Local Technical Representative vs Importer in Kenya

Foreign pharmaceutical companies entering Kenya often hear two roles used as if they were the same: the local technical representative and the importer. They are not. One represents the product before the regulator; the other moves physical stock into the country and sells it. Confusing them leads to badly drafted distribution agreements, gaps in regulatory responsibility and, sometimes, a manufacturer that cannot change distributors without disrupting its product registrations. This guide explains the difference and how to structure each role.

The Local Representative in the Registration Rules

Every medicine sold in Kenya must be registered. Rule 3 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 prohibits any person from importing, manufacturing or selling a health product in Kenya unless it has been registered under the Rules. The application is made to the Pharmacy and Poisons Board (PPB) under rule 4.

Where the applicant is not a Kenyan citizen, or is a company incorporated outside Kenya, rule 4(2)(b) requires it to appoint a local representative who is a citizen of Kenya, a person with permanent residence, or a company incorporated in Kenya. The register of health products the Board keeps under the Rules records, for each product, both the certificate of registration holder and the local technical representative.

The local technical representative is therefore a regulatory role. It is the Kenyan point of contact for the product’s registration file. In practice, it handles correspondence with the Board, submissions and responses, annual retention under rule 8, renewals under rules 9 and 10, notices of variation under rule 13, and safety reporting and recalls in coordination with the manufacturer.

The Importer and Wholesaler

The importer’s role is commercial and physical. It buys registered products, brings them through customs, stores them and sells them on to pharmacies, hospitals and clinics. To do that lawfully it needs a wholesale dealer’s licence under section 27 of the Pharmacy and Poisons Act (Cap. 244) for each set of premises, with a resident registered pharmacist in control of distribution. Our guide to obtaining a pharmaceutical wholesale licence in Kenya explains those requirements.

An importer does not need to be the local technical representative, and a local technical representative does not need to import. A manufacturer can appoint one Kenyan company as its regulatory representative and sell through several licensed wholesalers.

Why Combining the Roles Can Backfire

Manufacturers often give both roles to one distributor because it is simple. The risk appears when the relationship ends. If the distributor also holds the regulatory relationship for the product, the manufacturer may find that changing distributors means changing its local representative mid-registration, with the cooperation of a party it is in dispute with.

Three drafting points reduce that risk:

• Keep the registration in the manufacturer’s name. The certificate of registration should be issued to the manufacturer or its nominated holder, not to the distributor, with the distributor appointed only as local representative.
• Separate the agreements. Use a distinct local representation agreement alongside the distribution agreement, so one can end without the other.
• Build in a handover. Require the representative, on termination, to cooperate in transferring the role, hand over correspondence and regulatory files, and sign any forms the Board requires.

Our guide to cross-border licensing deals for multinational pharma covers the wider contract law issues.

Choosing a Local Representative

Because the representative speaks for the product before the regulator, its competence matters as much as its commercial reach. Before appointing one, a manufacturer should check that it has qualified regulatory staff, a record of timely submissions, systems for tracking retention and renewal deadlines, and the capacity to handle safety reports and recalls quickly. A missed annual retention can put a product’s place on the register at risk. The agreement should set service levels, reporting duties, confidentiality obligations and the manufacturer’s right to audit.

Exclusivity, Competition and Parallel Imports

Local distributors often ask for exclusivity. An exclusive appointment can be lawful, but restrictions that go beyond what is needed to protect the arrangement may raise issues under the Competition Act, particularly where the manufacturer has a strong market position.

Exclusivity also does not stop every competing import. The Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019 set up a certification process for parallel imports of medicinal substances. Our guide to parallel imports and exhaustion of rights explains what brand owners can and cannot stop.

Controlled Medicines

For narcotic drugs and psychotropic substances, neither role is enough on its own. Import, export and distribution require licences under the Narcotic Drugs and Psychotropic Substances (Control) Act (Cap. 245), and activity outside such a licence falls within that Act’s definition of trafficking. Our guide to importing narcotic and psychotropic medicines into Kenya covers the regime.

Frequently asked questions

This article is general information on Kenyan law as at its publication date, not legal advice. Reading it does not create an advocate and client relationship.