Importing medicines into Russia

The regulator

The Ministry of Health of the Russian Federation (Minzdrav) keeps the State Register of Medicines and issues the conclusions, in effect permits, needed to import unregistered medicines. Its public service for import conclusions covers trial batches, registration samples, research batches and batches for a specific patient or a limited group of patients with rare or particularly severe conditions. The Federal Service for Surveillance in Healthcare (Roszdravnadzor) supervises medicines once they circulate in Russia.

Russia is a member of the Eurasian Economic Union (EAEU). National registrations had to be brought into line with the common EAEU rules by 31 December 2025, with extensions reported for dossiers already in the alignment procedure. A medicine banned anywhere in the EAEU cannot be imported on a patient conclusion.

Legal routes for unregistered medicines

Federal Law 61-FZ, Article 47, requires imported medicines to be on the State Register, with listed exceptions. The procedure is set by Government Decree 853 of 1 June 2021, in force until 1 September 2027.

A specific patient's vital needs

A Russian medical organisation or another eligible legal entity applies through its Gosuslugi account with an electronic signature. The file includes a draft conclusion, a justification of the quantity, the supply contract where two or more parties are involved, a medical commission or federal consilium protocol naming the medicine, form, dose and quantity, and a copy of the patient's passport or birth certificate. A decision of the Krug Dobra foundation's expert council can stand in for the protocol. Quality documents are not required for this category. The Ministry decides within 5 working days, charges no fee and issues a conclusion that does not expire. After delivery, the importer notifies the Ministry within 10 working days. A protocol already used for one conclusion cannot be reused unless therapy is lifelong or long term.

Rare and particularly severe conditions

For a limited group of patients, a Government act names the importer, the medicines, forms, doses and volumes. The named importer files within 3 working days of the act, and the same review applies. Brace Law Firm lists the grounds for refusal: an applicant that is not entitled, incomplete or unreliable data, or a medicine banned in the EAEU. A refused applicant can file again after fixing the problem.

Trials, foreign packaging and personal use

Clinical trial batches need their own conclusion with packaging marked for trial use only. Registered medicines in packaging meant for other markets may circulate during a sanctions-linked shortage, a regime that Federal Law 483-FZ extended to 31 December 2027 after 494-FZ had carried it to the end of 2025. Decree 853 also exempts medicines that arriving individuals bring for personal use, with prescription documents for potent substances. That exemption does not set out a route for a foreign supplier to ship to a patient's home.

Changes ahead

A Ministry of Health draft would replace Decree 853 from 1 September 2027. The chair of the medical commission would sign the protocol, and a protocol issued for the full volume could not be reused except for lifelong therapy. Public discussion closed on 18 September 2026 and the draft had not been adopted when this page was written.

Documents a buyer usually needs

• Ministry of Health conclusion for the specific batch, issued to the Russian applicant
• Medical commission or federal consilium protocol and a copy of the patient's identity document
• Justification of the quantity and the supply contract
• Proforma invoice, commercial invoice and packing list with matching names and quantities
• Certificate of analysis for each batch
• Russian customs declaration filed by the importer or its broker
• Air waybill, then the notice of receipt to the Ministry

Timeline: a worked example

A regional hospital needs an unregistered orphan medicine for one patient, with a licensed Russian wholesaler acting as importer.

Total: roughly 4 to 10 weeks from request to delivery, with payment the least predictable step. These are planning estimates, not published service times.

Shipping lanes from India

DHL, UPS and FedEx suspended Russia deliveries in March 2022, so express door-to-door service is limited and depends on the forwarder. Small parcels usually move with a specialist forwarder in about 5 to 10 days. Air cargo from Delhi or Mumbai to Moscow, mostly through a hub such as Dubai or Istanbul, is usually 7 to 14 days including clearance. Cold-chain and controlled lots should move as air cargo with the conclusion in place before departure.

FCA, CPT or CIP to a Moscow airport are the usual terms, and DAP works when the Russian importer appoints the customs broker. DDP is rarely practical because the Russian applicant holds the conclusion and clears the goods.

Practical tips for buyers

• Agree the payment route before production. Medicines are generally carved out of the main Western sanctions programmes, for example OFAC General License 6 authorises transactions incident to exporting medicine to Russia, but banking is still harder. In June 2026 Pharmexcil asked Indian exporters to report payment problems in Russia trade for review by the Department of Commerce.
• Duty on retail-packed medicines under EAEU code 3004 90 000 2 is 3 percent according to Alta-Soft tariff data, and WITS shows 3 to 5 percent across HS 300490 lines in 2021. Medicines are listed for the reduced 10 percent VAT rate, against a standard 22 percent from 2026. Confirm the rate for an unregistered batch with a customs broker.
• Keep the product name, strength, pack size and quantity identical across the protocol, conclusion, invoice and air waybill.
• Narcotic and psychotropic medicines follow separate rules with Interior Ministry permits and, for non-EAEU origin, a licence from the Ministry of Industry and Trade.