Russia Extends Medicine Import in Foreign Packaging Until 2027. What Importers Must Do Now
For the past three years, every December has brought a period of anxious anticipation for regulatory affairs departments within pharmaceutical companies. Will it be extended or not? Will they manage to sign it in time? In December 2025, history repeated itself, but with one fundamental difference. For the first time, the extension was secured not only at the level of a government decree but within the Federal Law itself. This changes the planning horizon for the entire industry.
We are talking about the «crisis» import mechanism — a special procedure that, since 2022, has allowed the import and sale in Russia of registered medicines in packaging designed for foreign markets. This mechanism was set to expire on December 31, 2025. Two documents signed at the end of last year extended its validity until December 31, 2027.
How It Worked Before
The baseline rules have been in place since April 2022. Decree of the Government of the Russian Federation No. 593 dated April 5, 2022 (hereinafter — Decree No. 593) established a special procedure for the circulation of medicines under sanctions pressure. Among other provisions, the document authorized the import of registered drugs in packaging intended for foreign markets, provided that a self-adhesive label containing information in Russian is placed on the consumer packaging.
This was a response to a specific problem: some foreign manufacturers stopped localizing their packaging or withdrew from the Russian market entirely. To prevent these medicines from disappearing from pharmacy shelves, the government permitted temporary trade in the exact form they were manufactured for other countries.
The mechanism was initially conceived as a short-term measure. In practice, it was extended annually: in 2023 until the end of 2024, and in December 2024 via Government Decree No. 1964 (hereinafter — Decree No. 1964) until the end of 2025.
Throughout this period, two conditions remained unchanged: the medicine had to be officially recognized as facing a shortage by the Interagency Commission (IAC) under the Ministry of Health, and every package had to bear a sticker in Russian.
What Changed at the End of 2025
In December 2025, two regulatory documents were published that finally resolved the annual question of extensions.
Federal Law No. 483-FZ dated December 15, 2025 amended Article 47 of Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicines.» Prior to this point, the permission to import in foreign packaging existed solely at the sublegislative level via government decrees. Now, this provision is codified directly into federal law, with a clear horizon up to December 31, 2027.
Decree of the Government of the Russian Federation No. 2219 dated December 30, 2025 (hereinafter — Decree No. 2219) aligned Decree No. 593 with the new law: in paragraph 34(1), the words «Until December 31, 2025» were replaced with «Until December 31, 2027.» This decree entered into force on January 1, 2026.
| Parameter | Before (Until Dec 31, 2025) | Now (From Jan 1, 2026) |
|---|---|---|
| Validity of the mechanism | Until December 31, 2025 | Until December 31, 2027 |
| Legal level | Government Decree | Federal Law + Government Decree |
| IAC approvals issued before 2025 | Valid until December 31, 2025 | Require replacement upon application to the Ministry of Health |
| Annual renewal of permits | Required | Not required until the end of 2027 |
Previously, companies found themselves in a state of uncertainty every November and December: would an extension happen, and when exactly? Now the industry has a two-year planning horizon, and the mechanism itself has been elevated to legislative status. For long-term contract supply chains, this is a meaningful difference.
What Remained the Same
The extension of the deadline has not relaxed the operational requirements governing the import process.
Approval from the Interagency Commission
Importation is still limited to medicines officially recognized as facing a shortage. The Interagency Commission (IAC) under the Ministry of Health determines the list of such drugs and issues the corresponding approval. Without it, the provisions of Section IV of Decree No. 593 cannot be applied. The registry of issued approvals is published on the official website of the Ministry of Health.
According to Decree No. 1964, approvals issued prior to January 1, 2025 remained valid only until December 31, 2025, and are subject to replacement based on an application from the legal entity. Companies that did not re-register their documents during 2025 must check the status of their approvals and update them to cover the period up to 2027.
The Russian-Language Sticker
Every unit of consumer packaging must carry a self-adhesive label featuring required information in Russian. Pursuant to paragraph 34(1) of Decree No. 593, this is a mandatory condition for market access, not optional.
