Importing Medicines into Russia and the CIS: A Country-by-Country Guide (2026)

Last updated: 27 September 2026. Part of our region-by-region import guide series. Covers Russia and every other former Soviet market outside the EU.

Russia and the CIS aren't one market any more. They're three groups heading in different directions. The Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia) is moving to one shared registration system, and it rewards local production more every year. Uzbekistan and the rest of Central Asia are opening up fast, with recognition routes and generous incentives for partners who build locally. Ukraine and Moldova are rewriting their rules on EU lines. Almost everywhere, you need a local representative, labels in the local language, a digital marking code and a clear plan for getting paid.

This guide walks through every market in plain language:

• The Eurasian Economic Union (EAEU): Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia, plus the shared EAEU registration rules.
• Central Asia outside the EAEU: Uzbekistan, Tajikistan and Turkmenistan.
• The South Caucasus: Georgia and Azerbaijan (and Armenia, above).
• Eastern Europe: Ukraine and Moldova.

Armenia and Azerbaijan are also covered in our Middle East and North Africa guide. Estonia, Latvia and Lithuania follow EU rules and will be covered in our European guide. This one is written for manufacturers exporting from India, China, Korea, Europe and the US, and for the regional distributors and importers who work with them.

How the region works

The same three doors exist here as everywhere else: register and sell commercially, supply public tenders, or use a special import route for an unregistered medicine a patient needs. A few things shape all of them:

• Two rulebooks in the EAEU. The shared EAEU rules are the future, but member states can keep registering products under national rules until 31 December 2027. For now you can choose, and the choice matters.
• Your plant will be inspected. EAEU members, Uzbekistan and Ukraine all want their own GMP evidence, not just your home regulator's certificate.
• Every pack needs a code. Russia, Kazakhstan, Uzbekistan and Kyrgyzstan run national marking systems, and they don't accept each other's codes.
• Language on the pack. Russian is widely required, often alongside Kazakh, Uzbek, Tajik or Turkmen. Ukraine, Moldova and Georgia use their own languages.
• Localisation is built into the rules. Russia scores products on how much is made locally, Kazakhstan gives local plants 10-year state contracts, and Uzbekistan wants 70% of its market made at home by 2030.
• Getting paid takes planning. Medicines are generally allowed under Western sanctions on Russia and Belarus, but banks, shipping and currency controls make payment the hardest part of many deals.

The biggest markets at a glance

The EAEU: one union, two rulebooks

The five EAEU members share a common market for medicines, built on a set of 2016 decisions: Decision 78 for registration, 77 for GMP, 83 for inspections, 76 for labelling and 87 for pharmacovigilance. All of them have been amended several times since.

• How EAEU registration works. You pick a reference state, which assesses the full dossier, and name the recognition states you want. Under the decentralised procedure, the reference state has up to 140 working days and each recognition state up to 50 more.
• Who holds the registration. The rules don't require the holder to be based in the EAEU, but your qualified person for pharmacovigilance must live and work in a member state, and countries can ask for a local contact too. In practice, most foreign companies work through a local office or representative.
• GMP inspection. A member state's inspectorate inspects foreign plants; in Russia that's the State Institute of Drugs and Good Practices. Since June 2025, the inspection can happen during registration or within three years after it, on a risk basis.
• The 2025 deadline. Products registered nationally had to be filed for conversion to EAEU rules by 31 December 2025. Products filed in time keep their national certificates for up to three years in the reference state, plus up to two more in recognition states.
• National rules still run to 2027. In May 2025 the EEC extended its temporary measures to 31 December 2027, so member states can still register new products and changes under national procedures until then. Kazakhstan has said it's using this to avoid shortages.
• Marking isn't shared. Each member runs its own system, so plan separate codes for Russia, Kazakhstan and Kyrgyzstan.

