Russia | Review of pharmaceutical regulations – July 2026

The State Duma of the Russian Federation passed a bill to tighten oversight of pharmaceutical manufacturers

The State Duma of the Russian Federation passed Bill No. 1280113-8, “On Amending the Federal Law ‘On the Circulation of Medicines’ and Certain Legislative Acts of the Russian Federation,” in its second and third readings. The bill, which aims to improve licensing controls over the production of medicines, was approved unanimously.

Key changes:

• New mechanisms for suspending and revoking manufacturing licenses, as well as EAEU GMP certificates, have been established. These measures will be applied when moderate or serious violations of good manufacturing practice are identified during inspections, posing a direct threat to the life and health of citizens. This precludes the possibility of facilities with systemic quality defects continuing to operate for extended periods under the guise of addressing deficiencies.
• The legal status of substandard drug batches has been clarified. The bill specifies the procedures for their removal from civilian circulation and subsequent destruction, thereby minimizing the risk of substandard products reaching consumers.
• The document officially permits the import into the Russian Federation of drug samples that were collected by state inspectors during overseas inspections of manufacturing facilities. This removes customs barriers to conducting laboratory testing as part of cross-border controls.

The adopted amendments are aimed at harmonizing Russian legislation on the circulation of medicinal products with the supranational requirements of the Eurasian Economic Union. As the authors of the bill note, its goal is to eliminate legal loopholes and establish a transparent system of regulatory requirements for manufacturers.

https://sozd.duma.gov.ru/bill/1280113-8#bh_histras

July 28, 2026

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The list of strategically important medications has been expanded

The Government of the Russian Federation adopted Order No. 1748-r of July 7, 2026, which approves changes to the list of strategically important medicines (SIMs).
The list has been expanded to include 149 new items. The document amends Government Order No. 942-r dated April 23, 2026.

The list was expanded following a review of proposals from relevant manufacturers. The updated registry includes essential and critical medicines (ECMs), as well as medications for the treatment of particularly dangerous infections, socially significant diseases, and conditions that pose a danger to others.

For pharmaceutical companies, SMLS status entails two key consequences:

1. Localization: The entire production cycle—from the synthesis of the active pharmaceutical ingredient to the release of the finished dosage form—must take place exclusively within the territory of the Russian Federation.
2. Access to government support: The establishment of such production facilities may be carried out with the assistance of government support measures.

In addition, medicines included on the list are given priority in government procurement. This measure is intended to prevent shortages and ensure a stable supply of essential medicines to public healthcare facilities—clinics and hospitals.

http://publication.pravo.gov.ru/document/0001202607080021

July 13, 2026

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Marketplaces in Russia Will Be Required to Verify the Legality of Medications: New Rules for the Pharmaceutical Retail Industry Have Been Published

The Government of the Russian Federation has established a regulatory framework for online sales of pharmaceuticals. Resolution No. 821, dated July 2, 2026, which establishes the procedure for verifying information in product listings on digital platforms, has been published on the legal information portal.

According to the document, marketplace operators are required to ensure automatic verification of data on medicines, medical devices, and dietary supplements against twelve state registries. The list includes the “Honest Mark” system, the FGIS MDLP (medication movement monitoring system), the GRLS of the Russian Ministry of Health, as well as the relevant unified registries of the Eurasian Economic Union.

To post a medication listing, a seller must simultaneously meet a number of strict conditions:

• The registration certificate number and registration date must exactly match the information in the State Register of Legal Entities or the EAEU Unified Register.
• The document’s status must be “active.” As stated in the text of the resolution, the following entries are permitted: “valid,” “issued in accordance with EAEU regulations,” “valid, pending confirmation of state registration,” or “valid, in foreign packaging” (for Russian registration units), or the status “valid” / “issued in accordance with EAEU regulations” in the EAEU registry.
• The seller (partner) must be registered in the medicinal product movement monitoring system as a distributor.
• The product card itself must contain information confirming compliance with packaging labeling requirements.