What must be included on the sticker: International Nonproprietary Name (INN), trade name, dosage, pharmaceutical form, batch number, expiration date, storage conditions, and the Marketing Authorization (MA) holder.
Track-and-Trace Marking in the MDLP System
Importing in foreign packaging does not exempt companies from the requirements of the track-and-trace system (MDLP / «Chestny ZNAK»). The Data Matrix code must be applied at a customs warehouse before the goods are released into free circulation: after the goods are placed under the customs warehousing procedure (IM 70) and prior to filing the declaration for domestic consumption (IM 40). The data on the sticker and the records in MDLP must match exactly.
What Are the Risks of Errors?
Market participants frequently misinterpret «crisis» imports as a relaxed regime. While it is true that packaging requirements are simplified, the regulator’s stance on liability remains entirely unyielding.
Article 6.33 of the Code of Administrative Offenses of the Russian Federation applies if a medicine is imported in foreign packaging but the IAC has not issued a shortage approval, or if the validity period of that approval has already expired. In such cases, the product is legally classified as an unregistered medicine. The administrative fine for legal entities ranges from 1 to 5 million rubles, and may also result in the administrative suspension of business operations.
Article 14.43 of the Code of Administrative Offenses applies for non-compliance with sticker requirements — an incorrect expiration date, missing storage conditions, or a typo in the batch number. Courts consistently reject arguments attempting to dismiss these infractions as minor. «Posing a threat to the life and health of patients» is standard language in these judicial rulings.
The extension also introduces an additional risk. An IAC approval can be revoked at any time if the shortage is resolved. If a Russian-made alternative enters the market and the commission cancels its approval, further importation under the crisis scheme becomes illegal. The Ministry of Health’s registry of approvals should therefore be reviewed at least once a quarter.
What to Do Next
Audit the status of your IAC approvals across your entire portfolio. Approvals issued before January 1, 2025 expired on December 31, 2025, and require replacement. Consult the official registry on the Ministry of Health website to verify that a valid approval is in place for each product. Where documentation has lapsed, file applications for replacement.
Update contracts with customs warehouses. Agreements must clearly define who bears liability for stickering and applying MDLP serialization codes — the importer or the warehouse operator. Vague wording frequently becomes a source of disputes during Roszdravnadzor inspections.
Conduct a sticker audit. Cross-check the sticker layout approved during the IAC procedure against what is actually being affixed to the physical packaging. Verify all mandatory fields: INN, trade name, dosage, formulation, batch number, expiration date, storage conditions, and MA holder.
Establish routine monitoring of the approvals registry. Set up a regular compliance workflow to review the Ministry of Health registry at least once per quarter. If the commission revokes an approval for your product, you will need lead time to halt incoming shipments before a violation occurs.
Verify the MDLP data chain. Ensure that the data printed on the sticker matches the data submitted to the track-and-trace system exactly, down to the batch number and expiration date. A discrepancy of even a single character will block the product from entering commercial circulation.
The two-year planning horizon and direct entrenchment in federal law give the pharmaceutical industry a level of stability it has lacked since 2022. Companies that use this period to refine their document management and compliance processes will face the next regulatory deadline with systems already in place.
Regulatory Framework:
1. Decree of the Government of the Russian Federation No. 2219 dated December 30, 2025, «On Amending Decree of the Government of the Russian Federation No. 593 dated April 5, 2022.»
2. Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicines» (as amended December 29, 2025), Article 47.
3. Federal Law No. 483-FZ dated December 15, 2025, «On Amending Article 47 of the Federal Law ‘On the Circulation of Medicines’.»
4. Decree of the Government of the Russian Federation No. 593 dated April 5, 2022, «On the Specifics of the Circulation of Medicines for Medical Use in the Event of a Shortage or Risk of Shortage of Medicines in Connection with the Introduction of Economic Restrictions Against the Russian Federation» (as amended December 30, 2025).
5. Decree of the Government of the Russian Federation No. 1964 dated December 28, 2024, «On Amending Decree of the Government of the Russian Federation No. 593 dated April 5, 2022.»