Distribution · Due diligence

What to check before you appoint a distributor in a new market

Before appointing a pharmaceutical distributor, a manufacturer should verify the candidate's quality management system, its designated responsible person, the suitability of its premises, how it qualifies its own suppliers and customers, and whether it will sign a written contract covering training, subcontracting approval and periodic audits, following WHO and EU good distribution practice guidance.

These are not abstract formalities. They are the same criteria that good storage and distribution practice guidelines ask any distributor to meet for any product, in any market, and they give a manufacturer a structured way to compare candidates instead of relying on a sales pitch.

Does the distributor have a working quality system?

It should. WHO guidance on good storage and distribution practices states that entities storing and distributing medical products should have "a comprehensively designed, documented and correctly implemented quality system that incorporates GSP, GDP, principles of quality risk management and management review."¹ EU GDP guidance makes the same point: wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles, and it is the responsibility of the organisation's management, requiring their leadership and active participation.²

Ask to see evidence rather than a policy statement: a system for assessing, controlling, communicating and reviewing risk at each stage of the supply chain, and periodic management review, with minutes available, covering quality metrics, opportunities for improvement and follow-up on earlier recommendations.¹

Who is accountable for quality, and are they empowered to act?

Ask who holds that role by name. WHO guidance calls for a designated person, with appropriate qualification and training, who has the defined authority and responsibility for ensuring a quality management system is implemented and maintained, preferably independent from the person responsible for operations, and free from commercial, political, financial or other pressures that could affect service quality or product integrity.¹ EU GDP is more specific still: the wholesale distributor must designate a responsible person, for whom a degree in pharmacy is desirable, who must be continuously contactable and may delegate duties but not responsibilities. Their listed duties include ensuring suppliers and customers are approved, coordinating recalls, handling complaints, approving subcontracted activities, running self-inspections, and deciding the disposition of returned, rejected, recalled or falsified products.²

Are the premises fit to store your product?

Only if they are designed and run for it. WHO guidance calls for premises that are suitably located, designed, constructed and maintained for receiving, storage, picking, packing and dispatch, with sufficient space, lighting and ventilation for the required segregation, storage conditions and cleanliness, controlled access and security, and, where possible, separate receiving and dispatch bays to avoid mix-ups; products needing specific handling, such as controlled temperature and relative humidity, need appropriate controls and segregation.¹ EU GDP guidance adds that premises should be clean, dry and maintained within acceptable temperature limits, structurally sound and of sufficient capacity, and that contracted premises the distributor does not directly operate should hold their own separate wholesale distribution authorisation.²

How does the distributor vet its own suppliers and customers?

The same rigour you apply to them should apply to who they buy from and sell to. WHO guidance states plainly that medical products should be procured from appropriately authorised suppliers.¹ EU GDP guidance requires a wholesale distributor to obtain supplies only from persons holding a wholesale distribution authorisation, or a manufacturing authorisation covering the product, with supplier qualification performed, documented and periodically rechecked before procurement, and due diligence covering the reputation or reliability of the supplier, offers of products more likely to be falsified, large offers of products normally only available in limited quantities, and out-of-range prices.² The same guidance requires the distributor to supply only to persons who themselves hold a wholesale distribution authorisation or are otherwise entitled to supply to the public, checked through copies of a customer's authorisation, verification against an authority's records, or evidence of entitlement under national law.²

What should a written distribution agreement cover?

More than price and territory. WHO guidance treats delegated distribution as an outsourced activity, to be performed by appropriately authorised parties under a written contract that defines each party's responsibilities and covers, at minimum, compliance with the guideline and with GSP and GDP; each entity's responsibilities for avoiding substandard and falsified products entering the chain; training of personnel; subcontracting subject to the contract giver's written approval; and periodic audits.¹ Before signing, the contract giver, meaning the manufacturer, should assess the contract acceptor, for example through on-site audits, documentation review and a check of licensing status, then provide all relevant product information. In turn, the acceptor should have adequate resources, premises, equipment, personnel, knowledge, experience and vehicles as appropriate, and should refrain from any activity that could adversely affect the products it handles.¹

Does Yemen have its own version of this checklist?

Yes, but the specifics are confirmed case by case rather than published as one fixed list, and much of what circulates online about Yemeni pharmaceutical registration comes from consultancies selling registration services and contradicts itself. Rather than repeat an unverified requirement here, the honest answer is to check directly with a licensed party working in the market. LNJC is a licensed importer and distributor of pharmaceuticals, medical supplies, laboratory equipment, pharmaceutical raw materials and packaging materials in the Republic of Yemen, based in Sana'a, and is glad to walk a manufacturer through what applies to a specific product before any commitment is made. For the broader mechanics of getting goods into the country once a distributor is appointed, see how medical products are cleared for import.

In summary

A distributor is only as good as the systems behind it. Ask for evidence of a working quality system, name the person accountable for it, look hard at the premises, check how the distributor qualifies its own suppliers and customers, and put the relationship in a written contract that covers training, subcontracting and audits. These criteria apply to any candidate distributor in any market, they are a starting point, not a substitute for the fuller set of commercial questions to ask before you choose a partner.