22% of Health Products Risk Deregistration After Missed Renewal Deadline

The Pharmacy and Poisons Board (PPB) has issued clarifications on a variety of areas relating to the implementation of health products and technologies (HPTs) renewal of authorization, control of import, as well as inspections, in which products that are not compliant risk losing their status in Kenya.

In the notification published under the Ministry of Health, the Board reaffirmed its mandate under the Pharmacy and Poisons Act, CAP 244.

They noted their mandate as being the primary responsibility to “protect and promote public health by ensuring access to quality, safe, and efficacious Health Products and Technologies (HPTs).”

According to the Board, Section 3A(c) of CAP 244 empowers it, “to grant, vary, renew or withdraw marketing authorization for HPTs, subject to prescribed conditions.”

It further reminded stakeholders that under the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, “any person intending to import, manufacture, or distribute an HPT must obtain prior registration of the product from the Board.”

Expired Authorizations Lose Legal Status

The PPB stressed that certificates of registration or renewal are valid for five years, noting that “any HPT whose Marketing Authorization expires without submission of a renewal application ceases to have lawful registration status and is ineligible for importation, manufacture, or distribution in Kenya.”

To enforce compliance, the Board directed that all holders of expired or expiring authorizations submit renewal applications by 31 December 2025.

As at 1 February 2026, the Board reported that, “78% of the 9,551 HPTs that were retained and in circulation in 2025 either hold valid Marketing Authorizations or have submitted renewal applications currently under regulatory review.”

However, the remaining products face serious consequences.

“The remaining 22% of HPTs whose renewal applications were not submitted by the stipulated deadline are therefore non-compliant with the statutory and regulatory requirements,” the notice states, adding that such products are required to undergo fresh registration in accordance with the applicable regulatory procedures.”

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Screening, Importation and Priority Products

The Board disclosed that all renewal applications submitted by 1 February 2026 have been screened for completeness.

Applications have either “progressed to technical evaluation or been issued with requests for additional information to assure continued product Quality, Safety, and Efficacy.”

Stakeholders issued with screening queries have been instructed to respond promptly, with the Board indicating it will “complete screening phase within sixty (60) working days from the date of submission.”

On importation, the Board was categorical that “Rule 3 of the Pharmacy and Poisons Rules, 2022, prohibits importation of any HPT into Kenya without a valid import License issued by the Board.”

It added that to ensure continuity of essential medicines, “applications that were submitted before the expiration of the period indicated in Rule 10(1), may apply for import License,” with priority given based on “public health risk, therapeutic importance, and alignment with national public health programmes.”

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GMP Inspections and Stakeholder Engagement

On manufacturing oversight, the Board said it has adopted a risk-proportionate approach, allowing regulatory consideration of sites with recently lapsed GMP certification where there is “documented historical compliance, absence of reported quality defects and product recalls.”

GMP inspections, it noted, are conducted based on “risk prioritization, product criticality, and public health impact,” with some manufacturing sites granted extended certification status.

To enhance compliance, the Board announced a stakeholder engagement session scheduled for 4 March 2026 at 10.00 a.m.

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Pharmacy and Poisons Board (PPB) Acting CEO Dr Ahmed Mohamed speaking during the Pre-Conference Industry Day of the 7th Biennial Scientific Conference on the Regulation of Medical Products in Africa (SCoMRA VII), held in Mombasa on November 11, 2025. PHOTO/PPB.