Russia Extends Parallel Drug Imports to 2027: How the Shortage Mechanism Under Decree No. 593 Works
A pharmacy receives a shipment of a German-made medicinal product. The packaging is covered in Turkish text, a Russian label is pasted over it, and the original manufacturer has no idea its product ended up in Russia. Three years ago, this would have meant seizure and criminal charges. Today, it is a legal pathway for hundreds of medicinal products.
What began as an anti-crisis measure in 2022 has, by January 2026, become a permanent fixture of the system.
Below, we look at how parallel import functions in pharmaceuticals, which regulatory mechanisms make it possible, and what risks the scheme carries.
From Temporary Measure to Permanent Mechanism
Economic sanctions threatened the availability of many medicines. Some foreign manufacturers halted supplies or curtailed volumes. Others stayed in the market but could not meet surging demand.
The standard parallel import mechanism, established by Federal Law No. 213-FZ of June 28, 2022, does not apply to medicines. Pharmaceutical products were excluded from Minpromtorg’s (Ministry of Industry and Trade) list (Order No. 1532). The reason is straightforward: quality, safety, and traceability risks are too high for a blanket approach.
Instead, a separate system was built for medicines. Its foundation is Government Decree No. 593 of April 5, 2022 «On the specifics of the circulation of medicinal products for medical use in the event of a shortage or risk of shortage» (hereinafter: Decree No. 593).
Formally, this is called a «special circulation procedure during shortage conditions,» but the substance is the same: importing medicinal products without the trademark holder’s consent. The mechanism was originally introduced as temporary, through the end of 2023. The deadline was then extended to end-2024, then to end-2025. On December 30, 2025, Decree No. 2219 moved the expiry date to December 31, 2027.
The two-year planning horizon stabilizes «gray» supply channels. Distributors can now sign long-term contracts with intermediaries in transit jurisdictions — Turkey, the UAE, India, China — without fearing a sudden closure of the regulatory window.
These changes rest on amendments to Article 47 of Federal Law No. 61-FZ «On the Circulation of Medicines,» codified by Federal Law No. 494-FZ of December 26, 2024. Parallel import now has statutory backing at the federal level.
How the Shortage System Works
Any market participant — manufacturer, distributor, pharmacy chain, or medical organization — can trigger the special procedure by submitting a proposal to the Ministry of Health of the Russian Federation to have a medicinal product recognized as being in shortage (defektura).
The proposal must be substantiated: it must explain why the product is unavailable or why a risk of unavailability exists. By 2026, the criteria for determining shortage have expanded considerably. Where an official manufacturer’s letter about cessation of supply was the primary indicator in 2022–2023, the commission now weighs a combination of factors.
Logistical vulnerability. The analysis covers not only the finished dosage form but the entire supply chain of APIs (active pharmaceutical ingredients) and excipients. A deficit of a specific blister polymer or pharmaceutical-grade glass vials can now trigger shortage-risk status.
Price disparity. When exchange rates are volatile, the registered ceiling manufacturer price may fall below actual import costs. Even with stock sitting in the manufacturer’s warehouses, supply becomes economically unviable.
Sanctions risks. Including a manufacturer or its beneficiaries in new sanctions packages automatically triggers a status review for the product.
Decisions are made by an inter-agency commission under the Ministry of Health, whose members include representatives from Minpromtorg, the Federal Customs Service, Roszdravnadzor, and experts from NCESMP, FTsPiLO, and TsEKKMP. The commission’s charter was approved by Ministry of Health Order No. 128n of March 17, 2025, with its mandate extended to December 31, 2027.
Between 2022 and early 2026, the commission designated over 200 medicinal products as shortage products, including oncology medicines, immunoglobulins, anesthetics, antibiotics, and hormonal preparations.
Table 1: Shortage Drug Categories and Volumes (as of early 2026)
| Drug Category | Approx. Number of Items |
|---|---|
| Oncology | 40–50 |
| Immunologicals | 20–25 |
| Anesthetics | 15–20 |
| Antibacterials | 25–30 |
| Others | 60–70 |
Once a product is designated as a shortage product, several pathways open. A previously unregistered medicinal product may be registered through the accelerated procedure under Decree No. 593. A registered product can be imported in foreign packaging with a Russian-language label applied. A batch of an unregistered product may temporarily enter circulation, or simplified amendments may be made to the registration dossier.
