How to Import a Specific Batch of Medicines into Russia Without a Marketing Authorisation
A company is entering the Russian market with a new drug. Registration is still a year away, but samples are already needed: the NCESMP (National Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of Russia) is waiting for a batch to conduct quality evaluation. Or consider another scenario: a patient with a rare disease, where the only suitable drug is not registered in Russia, and the family has only a few weeks left. In both cases, one instrument is required: a permit to import a specific batch of a medicinal product (MP).
This mechanism has been in place since the adoption of Federal Law No. 61-FZ «On the Circulation of Medicines» dated April 12, 2010 (hereinafter — FZ-61), but the rules for its application have changed several times. In June 2025, Decree of the Government of the Russian Federation No. 913 dated June 18, 2025 expanded the list of permitted import purposes and clarified document requirements. Let us walk through how the procedure works today.
Five Cases When a Permit Is Required and Who Is Authorized to Obtain It
The core logic of FZ-61 is straightforward: only registered drugs can be sold in Russia. For everything else, an exceptional regime exists — importing a specific batch on the basis of a permit issued by the authorized body (Article 47, Part 3 of FZ-61).
Since September 1, 2024 (following Federal Law No. 1-FZ dated January 30, 2024), this regime covers five purposes. The first two cases — clinical trials (CT) and evaluation for registration — have existed for a long time. The third was added recently: the development of medicinal products and scientific research. This means that manufacturers’ R&D divisions can now import samples for their own scientific needs without being tied to a specific registration dossier. The fourth case: medical assistance based on life-saving indications for a specific patient, pursuant to a decision by a medical council (consilium). The fifth: assisting patients with severe orphan diseases through the activities of the Circle of Kindness (Krug Dobra) Foundation.
The applicant can only be a legal entity, the list of which is defined in Article 48 of FZ-61 and paragraph 5 of Decree of the Government of the Russian Federation No. 853 dated June 1, 2021 «On Approval of the Rules for Importing Medicinal Products for Medical Use into the Russian Federation» (as amended on June 18, 2025, hereinafter — Decree No. 853). A patient or their relatives cannot submit an application. Even when importing to save the life of a specific individual, the procedure is initiated by a medical organization or an authorized foundation.
Two Stages, One Chain
The procedure is sequential. First, the Ministry of Health (Minzdrav) issues a permit, then the Ministry of Industry and Trade (Minpromtorg) issues an import license. Without the first, the second cannot be obtained; and without the second, the cargo will not clear customs.
| Stage | Authority | Regulation | Timeline | Result |
|---|---|---|---|---|
| 1 | Ministry of Health of Russia | Order No. 880n dated 25.08.2021 | 5 working days | Permit (electronic) |
| 2 | Ministry of Industry and Trade of Russia | Order No. 3109 dated 11.07.2024 | 15 working days | Import license |
Both departments operate exclusively in electronic format. The Ministry of Health accepts documents via the Unified Portal of State and Municipal Services (EPGU), while the Ministry of Industry and Trade accepts them through the «Foreign Trade Information» system. Paper applications are not accepted.
What to Submit to the Ministry of Health and Where Applicants Most Often Go Wrong
The Administrative Regulation approved by Order of the Ministry of Health of Russia No. 880n dated August 25, 2021 (hereinafter — Order No. 880n) provides for four distinct document packages depending on the purpose of import.
For Clinical Trials
An application in the prescribed form must indicate the title of the trial, protocol number, Clinical Trial Authorisation (CTA) details, and the exact number of packs. The Ministry of Health cross-checks this quantity against the clinical trial materials; importing with a buffer is not allowed. The application must be accompanied by Certificates of Analysis (CoA) or Batch Release Certificates with a Russian translation, mock-ups and photographs of the packaging bearing the label «For clinical trials only,» and a copy of the foreign trade contract between the sponsor and the importer.
A common mistake: forgetting about the comparator drug or placebo. If they are not registered in Russia or are imported in clinical trial packaging, they also require a separate permit.
For Evaluation and Registration
The basis for submission is the Ministry of Health’s decision to conduct quality evaluation, the number of which must be indicated in the application. The batch volume is strictly limited to the needs of the testing laboratory: usually 50–200 packs plus active pharmaceutical ingredient (API) reference standards. Requesting more than needed will lead the Ministry of Health to treat the application as an attempt at covert commercial import.
For Drug Development and Scientific Research
Following Decree of the Government of the Russian Federation No. 913 dated June 18, 2025 «On Amending Decree No. 853» (hereinafter — Decree No. 913), the volume of the imported batch must be justified by a plan (protocol or program) of preclinical studies. For clinical trial batches, a dosing schedule is required; for registration evaluation batches, a calculation of the laboratory’s needs is required. Without such a plan, the Ministry of Health has the right to refuse.
Decree No. 913 also broadened the circle of eligible applicants: the previous wording referred to «scientific research organizations,» whereas the updated text simply states «scientific organizations.» Fundamental science institutes that did not hold the narrow status of a dedicated research organization have now gained access to this track.
For Import Based on Life-Saving Indications
This track places the highest demands on documentation. Since the application contains the patient’s personal data, it must be accompanied by:
a conclusion from a medical council (consilium) of a federal institution justifying the impossibility of using a registered alternative;
a copy of the patient’s passport (for minors — a birth certificate; for foreign nationals — a notarized translation);
written consent from the patient or their legal representative for the processing of personal data and the use of the unregistered drug.
Without consent for the processing of personal data, the Ministry of Health has no legal right to review the application, as required by Federal Law No. 152-FZ dated July 27, 2006 «On Personal Data.» The application must specify the exact number of packs for the course of treatment (usually 3, 6, or 12 months). Permits are not issued «just in case,» and a new application must be submitted for each subsequent course.
