Kuwait requires Ministry of Health registration and a licensed local agent before any imported medicine reaches a pharmacy or hospital shelf.

Kuwait's Ministry of Health is the single registering authority

Kuwait's Ministry of Health controls which pharmaceutical products can be sold in the country. Registration dossiers are submitted to a dedicated administration, the Medicine and Medical Products Registration and Regulatory Administration, and Ministerial Decree No. 341 of 2025 sets out what a CTD or eCTD registration file submitted to that administration must contain.

Dossiers follow the Common Technical Document format, aligned to the ICH M4 structure across five modules, with a Kuwait-specific Module 1 covering administrative documents, certificates and the manufacturer's letter of authorisation. The scope runs across new chemical entities, generics, biologicals, biosimilars, hormonal products and combination products, so the same framework applies whether the product is an originator brand or a WHO-GMP generic.

See our Kuwait market page for the fuller picture of how registration, pricing and hospital procurement fit together, and our CTD dossier preparation service for how we build the file itself.

Registering a foreign company's products, not the company itself

A foreign manufacturer does not register directly with Kuwait's Ministry of Health. The product is registered through a Kuwaiti entity acting as marketing authorisation holder and local agent, working from a document pack the manufacturer supplies: a legalised manufacturing licence, a legalised Good Manufacturing Practice certificate from the country of origin, and a site master file covering the facility, its equipment and its quality systems.

Manufacturing sites need GMP acceptable to the Kuwaiti and wider Gulf authorities. That is the bar M Care Exports applies before it will offer a molecule out of India: generics come only from WHO-GMP certified manufacturers, and originator brands move through their own licensed Indian marketing channels, so the manufacturing evidence a Kuwaiti registration file needs is already in place before a quote goes out.

Once granted, a registration certificate runs for five years and needs renewal at least six months before it lapses; a product without a current certificate cannot legally be imported, tendered for or dispensed, so the renewal calendar matters as much as the first approval.

Why every shipment needs a licensed Kuwaiti agent

Kuwait does not allow direct-to-market import. Every product needs a local agent: a Kuwaiti company holding a Ministry of Commerce and Industry licence that covers medicine sales, alongside the relevant Ministry of Health drug licence for import and storage. The manufacturer appoints that agent through a legalised letter naming it sole or exclusive agent, and the agency agreement itself is registered under Kuwait's commercial agency law.

The local agent is not a formality. It is the entity that files the dossier locally, holds the import permit, signs for customs, and is the counterparty on any hospital or tender contract. A licence that has lapsed, even briefly, stalls a shipment at the port regardless of how complete the registration dossier is. M Care Exports checks agent licensing status before a first shipment moves, not after.

Our MOH product registration service covers how we work alongside a Kuwaiti agent on filing and renewals.

Where GCC central registration helps, and where it does not

Kuwait is a founding member of the Gulf Health Council, alongside Saudi Arabia, the UAE, Qatar, Bahrain and Oman. The Council runs a central drug registration route through a rotating Central Gulf Committee for Drug Registration, based in Riyadh, letting a single technical dossier be reviewed on behalf of participating states rather than filed separately in each one.

Central approval strengthens a Kuwait filing but does not replace it. Pricing, the local agent appointment, the import licence and Arabic-label approval still run through Kuwait's own Ministry of Health administration at country level. A product with GCC central approval enters the Kuwait queue in a stronger position; it does not skip the queue.

Our note on WHO prequalification versus national registration covers the same reliance-versus-national-filing question from a different angle, and is worth reading alongside this one.

How Kuwait's public sector buys medicines

Kuwait's Ministry of Health owns and runs most of the country's hospitals and polyclinics, and buys the medicines that stock them. Storage and distribution to those facilities runs through the Central Medical Stores Administration, the Ministry's dedicated warehousing and distribution arm. Procurement itself runs two ways: medicine-specific tenders are published and run through the Ministry's own electronic tenders channel, while larger, cross-ministry contracts route through Kuwait's Central Agency for Public Tenders, the state body responsible for government-wide tendering.