Russia

• Registration: new products follow the EAEU rules. Russia also kept a national accelerated route, and certificates issued under its simplified procedures were extended to the end of 2027. For products that missed the conversion deadline, a December 2025 decree extended certificates to 1 January 2027 if they'd been on the market for at least three years.
• Pricing: for products on the Vital and Essential Drugs List, the maximum ex-factory price is registered with the state. Since September 2025, a foreign product's price can't be above the manufacturer's lowest price across 11 reference countries (Belgium, Hungary, Greece, Spain, the Netherlands, Poland, Romania, Slovakia, Turkey, France and the Czech Republic) or its home country.
• Tenders: public buying runs under Federal Law 44-FZ, with a "national regime" that favours EAEU-made products. From 1 July 2026, for 206 strategically important medicines, bids with full-cycle EAEU production, including the API, beat bids with partial localisation.
• What counts as local: since January 2026 a product needs at least 50 points to count as Russian-made. Making the finished product in the EAEU earns 50 points, and making the API, or for biologicals the cell bank, fermentation and purification, earns more.
• Marking: every pack has been marked in the national system (Chestny ZNAK / MDLP) since July 2020, and codes are checked online at sale.
• Without registration: the Ministry of Health issues import permits for unregistered medicines for named patients, based on a medical commission's decision. Separately, registered medicines in foreign packaging can be sold during shortages with a Russian sticker and leaflet, a route extended to the end of 2027.
• Payments: US rules include a general licence for medicine transactions with Russia, but banks still screen every deal. Russia–India trade is now mostly settled in roubles and rupees.
• Market: about 3.3 trillion roubles in 2025. Russian-made products held 46.8% by value and 69.3% by packs, and 87.3% of packs in hospital purchases.

Belarus

• Registration: RCETH (the Center for Examinations and Tests in Health Service) handles the technical work. Since May 2026, strategically important medicines can use a simplified route if they're already approved elsewhere in the EAEU, and conditional registration is easier.
• Without registration: RCETH issues permits to import unregistered medicines for named patients, clinical trials and exhibitions.
• Tenders: centralised buying is organised by Belfarmatsiya, Belmedtekhnika and the regional "Farmatsiya" enterprises, under yearly Ministry of Health orders.
• Watch out for: the same sanctions and banking checks as Russia.

Kazakhstan

• Regulator: the National Center for Expertise of Medicines and Medical Devices. In April 2026, Kazakhstan became the first Central Asian country to reach WHO maturity level 3.
• Registration: the EAEU route or, until the end of 2027, national procedures. A trade portal reported that about two-thirds of the roughly 6,900 registered medicines already meet EAEU standards.
• Pricing: an imported product's price can't exceed the highest of the three lowest reference-country prices. Rules from January 2025 cut retail markups, added Kyrgyzstan and Uzbekistan to the basket, and set generics at 30% below the originator and biosimilars at 10% below. VAT on medicines was reported to start at 5% in 2026.
• Tenders: SK-Pharmacy is the single distributor for the state-guaranteed package and compulsory health insurance. Local manufacturers can win 10-year offtake contracts, and 89 are in place with 35 producers. One route covers local contract manufacturing of patented originals.
• Without registration: unregistered medicines can be imported for a specific patient's vital needs or for groups of patients with rare diseases.
• Marking: every medicine has needed a Kazakh Data Matrix code since July 2024, issued by Kazakhtelecom. Foreign codes aren't accepted.

Kyrgyzstan

• The Ministry of Health's medicines department registers products, and national procedures are available until the end of 2027. The conversion to EAEU standards has been slow, with only a small share of national registrations converted by early 2025. The government has simplified temporary imports of unregistered essential medicines in emergencies or when a product hasn't been imported for six months. Tenders run through the national e-procurement portal.

Armenia

• Armenia runs both national and EAEU registration, with a simplified national route for products approved in the EU, US or Japan or prequalified by WHO. 2026 amendments allow unregistered essential and cancer medicines to be imported. See our MENA guide for more detail.

