Pharmacy and Poisons Board (PPB) has notified pharmaceutical companies and importers that health products whose approval has expired are no longer allowed in the market.
In a notice released on February 5, PPB indicated that only health products with valid approval or those which have made timely applications for renewal are allowed into the market or for sale in the country.
PPB indicated that all medicines and health products need to be approved before they are imported into the country or made available for sale in the market. The approval is valid for five years and needs to be renewed before the expiry date.
Pharmaceutical companies were supposed to have made applications for renewal by December 31, 2025.
As of February 1, 2026, PPB said about 78 per cent of the health products that were on the market last year either have valid approval or had already applied for renewal. However, 22 per cent failed to submit renewal applications on time and are now considered non-compliant.
PPB said those products will not be allowed back into the market unless they go through a fresh registration process.
The Board also said it has already checked all renewal applications that were submitted. Some products have moved to the technical review stage, while others were asked to provide more information.
Companies that received such requests have been given up to 60 working days to respond.
On importation, PPB reminded traders that no health product can be brought into the country without an import licence.
However, to avoid shortages, the Board said products whose renewal applications were submitted on time and cleared during screening can still apply for import licences as the review continues.
PPB said priority is being given to essential medicines, especially those used to manage chronic illnesses and products linked to national health programmes.
On factory inspections, the Board said it is taking a practical approach.
Some manufacturing plants with recently expired Good Manufacturing Practice (GMP) certificates are still being considered, especially where there is a good history and no reports of poor-quality products or recalls.
PPB said inspections will continue based on risk and the importance of the product to public health.
As part of this approach, GMP certification has been extended for several manufacturing sites.
PPB said it will continue engaging industry players to address challenges and improve compliance.
The Board has scheduled a stakeholder meeting on March 4, 2026, at 10.00 a.m., where issues affecting the pharmaceutical industry will be discussed.
PPB, led by Acting CEO Dr Ahmed Mohamed, said the goal is to protect Kenyans by ensuring that medicines in the market are safe, effective and of good quality.