Common Requirements for All Tracks
All documents in a foreign language must be accompanied by a Russian translation. For technical documents (certificates of analysis, invoices), a translation certified by a notary or a translation bureau is sufficient. For official government documents from countries without legal assistance treaties with Russia, an apostille may be required.
All scans uploaded via EPGU must be signed by the applicant using an Enhanced Qualified Electronic Signature (EQES), which gives them the legal force of originals.
The permit is issued within 5 working days from the date of application registration; no fee is charged (Part 3, Article 47 of FZ-61). Importantly, Regulation No. 880n provides no grounds for suspending the review. Any mistake means a rejection, after which the applicant must reapply from scratch.
Ministry of Industry and Trade License
After obtaining the Ministry of Health permit, the second stage begins: import licensing pursuant to Order of the Ministry of Industry and Trade of Russia No. 3109 dated July 11, 2024 (entered into force on November 17, 2024).
The package includes an application in the EAEU form (strictly following official directories — country codes, units of measurement, and the TN VED commodity code must be taken from current classifiers), a copy of the foreign trade contract with all appendices, and the details (number and date) of the Ministry of Health permit. A copy of the permit itself does not need to be attached: the Ministry of Industry and Trade requests confirmation directly from the Ministry of Health via the System of Interagency Electronic Interaction (SMEV).
The state fee is RUB 7,500 (subparagraph 92, paragraph 1, Article 333.33 of the Tax Code of the Russian Federation). If submitted via the Gosuslugi portal, no fee is charged. If paying separately, attach the payment confirmation immediately and ensure the correct Budget Classification Code (BCC) is indicated.
The license is issued within 15 working days. Under the automatic licensing procedure, when data matches the Ministry of Health register via SMEV, the actual timeline is reduced to 5–7 days.
The key rule: information in both packages must match verbatim. If the Ministry of Health permit specifies TN VED code 3004 90 000 2 and the applicant writes 3004 90 000 1 in the Minpromtorg application, the system will issue a rejection. Different spellings of the same company name («Roche Diagnostics» vs «F. Hoffmann-La Roche») are also sufficient grounds for refusal. Verify the manufacturer’s exact legal name with your foreign partner well before the first submission.
Action Plan
Determine the purpose of import before gathering documents. The entire package depends on it. Clinical trials, evaluation, R&D, and life-saving indications each have a distinct set of requirements with different volume justifications. Mixing up the tracks is easy, and the rejection is immediate.
Double-check the completeness of the package before submission. The Ministry of Health does not suspend the review for an incomplete package — it rejects the application, and the processing timeline starts over. Go through the checklist (table below) before clicking «submit.»
Verify all details verbatim. The manufacturer’s name in the certificate of analysis, the Ministry of Health application, and the Ministry of Industry and Trade application must be identical. Clarify the exact legal name with your foreign partner before filing.
Calculate the batch volume correctly. For CT, use the dosing schedule from the protocol; for evaluation, use the declared requirements of the laboratory; for R&D, use the research plan; for individual patients, use the prescribed course of treatment. Overestimating the volume without proper justification leads to rejection.
Start the second stage immediately after receiving the permit. The Ministry of Health permit has a limited validity period, so do not delay submission to the Ministry of Industry and Trade. Accounting for 15 working days for the license plus customs clearance time, the entire process from first application to receipt of goods takes approximately 4–5 weeks with no errors.
Document Checklist for Submission to the Ministry of Health
| Document | CT | Evaluation | R&D | Life-Saving Indications |
|---|---|---|---|---|
| Application (Form No. 880n) | yes | yes | yes | yes |
| Copy of foreign trade contract | yes | yes | yes | no |
| Certificates of Analysis (CoA) with translation | yes | yes | yes | no |
| Clinical Trial Authorisation (CTA) details | yes | no | no | no |
| Packaging mock-ups / photos | yes | no | no | no |
| Decision to conduct quality evaluation | no | yes | no | no |
| Research plan / protocol | no | no | yes | no |
| Medical council (consilium) conclusion | no | no | no | yes |
| Copy of patient’s passport | no | no | no | yes |
| Consent to personal data processing | no | no | no | yes |
The specific batch import regime remains one of the few fast tracks for bringing an unregistered drug into Russia. Decree No. 913 opened this path to science. However, the advertised speed of 5 working days at the Ministry of Health can turn into 3–4 weeks at the very first error in the documents.
Regulatory Framework:
1. Decision of the Board of the Eurasian Economic Commission No. 30 dated April 21, 2015 «On Non-Tariff Regulation Measures»
2. Federal Law No. 61-FZ dated April 12, 2010 «On the Circulation of Medicines» (as amended by Federal Law No. 1-FZ dated January 30, 2024), Articles 47, 48, 49
3. Decree of the Government of the Russian Federation No. 853 dated June 1, 2021 «On Approval of the Rules for Importing Medicinal Products for Medical Use into the Russian Federation» (as amended on June 18, 2025)
4. Decree of the Government of the Russian Federation No. 913 dated June 18, 2025 (amending Decree No. 853)
5. Order of the Ministry of Health of the Russian Federation No. 880n dated August 25, 2021 «On Approval of the Administrative Regulation on Issuing Permits for the Import of a Specific Batch of Medicinal Products»
6. Order of the Ministry of Industry and Trade of the Russian Federation No. 3109 dated July 11, 2024 «On Approval of the Administrative Regulation on Issuing Licenses for the Export and/or Import of Specific Types of Goods»
7. Federal Law No. 152-FZ dated July 27, 2006 «On Personal Data»