Central Asia outside the EAEU

Uzbekistan

• Regulator: the Center for Pharmaceutical Products Safety registers products, and the Agency for the Development of the Pharmaceutical Industry drives industrial policy.
• Recognition route: since October 2025, products approved by a WHO-Listed Authority or a WHO maturity level 4 regulator can be registered by recognition without full re-testing. That covers the EMA and EU regulators, the US FDA, Health Canada, Japan's PMDA, the UK's MHRA and Korea's MFDS. India and China approvals don't qualify under the current WHO lists.
• Standard route: new rules from February 2026 set a 210-day review for medicines and five-year certificates. Dossiers follow a modified CTD, and labels and leaflets are in Uzbek and Russian.
• GMP: from January 2026, foreign and local manufacturers need a national Uzbek GMP certificate to register or renew. It becomes mandatory for all medicines from January 2027. WHO-prequalified products on the recognition route are exempt.
• Pricing: prescription medicines have reference prices, updated automatically when exchange rates move. OTC products were deregulated.
• Tenders: since 2025, original medicines can be bought directly from the manufacturer or its official distributor, and state buying is moving to a central Ministry of Health procurement centre.
• Localisation: the target is 70% domestic production by 2030. Incentives include a 5% tax on royalties, 50% reimbursement of tech transfer costs, support for EU GMP certification and full reimbursement of FDA or EMA registration costs for local manufacturers.

Tajikistan

• The Ministry of Health registers products, with expert review by its state supervision service. Consultants report a national dossier format (CTD accepted), a GMP certificate, three to six months to register, five-year certificates and labels in Tajik and/or Russian. The market is mostly imported.

Turkmenistan

• The Center for Registration of Medical Products and State Quality Control in Ashgabat registers products. Consultants report a 180-day review with lab testing, a required local representative and labels in Turkmen, Russian and/or English. The Ministry of Health has bought medicines for chronic diseases through UNDP. It's a closed market, so work through an experienced local partner.

The South Caucasus

Georgia

• Recognition registration: products authorised by regulators on a government list, which consultants say includes the EU, Switzerland, the UK, the US, Canada, Japan, Australia and Korea, are entered in the registry in seven working days with a GMP certificate. National registration takes up to three months.
• Pricing: reference pricing, introduced in 2022–23, now caps prices on more than 7,500 medicines, with about 700 more being added in 2026.
• Watch out for: wholesale of psychotropic and controlled medicines was moved to a state centre in October 2025, and Georgia's EU accession process has stalled.

Azerbaijan

• The Analytical Expertise Center registers products, with a route based on recognising foreign registrations and a notarised Azerbaijani leaflet. TABIB supplies insured patients, and medicines packaged in Azerbaijan count as local goods in public procurement. See our MENA guide for more.

Ukraine and Moldova: heading for EU rules

Ukraine

• Registration today: the Ministry of Health registers products after assessment by the State Expert Center, and GMP is confirmed by the State Service on Medicines and Drugs Control, a PIC/S member since 2011. A simplified route covers products approved by the EMA or in the US, Switzerland, Japan, Australia or Canada. The standard route needs a full eCTD dossier.
• Big change in 2027: the new Law on Medicinal Products applies from 1 January 2027, and a new EU-style regulator, the Ukrainian Pharmaceutical Agency, takes over the same day. Most simplified procedures end, and existing products get five years to align their dossiers, including moving to an EU-style SmPC and leaflet.
• Pricing: since 2025, products must be listed in a National Price Catalogue. The maximum wholesale price is based on prices in Bulgaria, Czechia, Hungary, Latvia, Moldova, Poland, Romania and Slovakia, generics and biosimilars are capped at 75% of the originator, and markups are capped. In 2025 the government also cut prices on 100 popular medicines by 30%.
• Tenders: Medical Procurement of Ukraine is the central buyer, with UNICEF, UNDP and Crown Agents also buying on its behalf, and tenders open on ProZorro. The 2026 budget has UAH 15.2 billion for central procurement and UAH 8.7 billion for the Affordable Medicines reimbursement programme.
• Without registration: wartime rules introduced in 2022 allow unregistered medicines for the armed forces and hospitals. Check whether they still apply to your case.

