Market entry · Local representation

Who may import medical products, and what a local representative is for

A manufacturer entering a new market is usually told, quickly, that it needs "a local representative" or "an authorised importer." Those terms get used loosely. WHO's guidelines on import procedures for medical products and the EU's Good Distribution Practice guidelines both describe, precisely, what that role is meant to do and why it exists. Reading those definitions first makes it much easier to judge a prospective partner anywhere, including Yemen.

The basic rule: only an authorised importer may bring products in

WHO's guidelines are direct: import should be undertaken by an importer or agency authorised by the national regulatory authority (NRA), in line with national and regional legislation, and this normally excludes products simply in transit.¹ National and regional guidelines on how to apply that legislation are meant to be drawn up by the NRA, or by the ministry of health where no NRA is formally established, in collaboration with the customs authority and other responsible bodies.¹

Import is expected to be channelled exclusively through customs posts or ports specifically authorised for the purpose, a rule that extends to products moving through international e-commerce.¹ All the formalities on importation are meant to be coordinated between customs, border control, the NRA and the ministry of health as relevant, with NRA officials stationed full time at busy ports where the workload justifies it, and WHO is explicit that the impact of delays on access to medicines and on storage conditions should be taken into account when this is organised.¹

Why a permit issued to a local agent matters so much

WHO's guidelines describe two different situations. Where a country has a formal system of product marketing authorisation, only products duly registered or authorised for marketing should be cleared, and the NRA is expected to publish an updated list of authorised medical products and of the importers permitted to bring them in, with close collaboration needed to verify, case by case, that a product is authorised and free of restrictions or withdrawals.¹

Where no formal marketing authorisation system has been established, WHO's guidelines say import is instead most effectively controlled by the NRA issuing permits, in its own name, to the authorised importing agency or agent.¹ In practice, that permit is what makes the local partner the lawful channel through which a manufacturer's product can enter the country at all. WHO also maintains, within its Certification Scheme, a list of the government organisations authorised to sign and issue a certificate of a medical product (a CPP), which a receiving NRA can use to check that a certificate was actually issued by the right body, and names further measures such as the NRA supplying customs and the importing agency with official lists of permitted or prohibited products, and the importing agent providing certified information that a product is licensed for sale in its country of export.¹

NRAs are also expected to be empowered to take legal action, and to work closely with customs, police and the judiciary to detect and prevent the import of substandard and falsified products, with confidential channels for sharing that information between the responsible bodies.¹ Separately, the NRA retains discretion to waive product authorisation requirements for emergencies, clinical trials, donations, and requests from clinicians for a limited supply of an unlicensed product for a specific named patient.¹

What good distribution practice expects of the partner itself

Being the authorised channel is the legal side of the relationship. The EU's Good Distribution Practice guidelines describe the operational discipline meant to sit alongside it. They state that a wholesale distributor receiving medicinal products from third countries for importation must hold a manufacturing authorisation covering that activity, and that wholesale distributors generally must obtain supplies only from persons who themselves hold a wholesale distribution authorisation or a manufacturing authorisation covering the product. Where a product is obtained through brokering, the receiving distributor must verify that the broker is registered and complies with the applicable requirements.²

Qualification and approval of suppliers, the guidelines say, should be performed before any procurement, controlled by a written procedure, with the results documented and periodically rechecked. When entering into a new contract with a new supplier, they call for "due diligence" checks on that party's suitability, competence and reliability, with attention to the reputation or reliability of the supplier, offers of medicinal products more likely to be falsified, large offers of products normally available only in limited quantities, and out-of-range prices.² The obligation runs the other way too: a wholesale distributor must supply medicinal products only to persons who themselves hold a wholesale distribution authorisation, or who are otherwise entitled to supply medicinal products to the public, with periodic rechecks that may include requesting copies of a customer's authorisation or verifying its status on an authority's website.²

Put side by side, WHO's guidelines establish who is legally entitled to bring a product across a border, including the permit that makes this possible where no formal marketing authorisation system exists, while the EU GDP guidelines describe what a properly run distributor then does with that standing: qualifying its own suppliers and customers, documenting the checks, and treating unusual offers or pricing as a warning sign rather than an opportunity. A manufacturer evaluating a prospective partner can reasonably ask to see both, the authorisation that makes the partner a lawful importer, and the internal procedures that show suppliers and customers are actually qualified and rechecked rather than assumed.

What this means for entering the Yemen market

These are international frameworks, not a Yemen specific checklist, and neither one will tell a manufacturer exactly which permit or document Yemen's authority currently expects, or how a specific local representative arrangement is structured there. That detail is confirmed case by case with the authority. A manufacturer is better served asking a licensed importer that already operates in the country than relying on a general guideline or a third-party summary. 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 the exclusive distributor there, under signed agreements and for the products named in those agreements, for Shivani Scientific Industries Pvt. Ltd. (India) and Zhanjiang Bokang Marine Biological Co., Ltd. (BOKANG BIO, China). We are happy to explain, plainly, what the current arrangement looks like for a given product category.

In summary

Import authorisation and local representation rest on two linked ideas: a permit or authorisation that makes a partner the lawful channel for bringing a product into a country, and a set of supplier and customer qualification checks that a properly run distributor documents and repeats over time. Ask any prospective partner, in Yemen or elsewhere, to show both, and treat vague answers on either one as a reason to look further.

If you are weighing up how to enter the Yemen market more broadly, see how medical products are cleared for import for the border side of this same framework.