Market entry · Import controls

How medical products are cleared for import: the controls and the paperwork

Before a manufacturer's product reaches a hospital shelf or a laboratory bench in a new market, it has to clear a border. The World Health Organization's guidelines on import procedures for medical products set out the framework that national systems are built on: who is allowed to bring products in, what legal basis backs that control, what paperwork a consignment should carry, and what happens when something looks wrong. Understanding that framework helps a manufacturer read any market, including Yemen, more clearly.

Who is allowed to import

WHO's guidelines are direct on this point: 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 An "importer" is defined as an individual, company or similar legal entity importing or seeking to import a medical product, and a "licensed" or "registered" importer is specifically one granted a licence for that purpose.¹ A separate "import authority", the national agency responsible for authorising imports such as a ministry of trade, may sit alongside the NRA.¹

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

The legal basis for national controls

Subject to specific exemptions, only medical products duly registered or authorised for marketing should be cleared by the relevant authorities.¹ The NRA is expected to publish an updated list of authorised products and authorised importers, and should be empowered to take legal action and work closely with customs, police and the judiciary to detect and stop the import of substandard and falsified products, with confidential channels for sharing that information.¹

Where a country has no formal marketing authorisation system, import is instead controlled through permits issued in the name of the NRA to an authorised importing agent. Within the WHO Certification Scheme, WHO maintains a list of the government organisations authorised to issue a certificate for a medical product (a CPP), which a receiving NRA can use to verify it.¹ The NRA also has discretion to waive authorisation requirements for emergencies, clinical trials, donations, and requests from clinicians for limited supplies of an unlicensed product for a named patient.¹

The paperwork that clears customs

As a prerequisite to clearance, the importing agency or agent should furnish customs with the required documentation for each consignment, except where exemptions apply.¹ The examples given: NRA documents attesting that the importer is duly authorised and the product is duly authorised or permitted to be imported; a batch release certificate from the manufacturer; a safety data sheet, where applicable; and an invoice, bill or delivery slip showing product name, batch number, quantity and expiry date.¹ The list also allows for other documentation required by national or regional legislation, such as a WHO Certification Scheme certificate, and any document the exporting country's competent authority should issue. Exemptions may apply where distribution takes place through regional hubs or by international organisations.¹

What customs actually does with a shipment

On arrival, customs authorities carry out visual examination and preliminary screening, ideally alongside an NRA inspector, checking consignment size against invoices, bills or delivery slips and examining packaging and labelling. Spelling errors, low quality printing and other defects are flagged as possible signs of a substandard or falsified product, and the external package should be intact and free of damage that could change its contents.¹ Sampling and analysis, arranged by the NRA and other authorities, follow a risk-based approach; while samples are analysed prior to release, the consignment is quarantined at an approved site and stored under the conditions on its label, including temperature, light and humidity limits.¹

When something looks wrong

A consignment suspected of being substandard, falsified or not authorised is quarantined pending analysis and forensic investigation, stored under its recommended conditions, with the consignee informed immediately and the authorised manufacturer or importer promptly involved.¹ National or regional regulations define the responsibilities of the NRA, police, border control and ministry of health for the investigation and any legal action, and falsified products, or products imported in contravention of the law, must be forfeited and destroyed or otherwise dealt with under established procedures, with records archived.¹ Confirmed cases are notified without delay to other national or regional authorities and to the WHO Global Surveillance and Monitoring System.¹ Overt and covert technologies, forensic markers, bar coding and other serialisation are named as tools supporting supply chain tracking, among the most prominent preventive measures against substandard and falsified medical products.¹

What this means for entering the Yemen market

This is the international framework, not a country specific checklist, and it will not tell a manufacturer exactly which document Yemen's authority wants on a given shipment or how long clearance takes there. That detail is confirmed case by case with the authority, and a manufacturer is better served asking a licensed importer who does this routinely than guessing from 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 happy to walk a manufacturer through what a specific product category currently requires.

In summary

WHO's import guidelines rest on a simple structure: authorised importers, working through authorised ports, present documentation showing both they and the product are entitled to import, and customs and the NRA check that documentation and the physical consignment before release. Suspect shipments are quarantined, investigated and, where confirmed falsified, destroyed under recorded procedures. Knowing this framework is a useful starting point before asking any distributor, in Yemen or elsewhere, how they actually apply it.

See also: Entering the Yemen market: a manufacturer's guide to distribution, who may import medical products, and what a local representative is for, importing pharmaceutical starting materials and active ingredients, and keeping the cold chain intact from the port to the warehouse.