New drug import rules from 2027: what the Ministry of Health proposes and what applicants should watch

The current Rules on the import of medicines for medical use (Government Resolution No. 853 of 1 June 2021) expire on 1 September 2027. In early September the Ministry of Health published on regulation.gov.ru a draft of a new resolution designed to run from 1 September 2027 to 1 September 2033. Public consultation is open until 18 September 2026. For companies importing products for clinical trials, registration and named-patient treatment, this is an opportunity to influence the text before it becomes binding.

What stays

The basic permit-based model remains: specific consignments of registered and unregistered medicines are imported on the basis of a Ministry of Health conclusion. The review period is no more than five working days, no fee is charged, and applications are filed electronically via the public services portal. Conclusions are proposed to become open-ended, with the details transmitted to the customs authorities electronically.

What changes

Quantity justification by purpose of import. Today, in drug development, the volume is justified by the production flow chart and material balance. According to Vademecum's account of the draft, the calculation is tied to the specific procedure: for preclinical studies, a plan or protocol with objectives, methodology and a needs calculation; for clinical trials, the dosing scheme, strengths, duration and number of participants; for registration and assessment, the quantity required for quality testing, with references to pharmacopoeial monographs and the expert body's calculations. For applicants this means the import package must be aligned with the study protocol or assessment plan in advance.

Medical device manufacturers - a separate route. Import of unregistered medicines for the manufacture of medical devices is taken out of the Ministry of Health conclusion procedure: instead, the purpose of import is confirmed by Roszdravnadzor (review period up to 10 working days, valid for one year).

Named-patient import - stricter. The medical board's protocol must be signed by its chair (currently the head of the medical organisation may sign). Re-use of a single protocol for new consignments is prohibited if a conclusion has already been issued for the entire volume it specifies; the exception is retained only for medicines prescribed for life - at present it extends to any long-term therapy.

New grounds for refusal: no record of the applicant in the Unified State Register of Legal Entities or of tax registration, and re-submission of a medical board protocol that has already been fully used.

Orphan drugs and the Circle of Kindness fund - no fundamental change. The draft keeps the existing construction: for products imported for the Circle of Kindness fund, the basis remains a decision of the fund's expert council to build a reserve; in other cases of import for a limited patient population, a separate Government act is still required, specifying the importer, product, form, strength, volume and disease.

What to watch

For foreign companies planning clinical trials and registration in Russia, the draft streamlines practice rather than erecting new barriers: open-ended conclusions and a five-day period are a plus; tying quantities to the protocol is extra work at the preparation stage. The changes are more sensitive for early-access programmes and named-patient import: narrowing the exception to lifelong prescriptions and banning protocol re-use will increase the frequency of applications for new medical board decisions in long-term but not lifelong therapy. This is the block worth addressing in comments on the draft. The document remains a draft: the text may change before 1 September 2027, and the current procedure under Resolution No. 853 applies in full.

Sources

Draft Government Resolution 'On approval of the Rules on the import of medicines for medical use' (regulation.gov.ru, September 2026); Government Resolution No. 853 of 1 June 2021; Vademecum (8 September 2026); Kommersant (8 September 2026); Pharmvestnik (8 September 2026); Recipe.ru (7 September 2026); PharmMedProm (September 2026).