Moldova

• Registration: a new medicines law aligned with EU rules came into force in July 2025, and the regulator, AMDM, authorised 245 medicines in the first seven months of 2026. Draft rules from April 2026 propose a 10-working-day route for EU-approved products, a 45-day route for WHO-prequalified products and a 210-day general route.
• Pricing: manufacturer prices must be approved and listed in a national catalogue, benchmarked against reference countries, before an import permit is issued.
• Tenders: CAPCS, the Centre for Centralised Public Procurement in Health, publishes tenders on its website.
• Watch out for: fast EU alignment, including serialisation and supply-interruption notices, as accession talks move forward.

Localisation isn't only a barrier: bulk, API, tech transfer and partnerships

In this region, the rules themselves tell you where the business is going. Russia rewards products whose API is made in the EAEU. Kazakhstan gives local plants 10-year state contracts. Uzbekistan pays half the cost of tech transfer. For finished-dose exporters, that means shrinking tender access. In our experience of business development in the region, it also means local companies are actively looking for partners:

• Ready-to-fill bulk. Local plants often start by filling and packing imported bulk, then move further back up the chain.
• APIs. Russia's points system and full-cycle rules make API supply and local API production valuable. In June 2026, Russia's BratskChemSynthesis and China's Zhejiang Henkan agreed a joint venture to make APIs in Bratsk. See our guide to CEP vs DMF vs ASMF.
• Tech transfer and contract manufacturing. Kazakhstan's offtake contracts include local contract manufacturing of patented originals; AstraZeneca has used this route with SK-Pharmacy.
• Licensing and royalties. Uzbekistan taxes royalties for technology and trademark transfers at only 5% until 2030, which makes licence deals more attractive. Our guide to out-licensing a dossier explains how they're priced.
• Joint ventures. In January 2026, Kazakhstan announced four new plants to localise 356 medicines, with partners including China's Sinopharm, Sinovac and Kangtai and Turkey's Nobel İlaç and Abdi İbrahim.

The opportunity is strongest in oncology, hormones, biosimilars and other complex products. Russian reports point to Indian companies moving from generics into localised oncology and hormonal production, and Uzbekistan's Tashkent Pharma Park counts Turkish, Korean and Ukrainian companies among its partners.

If you're a manufacturer, ask your distributors in the region whether they're planning local production; the partner who supplies bulk today is often first in line for the tech transfer tomorrow. And if you're a regional company building local capability, post an RFQ and choose dossier licensing as the registration need, and we'll help you find manufacturers open to bulk supply, tech transfer or licensing.

What this means for exporters from India, China, Korea, Europe and the US

For every exporter

• Decide your EAEU route early. National procedures are open until the end of 2027, but everything ends up under EAEU rules. Choose your reference state carefully; it does the full review and its inspectors may visit your plant.
• Budget for marking. Separate marking systems in Russia, Kazakhstan, Uzbekistan and Kyrgyzstan mean separate codes, packaging lines and IT work.
• Plan the payment route before you quote. Agree currency, bank and shipping route up front, and check sanctions rules for Russia and Belarus.
• Watch the 2027 cut-offs. Ukraine's new law, the end of EAEU national procedures and Uzbekistan's mandatory GMP certificate all land in 2027.
• Offer more than finished doses. Where localisation rules win tenders, bulk, APIs, tech transfer and licensing keep you in the market.

Exporting from India

• Russia is still a big opportunity. Indian sponsors ran almost half of the foreign-sponsored clinical trials in Russia in 2025, and trade is now largely settled in roubles and rupees. But Russia's localisation rules mean long-term growth increasingly comes through local production.
• Expect inspections. EAEU and Uzbek GMP inspections are the main hurdle for Indian plants, so prepare your sites before filing.
• Uzbekistan's recognition route won't help most Indian-only approvals. It relies on WHO-listed authorities. A product with FDA, EMA or MHRA approval can use it; one approved only in India goes through the standard route.

Exporting from China

• APIs and joint ventures are the way in. The Bratsk API joint venture in Russia and the Sinopharm, Sinovac and Kangtai projects in Kazakhstan show how Chinese companies are building local presence.
• Expect standard review. China's NMPA isn't a WHO-listed authority, so Chinese-only approvals don't qualify for Uzbekistan's recognition route or Georgia's.

