Licensing a New Wholesale Branch in Nakuru

Critical (likely to block licensing):

• Temperature control. A warehouse reaching 34 °C with no air conditioning and no temperature mapping cannot assure storage conditions for medicines labelled 25 °C or below. Mapping of the empty and loaded warehouse across summer and winter profiles, with defined mapping points and a monitoring plan, is the baseline.
• Cold chain. A domestic refrigerator is not a qualified pharmaceutical cold room: it has no alarm, no chart recorder, no fan-forced air circulation, and risks freezing product near the evaporator. No backup power means any outage is an uncontrolled excursion. A validated cold room or qualified pharmaceutical refrigerator with alarm, backup, and a documented excursion SOP is required before insulin or vaccines are stored there.
• Shared loading bay with a food distributor. Food and pharmaceutical storage in the same controlled area without physical separation is unacceptable: pest, dust, spillage, and unauthorised access risks. Physical segregation and controlled access are needed, not a schedule agreement.

Major: no temperature logger in the storage area; no pest control programme; no quarantine/returned-goods/expired-stock area; no written SOPs for receipt, storage, dispatch, returns and recalls.

Minor: signage, documentation formats, training records.

Before the inspection, not after: temperature mapping and monitoring, cold-chain qualification or an explicit decision to exclude cold-chain products from the licence scope, and physical segregation of the loading bay. Anything else can be a condition of licence with a deadline.

The statutory position must be checked against the current Act and Licensing Regulations, but the operating principle is clear: a wholesale dealer licence is held through a named, registered responsible person - normally a pharmacist - who is accountable for quality and for the conditions of the licence. A pharmacy technologist can manage the branch's day-to-day operations, supervise staff and hold delegated responsibilities, but cannot simply be substituted for the statutory responsible person.

What the applicant must demonstrate:

1. A written, signed delegation listing exactly which duties Mr. Kariuki performs and which remain with the responsible pharmacist.
2. Evidence that a registered person with the required qualification is present for the hours the branch actually operates - a monthly visit from Mombasa is not presence. If the branch operates daily, there must be an on-site registered person or a locally based named deputy.
3. Documented monthly visits by the responsible pharmacist with a signed report covering temperature records, stock reconciliation, recalls, complaints and deviations - not a signature in a visitor's book.
4. A quality agreement between the Mombasa head office and the Nakuru branch covering testing, release, complaints, returns and recall execution.
5. An organisation chart and job descriptions showing that Mr. Kariuki has real authority to quarantine stock and refuse dispatch.

Honest advice to the applicant: if the regulations require the responsible person's substantive presence at each licensed premises, the current model will not pass. Either appoint a locally based responsible pharmacist or reduce the branch to a transit depot under a documented arrangement.

Handle it before the inspection. The applicant should submit a notification or application for variation of the licence particulars, disclosing the 40% share transfer with the supporting corporate documents (share transfer instrument, updated register of members, directors' declarations) and confirmation of who now exercises control.

Why it is not a housekeeping matter:

• Licensing is granted to a specific legal entity and, in most frameworks, to specific persons who have been assessed as fit and proper. A change of control means the fitness assessment may no longer reflect who owns the business.
• Most licensing regimes require notification within a defined period of such a change; four months of silence may already be a breach, which is a separate and more serious finding than the change itself.
• An inspector who discovers the change from the corporate documents rather than the application will treat it as concealment and will widen the inspection to the whole licence history.

Risks of non-disclosure: delay or refusal of the Nakuru branch, review of the existing Mombasa licence, conditions imposed on both, and possible enforcement action against the licence holder.

Practical sequence: disclose now, request confirmation of whether the variation can be processed in parallel with the branch inspection, and prepare a short chronology explaining the delay. If the new shareholders include anyone with a regulatory or criminal history relevant to medicines, the applicant should expect a fit-and-proper review before the branch is licensed.