Specification Conflicts When Importing from Different Markets
Suppose a medicinal product is registered in Russia, but the manufacturer no longer supplies this market. An importer finds the same product in Turkey or India and wants to bring it in under the special procedure.
A problem arises immediately: specifications can differ across markets. A Turkish batch may carry different excipients, a different concentration, a different shelf life. Global pharmaceutical companies routinely use different excipient suppliers for different regional markets depending on local raw material availability.
The main divergence points:
Excipients. The composition may differ depending on the production region and the requirements of local regulators.
Primary packaging. Blister materials (PVC/PVDC versus aluminium/aluminium) vary by climate zone. Zone II for Europe and Russia differs from Zone IVb for hot climates.
Shelf life. Products destined for hot-climate markets may be assigned a shorter shelf life due to accelerated degradation.
Decree No. 593 requires the medicinal product to comply with the specifications established during its state registration in Russia — with an exception made only for packaging. This creates a regulatory paradox: the importer must demonstrate conformity with Russian regulatory documentation while holding a product manufactured to a foreign specification.
Quality Control and Remote Expertise
Resolving the contradiction between Russian requirements and foreign specifications falls to testing laboratories. By 2026, practice has coalesced around alternative quality assessment methods.
Comparative Dissolution Kinetics Testing (CDKT) has become the de facto standard for justifying biowaivers — registration without new clinical trials. The method rests on a premise: if the dissolution profile of the imported product across various pH media (1.2, 4.5, 6.8) matches the profile of the Russian reference product, the two products are assumed to behave identically in the patient’s body.
EEC Council Decision No. 85 (Rules for Conducting Bioequivalence Studies) permits this substitution for products with high solubility and permeability (BCS Classes I and III). Experts have flagged the risk of applying CDKT to shortage-list products beyond the boundaries of scientific recommendations — particularly for products with a narrow therapeutic index, where even minor deviations in bioavailability can lead to toxicity or therapeutic failure, and for modified-release forms, where matrix technologies for controlled release can differ considerably between manufacturers.
Remote quality expertise represents a more radical innovation. Under updated provisions of Decree No. 593, when standard laboratory testing is impossible — for example, because the manufacturer is blocking the supply of specific reagents, reference standards, or test strains — remote interaction is permitted. The expert institution (FSBI NCESMP of the Ministry of Health or an accredited private center) connects with the production site or the distributor’s laboratory via real-time video conference. The expert remotely observes the testing process, recording instrument readings, chromatograms, and colorimetric reactions through the camera. The video recording becomes legal evidence and is attached to the test report.
The systemic risks here are not trivial. A remote expert cannot physically verify reagent expiry dates, balance calibration, or the cleanliness of laboratory glassware. The risk of sample substitution or the use of pre-recorded data is vastly higher than with in-person presence. Remote inspection also applies to the first three batches of a product entering commercial circulation for the first time — which makes the stakes particularly high.
Applying Tracking Codes to Foreign Packaging
All medicines in Russia must be marked within the MDLP system (Drug Movement Monitoring), operated by the Chestny ZNAK (national product labeling and traceability system). Without a Data Matrix code, a medicinal product cannot be legally sold in a pharmacy or medical organization.
A product manufactured for the Turkish market carries no MDLP code. The code must be applied in Russia, at a customs warehouse or importer’s warehouse.
A consignment arrives at the warehouse in foreign transport packaging. The importer submits a code emission request through the EDO (electronic document interchange) system. A label is applied to each consumer unit bearing Russian-language information — INN (International Nonproprietary Name), trade name, dosage form, batch number, expiry date, MA holder — alongside a cryptographically protected Data Matrix code. Print standards are strict: facilities must use printers with a resolution of at least 300 dpi. Substandard print quality renders the code unreadable by pharmacy scanners.
Each unit must also be accompanied by instructions in Russian. If the instructions cannot be affixed externally (for example, because the carton is too small), the carton must be opened.