Medical devices will be inspected based on the Russian Federation’s state registry or the EAEU’s unified registry, while dietary supplements will be inspected based on the EAEU’s unified registry of state registration certificates for products.

The Federal Antimonopoly Service (FAS) is responsible for overseeing compliance with the new rules.

Government Decree No. 820 of July 2, 2026, stipulates that enforcement will begin on October 1, 2026. Platforms will be classified into three risk categories (high, moderate, low) based on transaction volume and the number of users, which will determine the frequency of inspections by the regulator.

Links:
http://publication.pravo.gov.ru/document/0001202607020011
http://publication.pravo.gov.ru/document/0001202607020016

July 7, 2026

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The EEC Board has updated the requirements for the electronic format of applications and documents in the registration dossier

The Eurasian Economic Commission adopted Decision No. 76 of June 29, 2026 “On Amending the Requirements for the Electronic Format of Applications and Documents in the Registration Dossier Submitted During the Registration and Review of Medicinal Products for Medical Use,” approved by Decision No. 79 of the Board of the Eurasian Economic Commission dated June 30, 2017.

The document establishes a new version of the requirements for the electronic format of applications and documents in the registration dossier for the registration and review of medicinal products for medical use within the EAEU.

Key changes:

• Required fields in the application: The fields regarding the type of procedure (including special procedures) and post-registration measures have been updated.

New required attributes have been added:

• • GMP compliance certification;
  • orphan drug designation;
  • information on patent protection;
  • clinical trial data.

• The requirements for providing information on valid registration certificates in other EAEU member states and the restrictions on their validity have been clarified to avoid duplication or inconsistencies in the supranational database.
• Dossier structure: The sections describing the characteristics of the drug itself—classification, dosage form, complete qualitative and quantitative composition, comparator drugs, storage conditions, and manufacturing sites—have been expanded in detail.
• The formats for master files (MF), applicant contact information, and business entity details have been updated.
• The structure of electronic data exchange has been completely revised. The new version includes 13 tables defining the formats of the data packages to be transmitted:

• 1. “Information on the Application for Registration of a Drug,”
  2. “Information on the Document Attached to the Application,”
  3. “Information on the Business Entity,”
  4. “Address” (basic version),
  5. “Contact Information,”
  6. “Information on the Master File,”
  7. “Information on the Registration of the Reference Drug,”
  8. “Information on Storage Conditions for the Drug,”
  9. “Information on an Ingredient in the Drug,”
  10. “Information on the Manufacturing Site Involved in the Production of the Drug,”
  11. “Address (Extended Version),”
  12. “Quantity per Package of the Medicinal Product,”
  13. “Information on the Registration File or Registration Dossier for the Medicinal Product.”

Effective date of the document: July 31, 2026

Link: https://docs.eaeunion.org/documents/463/10764/

July 3, 2026

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Information exchange standards within the EAEU’s unified registry of registered medicines have been revised

Decision No. 77 of the Board of the Eurasian Economic Commission, dated June 29, 2026, updated the technical standards for information exchange within the framework of the EAEU’s unified registry of registered medicinal products (amending Decision No. 122 of the EAEU Board, dated October 25, 2016).

Key changes:

• Obsolete entries have been removed from the classifiers. New reference guides have been introduced to standardize data on the reasons for suspending registration certificates (RCs) and the conditions for their revocation.
• The Regulations on Information Exchange between the Authorized Bodies of EAEU Member States and the Eurasian Economic Commission have been revised. Requirements for filling out the attribute fields of electronic documents when submitting information on the results of application reviews, creating a unified database, and making changes to it have been specified in greater detail.
• The functional roles of process participants—“Registrar” and “Approving Officer”—have been updated, which requires a review of job descriptions and access rights in national information systems.

When submitting applications for amendments or initial registration, holders of registration certificates will need to use the updated codes for reasons for suspension and grounds for revocation of the certificate to avoid formal rejections by regulators.

These changes should be taken into account when preparing supporting documentation and challenging decisions to reject applications on technical grounds.

Link: https://docs.eaeunion.org/en/documents/463/10765/

July 1, 2026