Importing unregistered medicines into Russia, Kazakhstan and Uzbekistan

Russia, Kazakhstan and Uzbekistan share a regulatory heritage, Russian is widely used for documents in all three, and each requires a Ministry of Health decision before an unregistered medicine enters. The details now diverge. Russia and Kazakhstan run fast electronic conclusion procedures with short published deadlines, while Uzbekistan relies on Ministry orders, a published list and mandatory certification, with fewer fixed timelines.

This guide compares the three countries. The country guides for Russia, Kazakhstan and Uzbekistan contain the full routes, documents, worked timelines and sources.

The three routes at a glance

Russia and Kazakhstan are members of the Eurasian Economic Union. National registrations in both had to move to common EAEU rules by 31 December 2025, with extensions reported for dossiers already in progress. Uzbekistan is not a member, so EAEU registrations do not apply there.

Russia: a conclusion for a specific patient

Federal Law 61-FZ, Article 47, requires imported medicines to be on the State Register, with listed exceptions. The procedure sits in Government Decree 853 of 1 June 2021. A Russian medical organisation, or another eligible legal entity such as a wholesaler, applies through the Ministry of Health's electronic service on Gosuslugi.

The core of the file is a medical commission or federal consilium protocol naming the medicine, form, dose and quantity, with a copy of the patient's passport or birth certificate, a justification of the quantity and the supply contract. The Ministry decides within 5 working days and charges no fee, and the conclusion does not expire. After the hospital receives the medicine, the importer notifies the Ministry within 10 working days.

Separate procedures cover groups of patients with rare or severe conditions, named in a Government act, and clinical trial batches. A Ministry draft would replace Decree 853 from 1 September 2027, so check the current rules before relying on an older checklist. Narcotic and psychotropic medicines follow separate permits.

Kazakhstan: a conclusion within 3 working days

The Committee for Medical and Pharmaceutical Control (KMFK) issues import conclusions for unregistered medicines. Its service page confirms that applications are made electronically and decided within 3 working days.

The clinical side comes first. Under Order KR DSM-280/2020, the healthcare organisation's council of doctors must conclude that registered alternatives are ineffective or cannot be used, and the patient or a legal representative gives written informed consent. The import file then adds a quantity calculation, a letter from the regional health authority, the contract or invoice and quality documents translated into Kazakh or Russian, the GMP certificate and proof of registration in the country of manufacture. The applicant commits to adding a sticker and instructions in Kazakh and Russian.

Order 62 of 1 July 2025 limited each conclusion to the calendar year in which it is issued and requires a report on its use within 15 calendar days after it expires. Late-year approvals therefore leave little time to ship.

Uzbekistan: orders, a list and certification

Uzbekistan's Law on Medicines and Pharmaceutical Activity prohibits imports of unregistered medicines except where the law allows them. Three openings matter:

• Ministry order. Article 24 lets orphan medicines, and products for particularly dangerous or epidemic infections, be imported without registration when the Ministry of Health orders it. No form or timeline is published.
• The 2025 list. In March 2025 the Ministry approved a list of 34 medicines and 117 medical devices with no registered equivalent, which may be imported and used without registration if they pass mandatory certification. The order runs until 1 January 2028.
• One course of treatment. Article 25 lets medicines enter for a patient on an indication confirmed by a medical institution, within one course of treatment. It reads as a personal route, so confirm how a shipment from a foreign supplier would clear before relying on it.

A new registration resolution of November 2025 includes registration by recognition of foreign approvals, which suits a medicine needed regularly rather than for one patient. A December 2025 draft would also create a fast track for scarce medicines.

Documents to prepare in India

The exporter's documents are similar in all three countries, but the language and the level of detail differ. Kazakhstan expects the contract or invoice and the quality documents translated into Kazakh or Russian, plus GMP evidence and proof of registration abroad. Russia's patient conclusion relies on the medical protocol rather than on quality documents, but importers and customs still work from a matching proforma invoice, commercial invoice, packing list and certificate of analysis for each batch. Uzbekistan's certification step looks at the product itself, so the certificate of analysis, GMP certificate and proof of registration abroad should travel with the goods.

In every case the product name, strength, pack size and quantity must be identical on the clinical file, the conclusion, the invoice and the air waybill. Products that are unapproved or new in India can also need export permission on the Indian side, as explained in Indian export rules buyers should know.

Shipping, payment and taxes

Global express networks suspended Russia services in 2022, so small parcels move through specialist forwarders, usually via Dubai or Istanbul. IndiGo resumed Mumbai flights to Almaty and Tashkent in September 2025, four times a week each, which helps cold-chain lanes to Kazakhstan and Uzbekistan. For 2 to 8°C products, plan packaging qualified for at least 120 hours. The cold-chain transit checker compares packaging and transit time.

Payment is often the slowest step for Russia. Medicines are generally carved out of the main Western sanctions programmes, and OFAC General License 6 authorises transactions incident to exporting medicine to Russia, but banking remains harder. In June 2026 Pharmexcil asked Indian exporters to report payment problems in Russia trade. Screen every party and agree the bank route before production, as covered in how to pay for an international medicine order.

Step by step: a named-patient import from India

1. Confirm the route and applicant: a Russian medical organisation or wholesaler, a Kazakh healthcare organisation or importer, or an Uzbek hospital or licensed importer.
2. Ask the supplier in India for product details, a proforma invoice, the certificate of analysis, GMP evidence and a certificate of pharmaceutical product where needed.
3. Prepare the clinical file: the medical commission protocol in Russia, or the council of doctors conclusion, consent and regional letter in Kazakhstan.
4. Arrange translations into Russian or Kazakh, and Kazakh and Russian labelling stickers where required.
5. File for the conclusion or confirm the Ministry order or listing in Uzbekistan.
6. Agree payment, then ship under FCA, CIP or DAP to the main gateway, since DDP is rarely practical when the local applicant holds the permit.
7. Clear customs, complete certification in Uzbekistan, and send any notice of receipt or usage report on time.

The lead-time estimator gives a planning range for each country, and the document checklist tracks the files.