Exporting from Korea

• Your approvals travel further here. Korea's MFDS is a WHO-listed authority, so MFDS approvals can use Uzbekistan's recognition route, and consultants report Georgia recognises them too.
• Uzbekistan is a natural partner. Korea Eximbank financed Tashkent Pharma Park, and Korean companies are already among its partners.

Exporting from Europe

• EMA approval is a strong ticket in the west and south. It opens Ukraine's simplified route, Georgia's recognition registration, Uzbekistan's recognition route and, once finalised, Moldova's 10-day route.
• Your European prices travel east. Russia caps Essential Drugs List prices at the lowest price in 11 reference countries, 10 of them in the EU. Ukraine and Moldova also benchmark against EU prices.
• Check EU sanctions for Russia and Belarus. Medicines are generally allowed, but screen partners, banks and routes for every deal.

Exporting from the US

• FDA approval opens recognition routes in Uzbekistan, Georgia and Ukraine.
• Russia is possible but needs care. A US general licence authorises medicine transactions with Russia, but screen every counterparty and bank, and expect your own bank to ask detailed questions.

Quick answers

Do I need to register in every EAEU country?

Not separately. Under EAEU rules, one reference state reviews your dossier and the other member states you choose recognise it. Until the end of 2027, national registration in individual countries is also still possible.

Can a foreign company hold a marketing authorisation in Russia?

Yes. EAEU rules don't require the holder to be based in the union, but your pharmacovigilance lead must live in a member state, and in practice most foreign companies work through a local office or representative.

Which approvals speed up registration in Uzbekistan?

Approvals by WHO-Listed Authorities and WHO maturity level 4 regulators, including the EMA, US FDA, Health Canada, PMDA, MHRA and Korea's MFDS, qualify for recognition registration.

Are medicines affected by sanctions on Russia?

Medicines are generally allowed under Western sanctions, and the US has a general licence for medicine transactions. But payments, banks and logistics are still screened, so plan the payment route before you quote.

Can unregistered medicines be imported for patients?

Yes, in most countries. Russia issues named-patient import permits based on a medical commission decision, Belarus through RCETH, Kazakhstan for vital needs and rare diseases, and Armenia and Kyrgyzstan have their own routes.

Ready to source for your market?

• Importers, distributors and tender bidders in Russia, Central Asia and the CIS: post your sourcing RFQ. Our RFQ guide shows what to include.
• Hospitals and patients needing an unregistered medicine: submit an RFP for named-patient import.
• Manufacturers looking to supply the region, whether finished products, bulk, APIs or tech transfer and licensing: list your company and products so buyers and agents can find you.

This guide summarises public regulations and official sources as of September 2026. Rules change often in this region, especially around the EAEU transition, Ukraine's 2027 reform and sanctions. Confirm current requirements with the regulator or a local regulatory partner, and run sanctions checks where relevant, before acting.