Either way, the Ministry evaluates the registration status of the offered brand alongside price. A tender response needs a current registration number, Certificate of Analysis, Certificate of Origin, GMP certificate, stability data and Arabic-approved artwork ready before the tender opens, not assembled after an award.

See our GCC tender response service for how we prepare that pack.

The document pack an Indian exporter prepares

From the Indian side, a Kuwait registration file typically draws on: the manufacturer's CDSCO or state drug-licensing authority manufacturing licence, a WHO-format Certificate of Pharmaceutical Product or free sale certificate, the current GMP certificate, a Certificate of Analysis for the specific batch, stability data, and, where the product needs one, a Drug Master File for the active ingredient.

Kuwait has not joined the Hague Apostille Convention, so these documents cannot simply be apostilled. They need consular legalisation instead: attestation through India's Ministry of External Affairs, followed by legalisation at the Kuwait Embassy in New Delhi, before the Kuwaiti agent can submit them to the Ministry.

M Care Exports assembles this pack from its Mumbai regulatory desk and routes the legalisation steps directly, so the file that reaches the Kuwaiti agent is ready to submit rather than needing a second round of corrections. If you are evaluating a specific molecule, tell us what you need or open a trade account to start the conversation.

Frequently asked

Who actually registers a medicine with Kuwait's Ministry of Health, the exporter or the local agent?

The filing is made by the Kuwaiti local agent, working from documents the exporter supplies. A foreign manufacturer has no direct standing to register a product in Kuwait; it appoints a Kuwaiti company as marketing authorisation holder and local agent, and that company submits the Common Technical Document dossier, holds the import licence, and is the entity the Ministry of Health corresponds with. The exporter's job is to supply a complete, correctly legalised document pack, so the agent's filing goes through without deficiency queries.

Does GCC central registration mean I don't need to register separately in Kuwait?

No. Kuwait is a founding member of the Gulf Health Council's central drug registration route, and a centrally reviewed product enters Kuwait's own queue in a stronger position. But pricing, the local agent appointment, the import licence and Arabic-label approval still have to be completed through Kuwait's Ministry of Health at country level. Central registration speeds and strengthens the technical review; it does not replace the national filing.

What licences does a Kuwaiti import agent need to hold?

A Ministry of Commerce and Industry licence that specifically covers medicine sales activity, plus the relevant Ministry of Health drug licence covering import and storage. The agency agreement between the manufacturer and the agent is registered under Kuwait's commercial agency law, and the agent's authorised signatures need to be legalised through the Kuwait Chamber of Commerce and Industry. If either licence lapses, shipments stall at the port even when the product's own registration is current.

Can I send Kuwait an apostilled document instead of a legalised one?

No. Kuwait has not joined the Hague Apostille Convention, so an apostille is not accepted for documents used there. Manufacturing licences, GMP certificates and other supporting documents need consular legalisation instead: typically attestation through India's Ministry of External Affairs, followed by legalisation at the Kuwait Embassy in New Delhi. Building this into the production schedule early avoids it becoming the item that delays a filing that is otherwise ready.

How does Kuwait's public sector actually buy medicines?

Kuwait's Ministry of Health owns most of the country's hospitals and polyclinics and buys directly. Medicine-specific tenders run through the Ministry's own electronic tenders channel; larger, cross-ministry contracts go through the Central Agency for Public Tenders. Successful suppliers deliver into the Central Medical Stores Administration, the Ministry's central warehousing and distribution arm, which then supplies individual hospitals and health centres. A current registration number is a precondition for bidding, not a detail to sort out after an award.

Can M Care Exports supply both branded and generic medicines into Kuwait?

Yes. M Care Exports supplies originator brands through licensed Indian marketing channels and generics sourced from WHO-GMP certified Indian manufacturers, both against the same Kuwait registration and local-agent framework. M Care Exports does not manufacture and does not hold WHO-GMP itself; it is a merchant-exporter that builds the registration and shipping file around whichever product, branded or generic, a Kuwaiti buyer actually needs, and sources the manufacturing evidence from the plant that made it.