Orphan drugs may now be imported in foreign packaging: which documents need a translation

On 30 September 2026 Russian Government Decree No. 1231 of 24.09.2026 was published. It allows registered original orphan and high-tech medicinal products to be imported into Russia and sold in packaging intended for other countries. The decree enters into force 10 days after publication and remains in effect for 6 years.

What has changed

For 12 months after a medicine is registered in Russia, it may be imported in foreign packaging. The condition: a label with information in Russian is stuck onto the secondary packaging (name, dosage, marketing authorisation holder, manufacturer, composition, batch number and expiry date, storage conditions, route of administration, dispensing conditions). Each pack must be accompanied by the instructions for use (package leaflet) translated into Russian.

Such a medicine may be placed on the market on the basis of a conclusion issued by the Ministry of Health. The application is filed by a legal entity through its personal account on the Gosuslugi portal or in the EGISZ health information system, and the Ministry reviews it within 5 working days.

Who it affects

Importers and distributors of medicines, representative offices of foreign pharmaceutical companies and legal entities that file the application under a power of attorney from another company.

Which documents need a translation

The decree expressly requires copies with a translation into Russian, certified in the established manner:

• the manufacturing licence issued in the manufacturer's country;
• the document confirming the manufacturer's compliance with the good manufacturing practice (GMP) rules of the manufacturer's country, if there is no EAEU GMP certificate;
• documents on the registration of the medicine in the foreign country;
• the instructions for medical use (package leaflet) approved by the foreign authority;
• the manufacturer's document confirming that the imported batch meets the registration requirements.

In addition, the applicant's power of attorney is submitted in Russian, and the trade name of the medicine is stated in the application with a translation. Incomplete or inaccurate documents are the first ground for refusing the conclusion.

What to do

• Check that no more than 12 months have passed since the medicine was registered in Russia: later applications will not be accepted.
• Collect the foreign documents in advance and order the translation as one package, so that terms and names match across all papers.

Send your documents to Stylus: we will translate licences, GMP certificates and leaflets into Russian and have them certified by the notary in the office next door.