Table 2: Labeling Stages for Parallel Imports — from Entry to Pharmacy
| Stage | Action | Responsibility |
|---|---|---|
| Import | Registration at the customs post | Importer |
| Warehouse | Applying MDLP codes, inserting Russian instructions | Importer / warehouse operator |
| Verification | Checking code readability, uploading to system | Warehouse operator |
| Dispatch | Transfer of ownership within MDLP | Importer |
| Pharmacy | Confirming receipt, recording sale as dispensed | Pharmacy |
Inserting Russian-language instructions frequently requires opening the cardboard carton, which breaks the factory tamper-evident protection — whether control stickers or glued flaps. GMP — Good Manufacturing Practice — and GDP — Good Distribution Practice — rules require guaranteed packaging integrity, but the stickering procedure under parallel import de facto legalizes this breach, creating a potential window for substitution of the original blister.
The cold chain is a separate concern. For products requiring storage at +2°C to +8°C, the labeling process means moving pallets out of refrigerated units into the labeling zone, creating the risk of temperature excursions. Logistics operators must implement continuous monitoring with accurate registration logs. A single temperature check at dispatch is no longer sufficient. Equipping labeling zones with climate control units requires capital investment.
From June 1, 2026, Chestny ZNAK will cover new categories of medical devices: syringes, infusion sets, medical masks, test tubes, and condoms. This will add further load to the customs warehouse infrastructure.
Who Is Liable for Adverse Reactions Under Parallel Import
In the standard model, the Marketing Authorization (MA) holder carries responsibility for safety monitoring. The MA holder maintains a system for collecting information on adverse reactions (AR), has a designated QPPV — Qualified Person for Pharmacovigilance — and a PSMF — Pharmacovigilance System Master File. The global model depends on continuous collection of adverse reaction data from all markets to detect rare safety signals.
Parallel import breaks this model. The manufacturer did not consent to the import, does not know where its product is located, and has no intention of bearing responsibility for storage and transport conditions through a gray channel. The legal link between importer and MA holder is severed.
Under Russian law (Federal Law No. 61-FZ) and EAEU rules (EEC Council Decision No. 87; Ministry of Health Order No. 1071n), the entity importing the product into the country bears pharmacovigilance (PV) responsibility. The importer is obligated to appoint a QPPV permanently residing within the EAEU, maintain a PSMF, submit adverse reaction reports within prescribed timelines, and retain documentation for at least 15 years.
The problem is that parallel import occurs without a contract with the MA holder. The importer has no access to the manufacturer’s Global Safety Database. If a Russian patient reports an adverse reaction, the Russian QPPV records it but cannot cross-reference it with data from other countries.
The «isolated QPPV» phenomenon. A QPPV working for a parallel importer operates in informational isolation. They receive no «Dear Healthcare Professional» letters from the originator, no safety profile update notifications, and no PSURs — Periodic Safety Update Reports. The importer must produce an RMP — Risk Management Plan — in Russian, but lacking access to the originator’s confidential clinical data, the importer is forced to compile a document based solely on publicly available sources, primarily the SmPC — Summary of Product Characteristics.
Under EAEU GDP rules, a distributor acquiring a product is obligated to notify the MA holder. Under parallel import conditions, this requirement is consciously ignored: the importer conceals the purchase from the MA holder to avoid having the supply channel blocked.
The downstream consequences: if a serious adverse reaction occurs in Russia following administration of a parallel-imported product, the information reaches Roszdravnadzor. The global manufacturer may learn of the case months later — or not at all. The safety profile of the molecule in Russia begins to diverge from the global picture.
Reporting timelines for serious adverse reactions:
1. Fatal or life-threatening: 3 working days
2. Other serious reactions: 15 calendar days
Physicians and pharmacists are obligated to report adverse reactions regardless of whether the product was imported via the standard or the special procedure. Reports are submitted through the Roszdravnadzor AIS system («Pharmacovigilance 2.0»).
The Economics of Parallel Import
While the mechanism was positioned as a tool for containing prices and addressing shortages, the economic reality in 2026 is more complicated.
Logistics have grown more complex. The need for transit hubs and extended routing inevitably increases transport costs. Compliance costs — customs warehouse fees, labeling, opening and repackaging labor, Data Matrix code fees — add 5% to 15% to the per-unit cost. The result: imported products are physically available but are frequently priced above pre-crisis levels, or subject to high volatility tied to exchange rates and freight costs.
