Legal Notice No. 100 of 2022: Kenya Health Product Registration Rules Explained

Content verification date: October 30, 2026

1. Key takeaways

• Legal Notice No. 100 of 2022 — the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 — is Kenya’s current master registration rules. It was made on June 8, 2022 by the then Cabinet Secretary for Health Mutahi Kagwe, published at pages 684–709 of Kenya Subsidiary Legislation, 2022, under Section 44(1)(d) of the Pharmacy and Poisons Act.
• The Rules contain 17 sections in three parts: Part I (Sections 1–2) title and interpretation; Part II (Sections 3–12) substantive registration rules; Part III (Sections 13–17) miscellaneous: variations, emergency registration, compassionate use, authorization of unregistered products, repeal.
• The subsidiary instruments are the eight forms of the First Schedule (Form 1–Form 8) and the 21 fees of the Second Schedule; fees are in US dollars, with device tiers at USD 100 / 200 / 1,000.
• Section 17 repeals the 1981 Drugs Registration Rules (LN 147 of 1981); since then, drugs, devices, IVDs, vaccines, blood products, cosmetics, food supplements and borderline products fall under one registration instrument.
• Three annual actions bear on devices: retention under Section 8, renewal under Section 9, and variation reporting under Section 13(2).

2. Legal basis

3. Expert insights

Insight 1: One instrument governs eight product families; devices have no standalone provisions

LN 100 of 2022 folds human and veterinary drugs, medical products, medicinal substances, vaccines, diagnostics, medical devices, blood products, traditional and complementary medicine, therapeutic feed and nutritional formulations, cosmetics and related products into the single definition of a health product. The reading here: devices in Kenya have no independent substantive provisions — they share the application, review, retention, renewal and cancellation procedures designed for drugs. This explains why device applications must supply information such as the site of manufacture of active ingredients and batch formula and batch size (Section 8(3)), and why device retention and renewal move on the same rhythm as drugs. Form 4 contains drug-specific fields; devices should enter not applicable with a written explanation, never blank.

Insight 2: Of the 12 categories of accompanying materials under Section 4(3), three most often trip up devices

Section 4(3) requires: (a) proposed labelling; (b) manufacturing licence where applicable; (c) a GMP certificate each from PPB and from the regulator of the country of manufacture; (d) certificates of analysis from PPB-recognized laboratories, if applicable; (e) marketing authorization or registration certificate from the country of sale; (f) quality, safety, effectiveness and performance data in generic technical documentation format; (g) product samples; (k) proof that the applicant holds one of the five licences; and (l) proof of fee payment. Item (c) requires twin GMP certificates, item (g) requires physical samples, and item (e) requires a marketing authorization in the country of sale — three items that impose a real threshold for manufacturers without a prior PPB site inspection, and need scheduling at project kickoff.

Insight 3: Section 5(5) gives applicants a procedural line of defence

Section 5(5) provides that where PPB is not satisfied on quality, safety, effectiveness and performance, or economic value, it may reject the application only after giving the applicant an opportunity to be heard, and must state the reasons in writing. GRZAN’s reading: this is a rare express due-process clause in the Kenyan registration procedure, and companies should use it fully: upon an unfavourable indication of intent, submit written representations promptly and request that specific reasons be stated. This may salvage the application and builds a record for later objection or resubmission.

Insight 4: The emergency provisional certificate under Section 14 is a two-year, duty-laden special channel

Section 14 allows PPB to issue a provisional registration certificate to protect public or animal health or where a threat to life or health exists. Section 14(8) limits its validity to 2 years from issue, or until any declaration under Section 35 of the Public Health Act (Cap. 242) is revoked, whichever comes first; Section 14(6) makes the holder responsible for labelling, packaging, advertising and the pharmacovigilance system. The fee for emergency use authorization of devices and IVDs is USD 2,500. GRZAN’s note: a provisional certificate is not a simplified registration — it carries full vigilance and labelling duties, and on expiry the applicant returns to the ordinary route.

4. Practical recommendations

1. Build a provision-level crosswalk against the 17 sections. Tag every category of accompanying material in the submission checklist with its provision number (for example 4(3)(c)), so deficiencies can be located quickly in clarifications.
2. Schedule the twin GMP certificates and samples early. Fold the acquisition timing of the PPB-side and manufacturing-country GMP certificates into the master timeline, with lead time for international sample shipment.
3. Handle drug-specific fields in Form 4 as not applicable plus explanation. For formulation-related fields in the retention and renewal forms, state the reason field by field to avoid an incomplete-documentation finding.
4. Use the Section 5(5) hearing opportunity fully. Upon an unfavourable indication, apply in writing for a hearing and ask PPB to state specific reasons.
5. Write the 7-day notice into the LAR agreement. Sections 4(4), 14(9), 15(8) and 16(11) all impose a 7-day notice duty for changes to the local representative agreement; the agreement should bind the counterparty to cooperate on notification.
6. Manage provisional certificate projects on a separate ledger. Track the two-year validity, labelling and vigilance duties of Section 14 certificates separately from ordinary five-year certificates.

5. Verification checklist

• □ Does the submission checklist tag every item with the corresponding LN 100 of 2022 provision number?
• □ Have both GMP certificates — from PPB and the country of manufacture’s regulator — been obtained?
• □ Have product sample submission and shipping been arranged?
• □ Are non-applicable drug-specific fields in Form 4 marked as not applicable with explanations?
• □ Does the LAR agreement include the duty to notify PPB within 7 days of changes?
• □ Has certificate validity been confirmed (ordinary 5 years / emergency provisional 2 years)?
• □ Have Second Schedule fees been checked in US dollars (devices USD 100 / 200 / 1,000; EUA USD 2,500)?
• □ Are the expiry points for Section 8 retention and Section 9 renewal recorded in the ledger?

Regulatory information verified as of October 30, 2026.

GRZAN focuses on Kenya, Nigeria, South Africa, Egypt and other African jurisdictions. All external conclusions rely on official gazettes, agency guideline texts and public legal databases, with the verification date stated; unlocatable figures and amounts are marked as practical estimates.

GRZAN services cover: market access strategy and risk classification; preparation and review of registration dossiers (CSDT / STED / 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 clearance and PVoC coordination; regulatory intelligence subscriptions and corporate compliance ledgers.

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