Sources

• Acts on the common market for medicines (Eurasian Economic Commission)
• EEC Council Decision 78 on registration rules, as amended (ConsultantPlus)
• EEC Council Decision 34 of 22 May 2025 on transition rules (Alta)
• Changes to EAEU medicines rules from June 2025 (Eurasian Economic Commission)
• EEC Council Decision 29 of 14 May 2025 extending temporary measures to 2027 (Alta)
• EAEU extends national registration deadlines (Kazakhstanskaya Pravda, 2025)
• Decision 87: Good Pharmacovigilance Practice of the EAEU (Eurasian Economic Commission)
• Ministry of Health letter on the end of the conversion period (Garant, January 2026)
• Government Decree 2202 extending certificates to 2027 (Garant, December 2025)
• Decree 805 on registering maximum prices for essential medicines (Garant, May 2025)
• Procurement of strategically significant medicines (PPT.ru, 2026)
• Decree 1392 on localisation points for medicines (Garant, September 2025)
• Decree 2219 extending sale of medicines in foreign packaging (Garant, December 2025)
• New procedure for importing unregistered medicines (Pepeliaev Group)
• Russia-related general licences (US Treasury OFAC, June 2024)
• Russian pharmaceutical market in 2025 (Pharmprom, April 2026)
• Russia–India rupee–rouble payments (The Bridge Chronicle, September 2026)
• Russia and China to build API production in Irkutsk region (Vedomosti, June 2026)
• Indian pharma localising innovative drugs in Russia (GxP News, April 2026)
• Import of unregistered medicines (RCETH, Belarus)
• Council of Ministers Resolution 224 on registration of strategically important medicines (Belarus, May 2026)
• Centralised procurement (Ministry of Health of Belarus)
• Kazakhstan reaches WHO maturity level 3 (WHO, April 2026)
• The pharmaceutical market in Kazakhstan (Medservice, October 2025)
• Amendments to price regulation in Kazakhstan (Legal 500)
• 5% VAT on medicines in Kazakhstan (VATupdate, January 2026)
• Kazakhstan's drug procurement system (Prime Minister of Kazakhstan, November 2024)
• Long-term contracts with local producers (SK-Pharmacy)
• AstraZeneca and SK-Pharmacy long-term contract (Kazakh Invest)
• Four new pharmaceutical plants in Kazakhstan (Prime Minister of Kazakhstan, January 2026)
• Marking of medicines (Kazakhtelecom)
• EAEU conversion in Kyrgyzstan (24.kg, February 2025)
• Kyrgyzstan simplifies temporary import of unregistered medicines (24.kg)
• Center for Pharmaceutical Products Safety (Uzbekistan)
• Presidential Decree UP-137 of 19 August 2025 (Lex.uz)
• Uzbekistan's new registration rules (Gazeta.uz, August 2025)
• WHO designates new WHO-Listed Authorities (WHO, August 2025)
• New state registration rules in Uzbekistan (Legal 500, February 2026)
• Amendments to medicine price regulation in Uzbekistan (Legal 500)
• Direct medicine purchases from manufacturers (Daryo, December 2024)
• Pharmaceutical industry development (Government of Uzbekistan, March 2026)
• Tax and customs support for the pharmaceutical industry (EY, May 2026)
• Tashkent Pharma Park (Embassy of Uzbekistan in India, April 2020)
• Registration of medicines in Tajikistan (Cratia)
• Center for Registration of Medical Products (Ministry of Health of Turkmenistan)
• Registration of medicines in Turkmenistan (Cratia)
• Procurement of NCD medicines through UNDP (UNDP Turkmenistan)
• Law on Medicines and Pharmaceutical Activities (Georgia, Matsne)
• Registration of medicinal products in Georgia (MSP)
• Reference prices for 700 more medicines (Georgia Today, May 2026)
• Georgia centralises wholesale of psychotropic medicines (Georgia Today)
• EU relations with Georgia (Council of the EU)
• PIC/S participating authorities (PIC/S)
• Ukraine's new law on medicinal products (MSP, July 2026)
• Cabinet creates the Ukrainian Pharmaceutical Agency (Ukrainian News, June 2026)
• Simplified registration procedures in Ukraine (Cratia, June 2025)
• Ukraine expands price regulation of medicines (CMS, April 2025)
• Pharma market reform: first results (Cabinet of Ministers of Ukraine, July 2025)
• NSDC decision on medicine price cuts (President of Ukraine, February 2025)
• 2026 health budget (Cabinet of Ministers of Ukraine)
• Medicines procurement (Ministry of Health of Ukraine)
• Simplified medicines procedures under martial law (Cabinet of Ministers of Ukraine, April 2022)
• EU and Ukraine open first accession cluster (Council of the EU, June 2026)
• Law on Medicines published (AMDM Moldova, July 2025)
• Draft Government Decision on medicines authorisation (Government of Moldova, April 2026)
• Medicines authorised by AMDM in 2026 (Moldova 1)
• Registration of manufacturer prices (Government of Moldova)
• Tender notices (CAPCS Moldova)
• EU and Moldova open first negotiation cluster (Council of the EU, June 2026)