Extending Decree No. 593 to the end of 2027 sends foreign manufacturers a clear signal: the exclusive distributor model is no longer the only route to market. This may reduce incentives for foreign companies to invest in localization or maintain full-service representative offices. The economics of a costly local office, a medical affairs team, and a pharmacovigilance function are harder to justify when the same product fills the market through gray channels.
What an Importer Must Do
Companies planning to import under the special procedure must work through the following steps.
The first task is confirming shortage status. The list of shortage products is maintained in the State Register of Medicines (GRLS), under the «Journal» section for authorized users. If the required product is not listed, the importer can initiate inclusion by submitting a proposal to the inter-agency commission.
Once shortage status is confirmed, the importer must obtain a commission conclusion that importing the registered medicinal product in foreign packaging is permissible. Sessions are convened as needed, but no later than 20 days after document submission.
Labeling infrastructure comes next. The importer signs an agreement with a warehouse operator capable of applying MDLP codes — printers rated at least 300 dpi and verification scanners are required. For cold-chain products, the importer must confirm the labeling zone is equipped with climate control before any pallets are moved.
Where specifications diverge from the Russian registration dossier, the importer arranges CDKT or alternative studies to confirm conformity. Parallel to this, pharmacovigilance infrastructure must be set up: a QPPV is appointed, a local adverse reaction reporting system is established, reporting channels to Roszdravnadzor are defined, and both a PSMF and an RMP are prepared.
Finally, every consumer unit must carry a self-adhesive label with Russian-language information — trade name, INN, dosage form, strength, indications, contraindications, storage conditions, expiry date, and manufacturer name — and Russian-language instructions must be included with each pack.
Table 3: Authorized Import vs. Parallel Import — Key Parameters
| Feature | Authorized Import | Parallel Import / Decree No. 593 |
|---|---|---|
| Legal basis | MA holder consent / contract | Shortage status; no consent required |
| Packaging | Factory-printed Russian-language | Foreign packaging + warehouse sticker |
| Quality control | Full laboratory testing | Remote expertise; comparative dissolution kinetics |
| Pharmacovigilance | Integrated with global safety database | Local only; isolated from global sources |
| Labeling | Applied on the production line | Applied at customs warehouse |
| Pack integrity | Guaranteed by the factory | Often broken to insert instructions |
| Instructions | Inserted at factory, inside carton | Affixed externally or inserted at warehouse |
| Duration | Indefinite (within MA term) | Until December 31, 2027 |
Risks and Limitations
The special shortage procedure is not a universal solution. Where specifications differ substantially between markets, achieving conformity with Russian requirements may be impossible. For biological medicines and products with a narrow therapeutic index, equivalence requirements are especially stringent.
If product quality complaints arise, the manufacturer is entitled to state that it had no control over storage and transport conditions through a gray channel. Proving a causal link between a product defect and the manufacturer’s actions becomes difficult.
Importers bear liability for harm to patients’ life and health but lack the instruments needed to prevent that harm. The absence of access to global safety data creates a systemic risk.
The mechanism’s duration is fixed. The special procedure was introduced as a temporary measure. From 2028, it may be repealed or materially curtailed. The compliance costs — relabeling, comparative testing, pharmacovigilance infrastructure — require investment. For small batches, the economics may not work out. The markup runs from 5% to 15% per unit.
Sources: Federal Law No. 61-FZ «On the Circulation of Medicines» (as amended by Federal Law No. 494-FZ of December 26, 2024); Government Decree No. 593 of April 5, 2022 (as amended by Decree No. 1964 of December 28, 2024, and Decree No. 2219 of December 30, 2025); Ministry of Health of the Russian Federation Order No. 128n of March 17, 2025; EEC Council Decision No. 85 of November 3, 2016 (Bioequivalence Study Rules); EEC Council Decision No. 87 of November 3, 2016 (GVP — Good Vigilance Practice Rules); Government Decree No. 1556 of December 14, 2018 (MDLP system); Ministry of Health Order No. 1071n of February 27, 2023 (Pharmacovigilance Procedure).
Other articles on Regulatory Affairs →