is the budget built additively (USD 2,500 plus USD 1,000 plus USD 2,000)?
• □ Is the regular registration scheduled in parallel under the 5-year validity framework?
• □ Is a continuity and stock disposition plan in place for the lapse of the provisional certificate?

Regulatory information verified as of October 30, 2026.

Across African markets, the GRZAN regulatory team focuses on jurisdictions including Kenya, Nigeria, South Africa and Egypt, and operates a verification mechanism built on primary regulatory sources: every regulatory conclusion published externally rests solely on official gazettes, the original text of competent authority guidelines and public legal databases, each marked with its verification date. Any figure, timeline or amount that cannot be located in an official source is labeled as a practical estimate and never presented as an assumption.

GRZAN services cover market access strategy and risk classification assessment; preparation and review of registration dossiers in CSDT, STED and CTD formats; selection and management of Local Authorized Representatives (LAR); quality management system and GMP/GSDP compliance support; post-market vigilance, change management and recall response; import customs clearance and PVoC coordination; and regulatory intelligence subscription with corporate compliance record-keeping.

For a Kenya market access plan tailored to your specific product, contact the GRZAN regulatory team at info@grzanglobal.com.