Kenya Donated and Unregistered Products: Form 8 and Reporting Duties

Content verified on: October 30, 2026

1. Key takeaways

• The application fee for donated health products is USD 0 (Second Schedule, LN 100 of 2022) — the only expressly zero-rated application channel.
• Regulation 16 provides the import or distribution authorisation for unregistered health products, applied for on Form 8.
• Regulation 16(7) sets three reporting duties: progress reports every 6 months, immediate reporting whenever an adverse event occurs, and a progress report within 30 days of use being completed or terminated.
• Regulation 16(12) states expressly that donated health products and technologies are governed by regulation 16 — a zero application fee does not mean zero duties.
• Regulation 15 on compassionate use requires products to be supplied free of charge during the certificate period, with continued supply for at least 1 year after the certificate expires.
• Regulation 13(2) requires reporting of quality and safety changes or defects in marketed products that may affect patient safety, as well as marketing or regulatory decisions in the country of origin or other countries of sale.

2. Legal basis

3. Expert insights

Insight 1: Behind the zero-fee channel sits the densest set of reporting duties

The application fee for donated products is USD 0, yet regulation 16(12) places donated products squarely inside the authorisation and reporting framework of regulation 16. GRZAN judges that the fee design reflects access facilitation while the reporting duties reflect risk control, and the two do not offset each other. Donations tend to arrive in bulk, close to expiry and distributed through non-commercial channels, so the exposure is actually higher than for routine commercial imports — which is why the reporting density increases rather than decreases.

Insight 2: The 6-month periodic report and the 30-day final report are two clocks running in parallel

Regulation 16(7) sets both a periodic clock and an event-driven clock: the former triggers every 6 months, the latter once within 30 days of use being completed or terminated, and on top of both sits the duty to report adverse events immediately. GRZAN notes that the final report does not replace the periodic reports: if the period of use spans several 6-month milestones, each periodic report in between must still be filed. Project scheduling should carry both sets of reminders and state clearly whether the licence holder or the Local Authorized Representative (LAR) bears the submission duty.

Insight 3: Free supply does not lighten quality and vigilance responsibilities

Regulation 15(5) requires compassionate use products to be supplied free of charge during the certificate period, with continued supply for at least 1 year after expiry; regulation 13(2) requires reporting of changes or defects that may affect patient safety and of foreign regulatory decisions. GRZAN reads the two provisions together as establishing a dual duty of supply continuity plus reportable safety. Free of charge is not a defence: donor and authorisation holder must still maintain distribution records, complaint handling and adverse event reporting procedures (Article 7 of the Submission Document Guidelines).

Insight 4: The connection to the traceability system is tightening the threshold

The National Authentication and Traceability System went live on August 3, 2026 and is planned to transition to full serialization on January 1, 2027, making batch-level data a pass-through requirement. Goods under donation and unregistered product authorisation enter the same chain. GRZAN recommends defining batch identification and destination record standards already at the authorisation application stage, because retro-fitting them afterwards costs far more than planning before shipment (the detailed interface requirements follow PPB’s subsequent formal notices — a practical estimate).

4. Practical recommendations

1. Build a reporting calendar. GRZAN recommends setting a periodic report reminder every 6 months from the authorisation effective date, plus a final report reminder for 30 days after completion.
2. Fix the submitting entity. State in the authorisation documents and the internal responsibility matrix whether the licence holder or the LAR files the reports, so that neither clock is left unattended.
3. Pre-set the adverse event channel. Build an immediate-reporting trigger and escalation mechanism for adverse events, sharing one entry point with the vigilance system.
4. Plan batch data ahead. Fix batch identification and destination record standards for donation and authorisation goods before shipment, aligned with the traceability system.
5. Assess supply continuity. For compassionate use projects, plan capacity and inventory on the basis of continued supply for at least 1 year after expiry.
6. Archive the full evidence set. File authorisation documents, progress reports, adverse event reports and disposition evidence by project number for retrieval at renewal or inspection.

5. Verification checklist

• □ Has it been confirmed that the application fee for donated health products is USD 0 and that regulation 16 applies?
• □ Was the import or distribution authorisation for unregistered products applied for on Form 8?
• □ Is a periodic progress report reminder set for every 6 months from the authorisation effective date?
• □ Is a final report reminder set for 30 days after completion of use?
• □ Is an immediate reporting trigger and escalation mechanism for adverse events in place?
• □ Are batch identification and destination record standards aligned with the traceability system?
• □ Has capacity been modelled for compassionate use projects on the basis of continued supply for at least 1 year after expiry?
• □ Are authorisation documents, progress reports and adverse event reports archived by project number?

Regulatory information verified as of October 30, 2026.

In African markets, the GRZAN regulatory team focuses on jurisdictions such as Kenya, Nigeria, South Africa and Egypt and runs a verification mechanism built on primary regulatory sources: every regulatory conclusion it publishes relies solely on official gazettes, the original texts of regulator guidelines and public legal databases, each marked with a verification date. Any figure, timeline or amount that cannot be located in an official source is flagged as a practical estimate rather than an assumption.

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